Janssen CarePath is becoming J&J withMe. Our name may be changing, but our commitment to patients stays the same. Learn more 
Janssen CarePath is becoming J&J withMe. During this transition, you may see both program names in use.
At Johnson & Johnson, we are committed to helping people live fuller lives. Our J&J withMe program is here at every step to provide personalized support to help patients start and stay on their J&J medicines.
What is AKEEGA® (niraparib and abiraterone acetate)?
AKEEGA® is a prescription medicine used with prednisone to treat adults with prostate cancer:
Your healthcare provider will perform a test to make sure AKEEGA® is right for you.
It is not known if AKEEGA® is safe and effective in females.
It is not known if AKEEGA® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about AKEEGA®?
AKEEGA® may cause serious side effects including:
Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with AKEEGA® but can also be a sign of serious bone marrow problems, including MDS and AML. Tell your healthcare provider if you have any of the following symptoms during treatment with AKEEGA®:
|
|
Your healthcare provider will do blood tests to check your blood cell counts:
See “What are the possible side effects of AKEEGA®?” for more information about side effects.
Before taking AKEEGA®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AKEEGA® may affect the way other medicines work, and other medicines may affect how AKEEGA® works.
How should I take AKEEGA®?
What are the possible side effects of AKEEGA®?
AKEEGA® may cause serious side effects, including:
|
|
|
|
|
|
|
|
The most common side effects of AKEEGA® include:
|
|
|
AKEEGA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of AKEEGA®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information for AKEEGA®.
cp-401052v2
WHAT IS BALVERSA® (erdafitinib)?
BALVERSA® is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery:
Your healthcare provider will test your cancer for certain types of abnormal FGFR genes and make sure that BALVERSA® is right for you.
BALVERSA® is not recommended for the treatment of people who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
It is not known if BALVERSA® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before taking BALVERSA®, tell your healthcare provider about all of your medical conditions, including if you:
Females who can become pregnant:
Males with female partners who can become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.
What are the possible side effects of BALVERSA®?
BALVERSA® may cause serious side effects, including:
The most common side effects of BALVERSA® include:
|
|
Tell your healthcare provider right away if you develop any nail or skin problems including nails separating from the nail bed, nail pain, nail bleeding, breaking of the nails, color or texture changes in your nails, infected skin around the nail, an itchy skin rash, dry skin, or cracks in the skin.
BALVERSA® may affect fertility in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.
These are not all possible side effects of BALVERSA®. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep BALVERSA® out of the reach of children.
General information about the safe and effective use of BALVERSA®.
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use BALVERSA® for a condition for which it was not prescribed. Do not give BALVERSA® to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BALVERSA® that is written for healthcare professionals.
Please click here to see full BALVERSA® Prescribing Information.
cp-69606v7
WHAT IS CONCERTA® (methylphenidate HCl) extended-release tablets?
CONCERTA® is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in children 6 years of age and older and adults up to 65 years of age. CONCERTA® may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if CONCERTA® is safe and effective in children under 6 years of age. CONCERTA® has not been studied in adults older than 65 years of age.
CONCERTA® is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.
Keep CONCERTA® in a safe place to protect it from theft. Never give your CONCERTA® to anyone else because it may cause death or harm them. Selling or giving away CONCERTA® may harm others and is against the law.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CONCERTA®?
CONCERTA® may cause serious side effects, including:
Your healthcare provider should check you or your child carefully for heart problems before starting treatment with CONCERTA®. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with CONCERTA®.
Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with CONCERTA®, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
Do not take CONCERTA® if you or your child:
Before taking CONCERTA®, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONCERTA® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with CONCERTA®. Your healthcare provider will decide whether CONCERTA® can be taken with other medicines.
Especially tell your healthcare provider if you or your child take:
Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.
Do not start any new medicine during treatment with CONCERTA® without first talking to your healthcare provider.
HOW SHOULD I TAKE CONCERTA®?
If you or your child take too much CONCERTA®, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF CONCERTA®?
CONCERTA® may cause serious side effects, including:
Tell your healthcare provider if you or your child have any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with CONCERTA®.
The most common side effect of CONCERTA® in children is upper stomach-area (abdominal) pain.
The most common side effects of CONCERTA® in adults include:
|
|
These are not all the possible side effects of CONCERTA®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736).
Please see the full Prescribing Information, including Boxed WARNING and the Medication Guide for CONCERTA®.
cp-180018v3
What is DARZALEX® (daratumumab)?
DARZALEX® is a prescription medicine used to treat adults with multiple myeloma:
It is not known if DARZALEX® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not receive DARZALEX® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX®. See below for a complete list of ingredients.
Before you receive DARZALEX®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive DARZALEX®?
DARZALEX® may cause serious reactions, including:
The most common side effects of DARZALEX® include cold-like symptoms (upper respiratory infection); diarrhea; constipation; decreased red blood cells; nerve damage causing tingling, numbness, or pain; tiredness; swollen hands, ankles, or feet; nausea; cough; fever; shortness of breath; feeling weak.
These are not all the possible side effects of DARZALEX®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of DARZALEX®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about DARZALEX® that is written for health professionals.
Active ingredient: daratumumab.
Inactive ingredients: may include glacial acetic acid, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, sorbitol, and water for injection.
Please click here to see the Important Product Information.
cp-109238v8
What is DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)?
DARZALEX FASPRO® is a prescription medicine used to treat adult patients with multiple myeloma:
DARZALEX FASPRO® is a prescription medicine also used in combination with the medicines bortezomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed light chain (AL) amyloidosis. For light chain (AL) amyloidosis, DARZALEX FASPRO® is approved based on medical studies that measured how many patients responded to treatment. Continued approval may depend on the benefit demonstrated by additional data from medical studies.
It is not known if DARZALEX FASPRO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not receive DARZALEX FASPRO® if you have a history of a severe allergic reaction to daratumumab, hyaluronidase, or any of the ingredients in DARZALEX FASPRO®. See below for a complete list of ingredients in DARZALEX FASPRO®.
Before you receive DARZALEX FASPRO®, tell your healthcare provider about all of your medical conditions, including if you:
Before you receive DARZALEX FASPRO® for light chain (AL) amyloidosis, tell your healthcare provider if you have a history of heart problems. DARZALEX FASPRO® should not be used in light chain (AL) amyloidosis patients with highly advanced heart disease outside of clinical trials.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive DARZALEX FASPRO®?
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
DARZALEX FASPRO® may cause serious reactions, including:
The most common side effects of DARZALEX FASPRO® when used alone include cold-like symptoms (upper respiratory infection) and decreased red blood cell counts.
The most common side effects of DARZALEX FASPRO® used in combination therapy include:
These are not all the possible side effects of DARZALEX FASPRO®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of DARZALEX FASPRO®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about DARZALEX FASPRO® that is written for health professionals.
Active ingredient: daratumumab and hyaluronidase-fihj
Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, water for injection
Please click here to see the Product Information.
cp-205672v7
What are EDURANT® (rilpivirine) and EDURANT® PED?
EDURANT® and EDURANT® PED are prescription medicines that are used with:
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
If you take EDURANT® in combination with oral VOCABRIA (cabotegravir), you should also read the Patient Information that comes with oral VOCABRIA (cabotegravir).
It is not known if EDURANT® or EDURANT® PED is safe and effective in children less than 2 years of age or who weigh less than 31 lbs (14 kg).
IMPORTANT SAFETY INFORMATION
Who should not take EDURANT®?
Do not take EDURANT® or EDURANT® PED if you also take:
What should I tell my healthcare provider before taking EDURANT®?
Before taking EDURANT® or EDURANT® PED, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with EDURANT® or EDURANT® PED. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EDURANT® or EDURANT® PED.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT® or EDURANT® PED with other medicines.
How should I take EDURANT® or EDURANT® PED?
See the “Instructions for Use” for detailed instructions on how to prepare and give a dose of EDURANT® PED tablets for oral suspension.
What are the possible side effects of EDURANT® or EDURANT® PED?
EDURANT® or EDURANT® PED can cause serious side effects including:
Stop taking EDURANT® or EDURANT® PED and get medical help right away if you develop a rash with any of the following signs or symptoms:
|
|
The most common side effects of EDURANT® or EDURANT® PED include depression, headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects of EDURANT® or EDURANT® PED. If you experience these or other symptoms, contact your healthcare provider right away.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).
Please read the full Product Information for EDURANT® and EDURANT® PED and discuss any questions you have with your healthcare provider.
cp-51056v8
WHAT IS ELMIRON® (pentosan polysulfate sodium)?
ELMIRON® is a prescription medicine used to treat bladder pain or discomfort associated with interstitial cystitis. It is not known if ELMIRON® is safe and effective in children under 16 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ELMIRON® (pentosan polysulfate sodium) Capsules?
Serious side effects have been reported with the use of ELMIRON®, including:
Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes. Your doctor will discuss with you when to get your first eye examination and follow up exams, and whether the treatment should be continued.
Your risk of bleeding may be increased if you take ELMIRON® along with other medicines such as:
Tell your healthcare provider if you are taking any of these medicines.
Tell your healthcare provider if you are going to have surgery. Your healthcare provider may stop ELMIRON® before you have surgery.
Talk to your healthcare provider about when to stop taking ELMIRON® and when to start taking it again.
What should I tell my healthcare provider before taking ELMIRON®?
Tell your healthcare provider if you:
What are the possible side effects of ELMIRON®?
ELMIRON® may cause serious side effects including:
See “What is the most important information I should know about ELMIRON® (pentosan polysulfate sodium) Capsules?”
The most common side effects of ELMIRON® are:
These are not all the possible side effects of ELMIRON®.
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
How should I store ELMIRON®?
How should I take ELMIRON®?
Please click here to see full Prescribing Information and read the Medication Guide.
cp-11575v5
What is ERLEADA®?
ERLEADA® (apalutamide) is a prescription medicine used for the treatment of prostate cancer:
OR
It is not known if ERLEADA® is safe and effective in females.
It is not known if ERLEADA® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before taking ERLEADA®, tell your healthcare provider about all your medical conditions, including if you:
Talk with your healthcare provider if you have questions about birth control.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERLEADA® can interact with many other medicines.
You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA®.
Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ERLEADA®?
What are the possible side effects of ERLEADA®?
ERLEADA® may cause serious side effects including:
|
|
|
|
The most common side effects of ERLEADA® include:
|
|
Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment with ERLEADA® if you have certain side effects.
ERLEADA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA® and for 3 months after the last dose of ERLEADA®.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ERLEADA®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information for ERLEADA®.
cp-50508v5
INDICATIONS
Infliximab is a prescription medication used to treat:
Crohn's Disease
Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven't responded well to other therapies
Pediatric Crohn's Disease
Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn's disease who haven't responded well to other therapies
Ulcerative Colitis
Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies
Pediatric Ulcerative Colitis
Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis
Can reduce signs and symptoms, help stop further joint damage, and improve physical function in adult patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Psoriatic Arthritis
Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in adult patients with psoriatic arthritis
Ankylosing Spondylitis
Can reduce signs and symptoms in adult patients with active ankylosing spondylitis
Plaque Psoriasis
Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if Infliximab is appropriate considering other available therapies
IMPORTANT SAFETY INFORMATION
Only your doctor can recommend a course of treatment after checking your health condition. Infliximab can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections which include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body or caused infections in certain areas (such as skin). Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with Infliximab.
Unusual cancers have been reported in children and teenage patients taking tumor necrosis factor (TNF) blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in male teenagers or young men with Crohn’s disease or ulcerative colitis who were taking Infliximab and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including Infliximab, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.
It is not known if Infliximab is safe and effective in children under 6 years of age.
What should I tell my doctor before I take Infliximab?
You should let your doctor know if you have or ever had any of the following:
Also tell your doctor if you:
What should I watch for and talk to my doctor about before or while taking Infliximab?
The following serious (sometimes fatal) side effects have been reported in people taking Infliximab.
You should tell your doctor right away if you have any of the signs listed below:
The more common side effects of Infliximab include respiratory infections (such as sinus infections and sore throat), headache, coughing and stomach pain.
Please read the full Prescribing Information, including Boxed Warning, and Medication Guide for Infliximab and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
cp-253863v1
About INTELENCE® (etravirine)
INTELENCE® does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control your HIV infection and decrease HIV-related illnesses.
Ask your healthcare provider if INTELENCE® is right for you.
Important Safety Information
What are the possible side effects of INTELENCE®?
INTELENCE® can cause serious side effects including:
|
|
|
|
|
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.
What should I tell my healthcare provider before taking INTELENCE®?
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Product Information in PDF format for more details.
cp-63740v3
INDICATIONS
INVEGA® (paliperidone) extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressant therapy in adults and for the treatment of schizophrenia in adults.
Important Safety Information
INVEGA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). INVEGA® is not for treating dementia-related psychosis.
Do not receive INVEGA® if you are allergic to paliperidone, risperidone, or any of the ingredients in INVEGA®.
Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive INVEGA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever, severe muscle stiffness, confusion, loss of consciousness, or changes in your breathing, heartbeat and blood pressure.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. Symptoms may go away partially or completely if therapy is stopped.
One risk of INVEGA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your healthcare professional about any current or past heart problems. Because these problems could mean you’re having a heart rhythm abnormality, contact your healthcare professional IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).
Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:
High blood sugar and diabetes have been reported with INVEGA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your healthcare professional if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.
Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your healthcare professional while on treatment.
Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment. For adolescent patients (12-17 years of age) weight gain should be assessed against that expected with normal growth.
INVEGA® and similar medicines can raise the blood levels of a hormone called prolactin, and blood levels of prolactin remain high with continued use. This may result in some side effects, including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach, or small or large intestine) should talk to their healthcare professional before taking INVEGA®.
Some people taking INVEGA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare provider for the potential risk of falls.
Blood problems such as low numbers of white blood cells have been reported in patients taking INVEGA® and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your healthcare professional may choose to test your blood as you start therapy with INVEGA®.
INVEGA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA® affects you.
INVEGA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.
INVEGA® should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.
Some medications interact with INVEGA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking INVEGA®.
Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if INVEGA® will harm your unborn baby. If you become pregnant while taking INVEGA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry. Infants born to women who are treated with INVEGA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. INVEGA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA®.
INVEGA® may impair fertility, which is reversible. Speak to your healthcare professional if you plan to become pregnant.
The most common side effects that occurred with INVEGA® in the treatment of schizophrenia in adults were: abnormal muscle movements (including tremor [shaking], shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes); feeling of inner restlessness or needing to be constantly moving; and fast heartbeat.
The most common side effects that occurred with INVEGA® in the treatment of schizoaffective disorder in adults were: abnormal muscle movements (including tremor [shaking], shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), sleepiness, heartburn, constipation, weight increase, and sore throat.
This is not a complete list of all possible side effects. Ask your healthcare professional or treatment team if you have any questions or want more information.
If you have any questions about INVEGA® or your therapy, talk with your healthcare professional.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA® and discuss any questions you have with your healthcare professional.
cp-64199v2
INDICATION
INVEGA HAFYERA™ is a prescription medicine given by injection by a healthcare provider 1 time every 6 months and used for the treatment of schizophrenia in adults who have been adequately treated with either:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about INVEGA HAFYERA™?
INVEGA HAFYERA™ may cause serious side effects, including:
Do not receive INVEGA HAFYERA™ if you are allergic to paliperidone palmitate, risperidone, or any of the ingredients in INVEGA HAFYERA™. See the end of Patient Information leaflet for a complete list of ingredients in INVEGA HAFYERA™.
Before receiving INVEGA HAFYERA™, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
INVEGA HAFYERA™ and other medicines may affect each other causing possible serious side effects. INVEGA HAFYERA™ may affect the way other medicines work, and other medicines may affect how INVEGA HAFYERA™ works.
Your healthcare provider can tell you if it is safe to receive INVEGA HAFYERA™ with your other medicines. Do not start or stop any medicines during treatment with INVEGA HAFYERA™ without talking to your healthcare provider first.
Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine.
How will I receive INVEGA HAFYERA™?
What should I avoid while receiving INVEGA HAFYERA™?
What are the possible side effects of INVEGA HAFYERA™?
INVEGA HAFYERA™ may cause serious side effects, including:
|
|
Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with INVEGA HAFYERA™:
|
|
The most common side effects of INVEGA HAFYERA™ include:
|
|
These are not all the possible side effects of INVEGA HAFYERA™.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about INVEGA HAFYERA™
Medicines are sometimes prescribed for purposes other than those listed. You can ask your pharmacist or healthcare provider for information about INVEGA HAFYERA™ that is written for health professionals.
Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA HAFYERA™ and discuss any questions you have with your healthcare professional.
cp-256048v1
INDICATIONS
INVEGA SUSTENNA® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) Extended-Release Injectable Suspension is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used for schizoaffective disorder in adults, either alone or in combination with other medicines such as mood stabilizers or antidepressants, and is used to treat schizophrenia in adults.
IMPORTANT SAFETY INFORMATION
|
What is the most important information I should know about INVEGA SUSTENNA®? INVEGA SUSTENNA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA SUSTENNA® is not for treating dementia-related psychosis. |
Do not receive INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA SUSTENNA® ingredients.
Before you receive INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.
What should I avoid while receiving INVEGA SUSTENNA®?
INVEGA SUSTENNA® may cause serious side effects, including:
The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.
Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
General information about the safe and effective use of INVEGA SUSTENNA®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA SUSTENNA® for a condition for which it was not prescribed. Do not give INVEGA SUSTENNA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare professional for information about INVEGA SUSTENNA® that is written for healthcare professionals.
This Patient Information leaflet summarizes the most important information about INVEGA SUSTENNA®. If you would like more information, talk with your healthcare professional.
You can ask your healthcare professional or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegasustenna.com or call 1-800-526-7736.
Please read the full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional.
cp-64205v2
INDICATION
INVEGA TRINZA® (3-month paliperidone palmitate) is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least 4 months in adults.
IMPORTANT SAFETY INFORMATION
|
What is the most important information I should know about INVEGA TRINZA®? INVEGA TRINZA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA TRINZA® is not approved for treating dementia-related psychosis. |
Do not receive INVEGA TRINZA® if you are allergic to paliperidone, palmitate, risperidone, or any of the ingredients in INVEGA TRINZA®. See end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA TRINZA® ingredients.
Before you receive INVEGA TRINZA®, tell your healthcare professional about all your medical conditions, including if you:
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.
What should I avoid while receiving INVEGA TRINZA®?
INVEGA TRINZA® may cause serious side effects, including:
The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness, and shuffling walk.
Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA TRINZA®. For more information, ask your healthcare professional or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of INVEGA TRINZA®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA TRINZA® for a condition for which it was not prescribed. Do not give INVEGA TRINZA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare professional for information about INVEGA TRINZA® that is written for health professionals.
The Patient Information leaflet summarizes the most important information about INVEGA TRINZA®. If you would like more information, talk with your healthcare professional.
You can ask your healthcare professional or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegatrinzahcp.com or call 1-800-526-7736.
Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA TRINZA® and discuss any questions you have with your healthcare professional.
cp-64209v2
WHAT IS INVOKAMET® OR INVOKAMET® XR?
INVOKAMET® contains two prescription medicines called canagliflozin (INVOKANA®) and metformin HCl (GLUCOPHAGE®). INVOKAMET® XR contains two prescription medicines called canagliflozin (INVOKANA®) and metformin.
IMPORTANT SAFETY INFORMATION
INVOKAMET® or INVOKAMET® XR can cause serious side effects, including:
You have a higher chance of getting lactic acidosis with INVOKAMET® or INVOKAMET® XR if you have conditions such as: severe kidney problems, or your kidneys are affected by certain X-ray tests that use injectable dye; liver problems; drink alcohol very often (or drink a lot of alcohol in short-term); get dehydrated; have surgery; have a heart attack, severe infection, or stroke; are 65 years of age or older.
|
|
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKAMET® or INVOKAMET® XR if you:
Before taking INVOKAMET® or INVOKAMET® XR, tell your doctor about all of your medical conditions, including if you: have type 1 diabetes or have had diabetic ketoacidosis; have a serious infection; have a history of infection of the vagina or penis; have a history of amputation; have had blocked or narrowed blood vessels, usually in your leg; have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have moderate to severe kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; have ever had an allergic reaction to INVOKAMET® or INVOKAMET® XR; are going to get an injection of dye or contrast agents for an x-ray procedure; have heart problems, including congestive heart failure; are going to have surgery (your doctor may stop your INVOKAMET® or INVOKAMET® XR before you have surgery; talk to your doctor if you are having surgery about when to stop taking and when to start it again); are eating less or there is a change in your diet; are dehydrated; have a decrease in your insulin dose; have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas; drink alcohol very often or drink a lot of alcohol in the short-term; have low levels of vitamin B12 or calcium in your blood.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKAMET® or INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking INVOKAMET® or INVOKAMET® XR, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
If you are premenopausal (before the “change of life”), and do not have periods regularly or at all, INVOKAMET® or INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKAMET® or INVOKAMET® XR, if you are not planning to become pregnant. Tell your doctor right away if you become pregnant while taking INVOKAMET® or INVOKAMET® XR.
INVOKAMET® or INVOKAMET® XR may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking INVOKAMET® or INVOKAMET® XR. Do not breastfeed while taking INVOKAMET® or INVOKAMET® XR.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVOKAMET® or INVOKAMET® XR may affect the way other medicines work and other medicines may affect how INVOKAMET® or INVOKAMET® XR works.
Possible Side Effects of INVOKAMET® or INVOKAMET® XR
INVOKAMET® or INVOKAMET® XR may cause serious side effects, including:
Other common side effects of INVOKAMET® or INVOKAMET® XR include: nausea and vomiting; diarrhea; weakness; gas; upset stomach; indigestion; headache; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
These are not all the possible side effects of INVOKAMET® or INVOKAMET® XR.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please read full Product Information, including Boxed Warning, and Medication Guide for INVOKAMET® and INVOKAMET® XR.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
cp-06259v11
WHAT IS INVOKAMET® OR INVOKAMET® XR?
INVOKAMET® contains two prescription medicines called canagliflozin (INVOKANA®) and metformin HCl (GLUCOPHAGE®). INVOKAMET® XR contains two prescription medicines called canagliflozin (INVOKANA®) and metformin.
IMPORTANT SAFETY INFORMATION
INVOKAMET® or INVOKAMET® XR can cause serious side effects, including:
You have a higher chance of getting lactic acidosis with INVOKAMET® or INVOKAMET® XR if you have conditions such as: severe kidney problems, or your kidneys are affected by certain X-ray tests that use injectable dye; liver problems; drink alcohol very often (or drink a lot of alcohol in short-term); get dehydrated; have surgery; have a heart attack, severe infection, or stroke; are 65 years of age or older.
|
|
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKAMET® or INVOKAMET® XR if you:
Before taking INVOKAMET® or INVOKAMET® XR, tell your doctor about all of your medical conditions, including if you: have type 1 diabetes or have had diabetic ketoacidosis; have a serious infection; have a history of infection of the vagina or penis; have a history of amputation; have had blocked or narrowed blood vessels, usually in your leg; have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have moderate to severe kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; have ever had an allergic reaction to INVOKAMET® or INVOKAMET® XR; are going to get an injection of dye or contrast agents for an x-ray procedure; have heart problems, including congestive heart failure; are going to have surgery (your doctor may stop your INVOKAMET® or INVOKAMET® XR before you have surgery; talk to your doctor if you are having surgery about when to stop taking and when to start it again); are eating less or there is a change in your diet; are dehydrated; have a decrease in your insulin dose; have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas; drink alcohol very often or drink a lot of alcohol in the short-term; have low levels of vitamin B12 or calcium in your blood.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKAMET® or INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking INVOKAMET® or INVOKAMET® XR, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
If you are premenopausal (before the “change of life”), and do not have periods regularly or at all, INVOKAMET® or INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKAMET® or INVOKAMET® XR, if you are not planning to become pregnant. Tell your doctor right away if you become pregnant while taking INVOKAMET® or INVOKAMET® XR.
INVOKAMET® or INVOKAMET® XR may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking INVOKAMET® or INVOKAMET® XR. Do not breastfeed while taking INVOKAMET® or INVOKAMET® XR.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVOKAMET® or INVOKAMET® XR may affect the way other medicines work and other medicines may affect how INVOKAMET® or INVOKAMET® XR works.
Possible Side Effects of INVOKAMET® or INVOKAMET® XR
INVOKAMET® or INVOKAMET® XR may cause serious side effects, including:
Other common side effects of INVOKAMET® or INVOKAMET® XR include: nausea and vomiting; diarrhea; weakness; gas; upset stomach; indigestion; headache; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
These are not all the possible side effects of INVOKAMET® or INVOKAMET® XR.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please read full Product Information, including Boxed Warning, and Medication Guide for INVOKAMET® and INVOKAMET® XR.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
cp-06259v11
WHAT IS INVOKANA®?
IMPORTANT SAFETY INFORMATION
INVOKANA® can cause serious side effects, including:
|
|
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKANA® if you:
Before taking INVOKANA®, tell your doctor if you: have type 1 diabetes or have had diabetic ketoacidosis; have a serious infection; have a history of infection of the vagina or penis; have a history of amputation; have had blocked or narrowed blood vessels (usually in your leg); have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery (your doctor may stop your INVOKANA® before you have surgery; talk to your doctor if you are having surgery about when to stop taking INVOKANA® and when to start it again); are eating less or there is a change in diet; are dehydrated; have a decrease in your insulin dose; have or have had pancreas problems; drink alcohol very often (or drink a lot of alcohol in the short-term); or ever had an allergic reaction to INVOKANA®.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.
Tell your doctor about all the medicines you take, including prescription and non‑prescription medicines, vitamins, and herbal supplements.
INVOKANA® may affect the way other medicines work, and other medicines may affect how INVOKANA® works.
Possible Side Effects of INVOKANA®
INVOKANA® may cause serious side effects, including:
The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
These are not all the possible side effects of INVOKANA®.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1‑800‑526-7736.
Please read full Product Information and Medication Guide for INVOKANA®.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
cp-68573v7
What is OPSUMIT® (macitentan)?
OPSUMIT® is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). PAH is high blood pressure in the arteries of your lungs. OPSUMIT® can:
It is not known if OPSUMIT® is safe and effective in children.
The most important information about OPSUMIT® (macitentan)
Do not take OPSUMIT® if you are pregnant or trying to get pregnant. OPSUMIT® can cause serious birth defects if taken while pregnant.
Women who are able to get pregnant must have negative pregnancy tests:
Your doctor will decide when you should take pregnancy tests.
You are medically able to get pregnant if you are a woman who fits all of the following guidelines:
You are not medically able to get pregnant if you are a woman who fits at least 1 of the following guidelines:
While taking OPSUMIT®, and for 1 month after stopping OPSUMIT®, women who are able to get pregnant must use 2 acceptable forms of birth control. Women who have had a tubal sterilization, a progesterone implant, or have an IUD (intrauterine device) do not need a second form of birth control. Talk to your doctor or gynecologist about which birth control to use while on OPSUMIT®. If you decide to change your form of birth control, talk with your doctor or gynecologist. This way you can be sure to choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.
It’s important not to have unprotected sex while taking OPSUMIT®. Tell your doctor right away if you have unprotected sex, think your birth control has failed, miss a menstrual period, or think you may be pregnant. He or she may recommend using a form of emergency birth control.
If you are the parent or caregiver of a female child who started taking OPSUMIT® before reaching puberty, check with your child regularly for any signs of puberty. Your child may reach puberty before having her first menstrual period. Talk to your doctor if you think your child is showing signs of puberty or if you have any questions about the signs of puberty.
Before starting OPSUMIT®, women must enroll in a program called the Macitentan Risk Evaluation and Mitigation Strategy (REMS). If you are a woman who is able to get pregnant, you must talk to your doctor to learn the benefits and risks of OPSUMIT®. You must also agree to all of the instructions in the program. Men who are prescribed OPSUMIT® do not need to enroll in this program.
Who should not take OPSUMIT®?
Do not take OPSUMIT® if you are pregnant, plan to become pregnant, or become pregnant during treatment with OPSUMIT®. OPSUMIT® can cause serious birth defects. See "The most important information about OPSUMIT®."
Do not take OPSUMIT® if you are allergic to macitentan or any of the ingredients in OPSUMIT®. See the Medication Guide for a complete list of ingredients in OPSUMIT®.
Talk to your doctor about all your medical conditions, as well as all the medicines, vitamins, and supplements you take. OPSUMIT® and other medicines may affect each other causing side effects. Tell your doctor right away if you take an HIV medicine. Do not start any new medicine until you check with your doctor.
What should I avoid while taking OPSUMIT®?
What are the possible side effects of OPSUMIT®?
OPSUMIT® can cause serious side effects, including:
The most common side effects are:
Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of OPSUMIT®. For more information, ask your doctor or pharmacist.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information and Medication Guide, including an Important Warning about Serious Birth Defects, for OPSUMIT®.
cp-113980v5
What is OPSYNVI® (macitentan and tadalafil)?
OPSYNVI® is a prescription medicine that contains 2 medicines called macitentan and tadalafil. OPSYNVI® is used for long-term treatment of adults with pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
It is not known if OPSYNVI® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about OPSYNVI® (macitentan and tadalafil)?
OPSYNVI® can cause serious birth defects if taken during pregnancy. Females must not be pregnant when they start taking OPSYNVI® or become pregnant during treatment with OPSYNVI® or for 1 month after stopping treatment with OPSYNVI®.
Females who are able to get pregnant must have a negative pregnancy test before beginning treatment, each month during treatment and for 1 month after stopping treatment with OPSYNVI®. Your doctor will decide when to do the pregnancy test.
Females who are able to get pregnant must use 2 acceptable forms of birth control during treatment with OPSYNVI®, and for 1 month after stopping OPSYNVI® because the medicine may still be in the body. If you have had a tubal sterilization, have a progesterone implant, or have an IUD (intrauterine device), these methods can be used without another form of birth control. Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with OPSYNVI®. If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.
Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may talk with you about using emergency birth control.
Tell your doctor right away if you miss a menstrual period or think you may be pregnant.
Females can only receive OPSYNVI® through a restricted program called the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS). If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of OPSYNVI®, and agree to all of the instructions in the Macitentan-Containing Products REMS. Males can receive OPSYNVI® without taking part in the Macitentan-Containing Products REMS.
Who should not take OPSYNVI® (macitentan and tadalafil)?
Do not take OPSYNVI® if you:
Before taking OPSYNVI®, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking OPSYNVI® with other medicines may affect the way OPSYNVI® and the other medicines work, and may increase your risk of side effects. Do not start any new medicine until you check with your doctor. Especially tell your doctor if you take:
|
|
|
Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list and show it to your doctor or pharmacist when you get a new medicine.
What should I avoid while taking OPSYNVI®?
Do not have more than 4 alcohol-containing drinks in a short period of time during treatment with OPSYNVI®. Drinking too much alcohol can increase your chances of getting low blood pressure, increased heart rate, dizziness and headache.
What are the possible side effects of OPSYNVI®?
OPSYNVI® can cause serious side effects, including:
|
|
The most common side effects of OPSYNVI® include:
These are not all the possible side effects of OPSYNVI®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read full Prescribing Information, including Boxed Warning, and Medication Guide for OPSYNVI® and discuss any questions you have with your doctor.
cp-443045v1
WHAT IS PONVORY®?
PONVORY® is a prescription medicine that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
It is not known if PONVORY® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PONVORY®?
PONVORY® may cause serious side effects, including:
|
|
Your healthcare provider may delay starting or may stop your PONVORY® treatment if you have an infection.
Only Start your treatment with PONVORY® using the Starter Pack. You must use the PONVORY® Starter Pack by slowly increasing the dose over a 14-day period to help reduce the effect of slowing of your heart rate. It is important to follow the recommended dosing instructions.
Call your healthcare provider if you experience the following symptoms of slow heart rate:
|
|
Do not take PONVORY® if you:
Talk to your healthcare provider if you have any of these conditions, or do not know if you have any of these conditions.
Before you take PONVORY®, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Using PONVORY® and other medicines together may affect each other causing serious side effects. Especially tell your healthcare provider if you take or have taken: Medicines to control your heart rhythm (antiarrhythmics), or blood pressure (antihypertensives), or heart-beat (such as calcium channel blockers or beta-blockers); medicines that affect your immune system, such as alemtuzumab; and medicines such as rifampin, phenytoin, or carbamazepine.
You should not receive live vaccines during treatment with PONVORY®, for at least 1 month before taking PONVORY®, and for 1 to 2 weeks after you stop taking PONVORY®. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with PONVORY®.
Talk with your healthcare provider if you are not sure if you take any of these medicines.
HOW SHOULD I TAKE PONVORY®?
What are the possible side effects of PONVORY®?
PONVORY® may cause serious side effects, including:
|
|
Call your healthcare provider right away if you have any of the following symptoms:
|
|
|
|
The most common side effects of PONVORY® include:
These are not all the possible side effects of PONVORY®. For more information, ask your healthcare provider or pharmacist. See “What is the most important information I should know about PONVORY®?”
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please see full Prescribing Information and Medication Guide.
Trademarks are those of their respective owners.
cp-214883v2
WHAT IS PREZCOBIX®?
PREZCOBIX® is a prescription medicine that is used with other Human Immunodeficiency Virus Type 1 (HIV-1) medicines to treat HIV-1 infection in adults and in children who weigh at least 88 pounds (40 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). PREZCOBIX® contains prescription medicines darunavir and cobicistat. It is not known if PREZCOBIX® is safe and effective in children weighing less than 88 pounds (40 kg).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PREZCOBIX®?
|
|
|
|
What should I tell my healthcare provider before taking PREZCOBIX®?
Tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, topical creams, vitamins, and herbal supplements. Some medicines interact with PREZCOBIX®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
What are the possible side effects of PREZCOBIX®?
PREZCOBIX® may cause serious side effects including:
The most common side effects include:
|
|
These are not all the possible side effects of PREZCOBIX®. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please read full Product Information for PREZCOBIX® for more details.
cp-33793v9
What is PREZISTA®?
PREZISTA® (darunavir) is a prescription HIV-1 (Human Immunodeficiency Virus type-1) medicine used with NORVIR® (ritonavir) and other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
PREZISTA® should not be used in children under 3 years of age.
When used with other antiretroviral medicines to treat HIV-1 infection, PREZISTA® may help:
PREZISTA® is always taken with and at the same time as NORVIR® (ritonavir) in combination with other HIV-1 medicines for the treatment of HIV-1 infection in adults. PREZISTA® should also be taken with food.
PREZISTA® does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.
Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.
Please read the Important Safety Information and talk to your healthcare provider to learn if PREZISTA® is right for you.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PREZISTA®?
Who should not take PREZISTA®?
Do not take PREZISTA® with any medicine that contains: alfuzosin, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, ergot-containing medicines (dihydroergotamine, ergotamine tartrate, methylergonovine), ivabradine, lomitapide, lovastatin, lurasidone, midazolam (when taken by mouth), naloxegol, pimozide, ranolazine, rifampin, sildenafil when used for the treatment of pulmonary arterial hypertension (PAH), simvastatin, St. John’s wort (Hypericum perforatum), or triazolam.
Serious problems can happen if you or your child takes any of these medicines with PREZISTA®. This is not a complete list of medicines. Therefore, tell your healthcare provider about all medicines you take.
What should I tell my healthcare provider before taking PREZISTA®?
Before taking PREZISTA®, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, topical creams, vitamins, and herbal supplements. Some medicines interact with PREZISTA®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
What are the possible side effects of PREZISTA®?
PREZISTA® may cause serious side effects, including:
The most common side effects of PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting.
These are not all the possible side effects of PREZISTA®. For more information, ask your healthcare provider. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Do not change your dose or stop treatment with PREZISTA® without talking to your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please refer to the NORVIR® (ritonavir) Patient Information Leaflet for additional information on precautionary measures.
Please read the full Product Information for PREZISTA® for more details.
cp-07235v6
WHAT IS REMICADE®?
REMICADE® is a prescription medication used to treat:
Crohn's Disease
Pediatric Crohn's Disease
Ulcerative Colitis
Pediatric Ulcerative Colitis
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Plaque Psoriasis
IMPORTANT SAFETY INFORMATION
Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections which include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body or caused infections in certain areas (such as skin). Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.
Unusual cancers have been reported in children and teenage patients taking tumor necrosis factor (TNF) blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in male teenagers or young men with Crohn’s disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.
It is not known if REMICADE® is safe and effective in children under 6 years of age.
What should I tell my doctor before I take REMICADE®?
You should let your doctor know if you have or ever had any of the following:
Also tell your doctor if you:
What should I watch for and talk to my doctor about before or while taking REMICADE®?
The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.
You should tell your doctor right away if you have any of the signs listed below:
The more common side effects of REMICADE® include respiratory infections (such as sinus infections and sore throat), headache, coughing and stomach pain.
Please read the full Prescribing Information and Medication Guide for REMICADE® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
cp-53017v3
WHAT IS RISPERDAL® (risperidone)?
RISPERDAL® (risperidone) is used for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION FOR RISPERDAL®
|
RISPERDAL® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). RISPERDAL® is not for treating dementia-related psychosis. |
Do not receive RISPERDAL® if you are allergic to paliperidone, risperidone, or any of the ingredients in RISPERDAL®.
Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive RISPERDAL®. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; or changes in your breathing, heartbeat, and blood pressure.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. Symptoms may go away partially or completely if therapy is stopped.
Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:
High blood sugar and diabetes have been reported with RISPERDAL® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.
Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.
Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.
RISPERDAL® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breast producing milk; the development of breasts by males; and problems with erection.
Some people taking RISPERDAL® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.
Blood problems such as low numbers of white blood cells have been reported in patients taking RISPERDAL® and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with RISPERDAL®.
Painful, long-lasting erections have been reported with the use of RISPERDAL®. Call your doctor immediately if you think you are having this problem.
RISPERDAL® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
RISPERDAL® may increase difficulty in swallowing that may cause food or liquid to get into your lungs.
RISPERDAL® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how RISPERDAL® affects you.
RISPERDAL® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Some medications interact with RISPERDAL®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL®.
Before you receive RISPERDAL®, tell your healthcare provider about all your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if RISPERDAL® will harm your unborn baby. If you become pregnant while taking RISPERDAL®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visiting http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Infants born to women who are treated with RISPERDAL® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. RISPERDAL® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive RISPERDAL®.
RISPERDAL® may impair fertility, which is reversible. Speak to your healthcare provider if you plan to become pregnant.
The most common side effects observed in clinical trials with RISPERDAL® were sleepiness, slow movements (including tremor [shaking], stiffness, and a shuffling walk), feeling of inner restlessness or needing to be constantly moving, twisting movements that you cannot control, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, indigestion, diarrhea, increased saliva, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, infection of the nose and throat, and pain in the throat and upper windpipe.
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the full Prescribing Information, including Boxed WARNING, for RISPERDAL® and discuss any questions you have with your healthcare professional.
cp-64211v2
What is RISPERDAL CONSTA®?
RISPERDAL CONSTA® (risperidone) is used for the treatment of schizophrenia and for the longer-term treatment of Bipolar I Disorder.
IMPORTANT SAFETY INFORMATION FOR RISPERDAL CONSTA®
|
RISPERDAL CONSTA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). RISPERDAL CONSTA® is not for treating dementia-related psychosis. |
Do not receive RISPERDAL CONSTA® if you are allergic to paliperidone, risperidone, or any of the ingredients in RISPERDAL CONSTA®.
Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive RISPERDAL CONSTA®. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms: high fever, severe muscle stiffness, confusion, loss of consciousness, or changes in your breathing, heartbeat and blood pressure.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. Elderly female patients appear to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. This condition can develop after a brief period of therapy at low doses, although this is much less common. Symptoms may go away partially or completely if therapy is stopped.
Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:
High blood sugar and diabetes have been reported with RISPERDAL CONSTA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your healthcare professional if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.
Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your healthcare professional while on treatment.
Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.
RISPERDAL CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and problems with erection.
Some people taking RISPERDAL CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.
Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your healthcare professional may choose to test your blood as you start therapy with RISPERDAL CONSTA®.
RISPERDAL CONSTA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how RISPERDAL CONSTA® affects you.
RISPERDAL CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
RISPERDAL CONSTA® may increase difficulty in swallowing that may cause food or liquid to get into your lungs.
Painful, long lasting erections have been reported with the use of RISPERDAL CONSTA®. Call your healthcare professional immediately if you think you are having this problem.
Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if RISPERDAL CONSTA® will harm your unborn baby. If you become pregnant while taking RISPERDAL CONSTA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry. Infants born to women who are treated with RISPERDAL CONSTA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. RISPERDAL CONSTA® can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive RISPERDAL CONSTA®.
RISPERDAL CONSTA® may impair fertility, which is reversible. Speak to your healthcare provider if you plan to become pregnant.
RISPERDAL CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
Some medications interact with RISPERDAL CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL CONSTA®.
In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of schizophrenia were headache, slow movements (including tremor [shaking], stiffness, and a shuffling walk), dizziness; feeling of inner restlessness or needing to be constantly moving; tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.
In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and slow movements (including with tremor [shaking], stiffness, and a shuffling walk) and tremor (when used with lithium or valproate).
This is not a complete list of all possible side effects. Ask your healthcare professional or treatment team if you have any questions or want more information.
If you have any questions about RISPERDAL CONSTA® or your therapy, talk with your healthcare professional.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here to read the full Prescribing Information, including Boxed WARNING, for RISPERDAL CONSTA® and discuss any questions you have with your healthcare professional.
cp-64215v2
What is RYBREVANT® (amivantamab-vmjw)?
RYBREVANT® is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and has certain abnormal epidermal growth factor receptor (EGFR) gene(s):
Your healthcare provider will perform a test to make sure that RYBREVANT® or RYBREVANT® in combination with LAZCLUZE™ is right for you.
It is not known if RYBREVANT® or LAZCLUZE™ is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before you receive RYBREVANT® as a single agent or in combination, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Males who have female partners who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LAZCLUZE™ may affect the way other medicines work, and other medicines may affect how LAZCLUZE™ works.
You should not start or stop any medicine before you talk with your healthcare provider that prescribed LAZCLUZE™.
How will I receive RYBREVANT®?
How should I take LAZCLUZE™?
What should I avoid while receiving RYBREVANT® and/or LAZCLUZE™?
RYBREVANT® and RYBREVANT® in combination with LAZCLUZE™ can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with RYBREVANT® and/or LAZCLUZE™. Wear protective clothing and use sunscreen during treatment with RYBREVANT® and/or LAZCLUZE™.
What are the possible side effects of RYBREVANT® or LAZCLUZE™?
RYBREVANT® and LAZCLUZE™ may cause serious side effects, including:
|
|
|
|
Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get new or worsening eye problems during treatment with RYBREVANT® or LAZCLUZE™. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.
The most common side effects of RYBREVANT® in combination with LAZCLUZE™ (lazertinib) include:
|
|
The most common side effects of RYBREVANT® in combination with carboplatin and pemetrexed include:
|
|
The most common side effects of RYBREVANT® when given alone:
|
|
LAZCLUZE™ may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
Your healthcare provider may temporarily stop, decrease your dose, or completely stop your treatment with RYBREVANT® or LAZCLUZE™ if you have serious side effects.
These are not all of the possible side effects of RYBREVANT® or LAZCLUZE™.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of RYBREVANT®:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
You can ask your healthcare provider or pharmacist for information about RYBREVANT® that is written for health professionals.
General information about the safe and effective use of LAZCLUZE™:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LAZCLUZE™ for a condition for which it was not prescribed. Do not give LAZCLUZE™ to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about LAZCLUZE™ that is written for health professionals.
Please read full Prescribing Information for RYBREVANT®.
Please read full Prescribing Information for LAZCLUZE™.
cp-213277v5
What is RYBREVANT® (amivantamab-vmjw)?
RYBREVANT® is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and has certain abnormal epidermal growth factor receptor (EGFR) gene(s):
Your healthcare provider will perform a test to make sure that RYBREVANT® or RYBREVANT® in combination with LAZCLUZE™ is right for you.
It is not known if RYBREVANT® or LAZCLUZE™ is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before you receive RYBREVANT® as a single agent or in combination, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Males who have female partners who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LAZCLUZE™ may affect the way other medicines work, and other medicines may affect how LAZCLUZE™ works.
You should not start or stop any medicine before you talk with your healthcare provider that prescribed LAZCLUZE™.
How will I receive RYBREVANT®?
How should I take LAZCLUZE™?
What should I avoid while receiving RYBREVANT® and/or LAZCLUZE™?
RYBREVANT® and RYBREVANT® in combination with LAZCLUZE™ can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with RYBREVANT® and/or LAZCLUZE™. Wear protective clothing and use sunscreen during treatment with RYBREVANT® and/or LAZCLUZE™.
What are the possible side effects of RYBREVANT® or LAZCLUZE™?
RYBREVANT® and LAZCLUZE™ may cause serious side effects, including:
|
|
|
|
Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get new or worsening eye problems during treatment with RYBREVANT® or LAZCLUZE™. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.
The most common side effects of RYBREVANT® in combination with LAZCLUZE™ (lazertinib) include:
|
|
The most common side effects of RYBREVANT® in combination with carboplatin and pemetrexed include:
|
|
The most common side effects of RYBREVANT® when given alone:
|
|
LAZCLUZE™ may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
Your healthcare provider may temporarily stop, decrease your dose, or completely stop your treatment with RYBREVANT® or LAZCLUZE™ if you have serious side effects.
These are not all of the possible side effects of RYBREVANT® or LAZCLUZE™.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of RYBREVANT®:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
You can ask your healthcare provider or pharmacist for information about RYBREVANT® that is written for health professionals.
General information about the safe and effective use of LAZCLUZE™:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LAZCLUZE™ for a condition for which it was not prescribed. Do not give LAZCLUZE™ to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about LAZCLUZE™ that is written for health professionals.
Please read full Prescribing Information for RYBREVANT®.
Please read full Prescribing Information for LAZCLUZE™.
cp-213277v5
INDICATIONS AND DOSING
SIMPONI® is a prescription medicine for adults with:
MTX is used as directed.
For RA, PsA, and AS: SIMPONI® 50 mg is given as an injection under the skin (subcutaneous injection) once a month.
For UC: SIMPONI® begins with 3 starter injections under the skin (subcutaneous injection): Two 100-mg injections on the first day of treatment, followed by one 100-mg injection 2 weeks later. After these 3 starter injections, SIMPONI® requires one 100-mg injection every 4 weeks.
Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI® under the skin.
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
|
|
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMPONI® and during treatment with SIMPONI®. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking SIMPONI®. People who had a negative TB skin test before receiving SIMPONI® have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking SIMPONI®:
|
|
CANCER
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking other TNF blockers with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.
Some people treated with SIMPONI® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI®, tell your doctor.
USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA® (abatacept), KINERET® (anakinra), ACTEMRA® (tocilizumab), RITUXAN® (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).
HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
|
|
HEART FAILURE
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. If you develop new or worsening heart failure with SIMPONI®, you may need treatment in a hospital, and it may result in death. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.
NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.
LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
BLOOD PROBLEMS
Low blood counts have been seen with SIMPONI®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.
Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI® during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.
ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI®. Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.
Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.
PSORIASIS
New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.
Please read the full Prescribing Information and Medication Guide for SIMPONI® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
cp-51591v2
WHAT IS SIMPONI ARIA® (golimumab)?
SIMPONI ARIA® is a prescription medicine used to treat:
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
SIMPONI ARIA® (golimumab) is a prescription medicine. SIMPONI ARIA® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI ARIA® and will closely monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not receive SIMPONI ARIA® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
|
|
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMPONI ARIA® and during treatment with SIMPONI ARIA®. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking SIMPONI ARIA®. People who had a negative TB skin test before receiving SIMPONI ARIA® have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking SIMPONI ARIA®:
|
|
CANCER
Unusual cancers have been reported in children and teenage patients taking Tumor Necrosis Factor (TNF)-blocker medicines. For children and adults receiving TNF blockers, including SIMPONI ARIA®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking a TNF blocker with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.
Some people treated with SIMPONI ARIA® developed skin cancer. Tell your doctor if any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI ARIA®. Your doctor should periodically examine your skin, especially if you have a history of skin cancer.
USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA® (abatacept), KINERET® (anakinra), ACTEMRA® (tocilizumab), RITUXAN® (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People receiving SIMPONI ARIA® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).
HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are receiving TNF-blocker medicines, such as SIMPONI ARIA®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI ARIA®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
|
|
HEART FAILURE
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI ARIA®. If you develop new or worsening heart failure with SIMPONI ARIA®, you may need treatment in a hospital, and it may result in death. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.
NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI ARIA®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, or swelling of the feet, ankles or legs.
LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI ARIA®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
BLOOD PROBLEMS
Low blood counts have been seen with people using TNF blockers, including SIMPONI ARIA®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI ARIA®. Tell your doctor if you have any symptoms of an allergic reaction while receiving SIMPONI ARIA® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you have psoriasis.
Tell your doctor if you are pregnant, planning to become pregnant, are breastfeeding, or plan to breastfeed, or have a baby and received SIMPONI ARIA® during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.
COMMON SIDE EFFECTS
The most common side effects of SIMPONI ARIA® include: upper respiratory infection, abnormal liver tests, decreased blood cells that fight infection, viral infections, bronchitis, high blood pressure, and rash.
Please read the full Prescribing Information and Medication Guide for SIMPONI ARIA® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
cp-51592v3
What is SPORANOX® (itraconazole)?
SPORANOX® capsules is a prescription medicine used to treat the following fungal infections of the toenails, fingernails and other parts of the body: blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.
SPORANOX® oral solution is a prescription medicine used to treat oropharyngeal and esophageal yeast infections of the mouth, throat and food pipe (esophagus).
It is not known if SPORANOX® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPORANOX®?
SPORANOX® can cause serious side effects, including:
Heart failure: Do not take SPORANOX® if you have had heart failure, including congestive heart failure. Stop taking SPORANOX® and call your healthcare provider right away if you have any of these symptoms of congestive heart failure:
|
|
|
Heart problems and other serious medical problems: Serious medical problems that affect the heart and other parts of your body can happen if you take SPORANOX® with certain other medicines.
Do not take SPORANOX® oral solution if you also take levacetylmethadol (levomethadyl).
Do not take SPORANOX® capsules or oral solution if you also take the following medicines:
|
|
|
This is not a complete list of medicines that can interact with SPORANOX®. SPORANOX® may affect the way other medicines work, and other medicines may affect how SPORANOX® works. Ask your pharmacist for a list of medicines that interact with SPORANOX®.
Before you start taking SPORANOX®, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start any new medicine, ask your healthcare provider or pharmacist if it is safe to take it with SPORANOX®.
Liver problems. SPORANOX® can cause serious liver problems which may be severe and lead to death. Stop taking SPORANOX® and call your healthcare provider right away if you have any of these symptoms of liver problems:
|
|
|
For more information about side effects, see “What are the possible side effects of SPORANOX®?”
Do not take SPORANOX® if you:
Before taking SPORANOX®, tell your healthcare provider about all of your medical conditions, including if you have:
|
|
Taking SPORANOX® with certain medicines may affect each other. Taking SPORANOX® with other medicines can cause serious side effects.
You should not take SPORANOX® oral solution instead of SPORANOX® capsules, because it will not work the same way.
You should not take SPORANOX® capsules instead of SPORANOX® oral solution, because they will not work the same way.
What should I avoid while taking SPORANOX®?
SPORANOX® can cause dizziness and vision problems. Do not drive or operate machinery until you know how SPORANOX® affects you.
What are the possible side effects of SPORANOX®?
SPORANOX® may cause serious side effects, including:
The most common (≥ 4%) side effects for SPORANOX® capsules include: digestive system problems (such as nausea and vomiting), rash, headache, swelling. Other side effects include constipation, fever, inflammation of the pancreas, menstrual disorder, erectile dysfunction, dizziness, muscle pain, painful joints, unpleasant taste, or hair loss.
The most common (≥ 4%) side effects for SPORANOX® oral solution include: digestive system problems (such as nausea, diarrhea, vomiting), fever, stomach pain, rash, headache, cough.
These are not all the possible side effects of SPORANOX®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Keep SPORANOX® and all medicines out of the reach of children.
General information about the safe and effective use of SPORANOX®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SPORANOX® for a condition for which it was not prescribed. Do not give SPORANOX® to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information about SPORANOX® that is written for health professionals.
Please see full Product Information, including Boxed WARNING, for SPORANOX® capsules.
Please see full Product Information, including Boxed WARNING, for SPORANOX® oral solution.
cp-150959v1
Indications and Limitations of Use:
SPRAVATO® is a prescription medicine, used along with an antidepressant, taken by mouth to treat:
Limitations of Use:
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
It is not known if SPRAVATO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
|
|
Do not take SPRAVATO® if you:
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
|
|
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.
cp-361447v3
WHAT IS STELARA® (ustekinumab)?
STELARA® is a prescription medicine used to treat:
IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:
Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if you:
|
|
After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.
Cancers
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.
Posterior Reversible Encephalopathy Syndrome (PRES)
PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Lung Inflammation
Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA®.
Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed STELARA®:
Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.
Please click to read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
cp-124932v5
WHAT IS SYMTUZA®?
SYMTUZA® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children who weigh at least 88 pounds (40 kg) who:
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if SYMTUZA® is safe and effective in children weighing less than 88 pounds (40 kg).
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMTUZA®?
SYMTUZA® can cause serious side effects including:
|
|
SYMTUZA® may cause severe or life-threatening skin reactions or rashes which may sometimes require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking SYMTUZA® and call your healthcare provider right away if you develop any skin changes with symptoms below:
|
|
Who should not take SYMTUZA®?
Before taking SYMTUZA®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, topical creams, vitamins, and herbal supplements. Some medicines interact with SYMTUZA®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
HOW SHOULD I TAKE SYMTUZA®?
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SYMTUZA®?
SYMTUZA® may cause serious side effects including:
The most common side effects of SYMTUZA® are: diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas.
These are not all of the possible side effects of SYMTUZA®.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please see full Product Information, including Boxed Warning for SYMTUZA®.
cp-62077v7
What is TALVEY® (talquetamab-tgvs)?
TALVEY® is a prescription medicine to treat adults with multiple myeloma who:
TALVEY® is approved based on patient response. Data are not yet available to show if TALVEY® improves survival or symptoms.
It is not known if TALVEY® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TALVEY®?
TALVEY® may cause side effects that are serious, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and neurologic problems.
Call your healthcare provider or get medical help right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment with TALVEY®:
Cytokine Release Syndrome (CRS). CRS is common during treatment with TALVEY® and can also be serious or life-threatening. Signs and symptoms of CRS may include:
|
|
Neurologic problems. Symptoms of neurologic problems with TALVEY® may include:
|
|
TALVEY® is available only through the TECVAYLI® and TALVEY® Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.
You will receive a Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.
Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital.
See “What are the possible side effects of TALVEY®?” for more information about side effects.
Before you receive TALVEY®, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive TALVEY®?
What should I avoid while receiving TALVEY®?
Do not drive, operate heavy machinery, or do other dangerous activities during and for 48 hours after your TALVEY® “step-up dose” is completed or at any time during treatment with TALVEY®, if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness, until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.
See “What is the most important information I should know about TALVEY®?” for more information about signs and symptoms of CRS and neurologic problems.
What are the possible side effects of TALVEY®?
TALVEY® may cause serious side effects, including:
|
|
Your healthcare provider will monitor you for these symptoms and will monitor your weight during treatment with TALVEY®. Tell your healthcare provider if you lose weight during treatment with TALVEY®.
|
|
|
|
The most common side effects of TALVEY® include:
|
|
The most common severe abnormal lab test results with TALVEY® include decreased white blood cells and red blood cells. These are not all the possible side effects of TALVEY®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read full Prescribing Information, including Boxed Warning, for TALVEY®.
cp-394175v2
What is TECVAYLI® (teclistamab-cqyv)?
TECVAYLI® is a prescription medicine to treat adults with multiple myeloma who:
TECVAYLI® was approved based on patient responses. There are ongoing studies to confirm the clinical benefit of TECVAYLI®.
It is not known if TECVAYLI® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TECVAYLI®?
TECVAYLI® may cause side effects that are serious, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and neurologic problems.
Call your healthcare provider right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment with TECVAYLI®:
Cytokine Release Syndrome (CRS). Signs and symptoms of CRS may include:
|
|
Neurologic problems. Symptoms of neurologic problems with TECVAYLI® include:
|
|
|
TECVAYLI® is available only through the TECVAYLI® and TALVEY™ Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.
You will receive a Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.
Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital.
See “What are the possible side effects of TECVAYLI®?” for more information about side effects.
Before you receive TECVAYLI®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive TECVAYLI®?
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with TECVAYLI®.
What are the possible side effects of TECVAYLI®?
TECVAYLI® may cause serious side effects, including:
|
|
Your healthcare provider may temporarily or permanently stop TECVAYLI® if you have any of the side effects listed above and they are severe.
The most common side effects of TECVAYLI® include:
|
|
The most common severe abnormal lab test results with TECVAYLI® include: decreased white blood cells, red blood cells, and platelets.
These are not all the possible side effects of TECVAYLI®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI®.
cp-324738v5
INDICATIONS
TOPAMAX® is a prescription medicine used:
Important Safety Information
What is the most important information I should know about TOPAMAX®?
TOPAMAX® may cause eye problems. Serious eye problems include:
These eye problems can lead to permanent loss of vision if not treated.
You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision.
TOPAMAX® may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away.
TOPAMAX® can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPAMAX®. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
|
|
TOPAMAX® may lower bone mineral density. TOPAMAX® may decrease the density of bones when used over a long period.
TOPAMAX® may have negative effects on growth in children. TOPAMAX® may slow height increases and weight gain in children and adolescents when used over a long period
Do not stop TOPAMAX® without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
TOPAMAX® can harm your unborn baby.
Before taking TOPAMAX®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TOPAMAX® and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
How should I take TOPAMAX®?
What should I avoid while taking TOPAMAX®?
Even when taking TOPAMAX® or other antiepileptic medicines, some people with epilepsy will continue to have unpredictable seizures. Therefore, use caution and talk to your doctor before beginning any activities where loss of consciousness could result in serious danger to you or those around you (including swimming, driving a car, climbing in high places, etc.).
What are the possible side effects of TOPAMAX®?
TOPAMAX® may cause serious side effects including:
See “What is the most important information I should know about TOPAMAX®?”
Call your healthcare provider right away if you have any of the symptoms above.
The most common side effects of TOPAMAX® include:
|
|
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects of TOPAMAX®.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or by visiting http://www.fda.gov/medwatch.
You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here to read the full Prescribing Information and Medication Guide for TOPAMAX®.
cp-17014v7
WHAT IS TRACLEER®?
TRACLEER® is a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.
TRACLEER® can improve your ability to exercise and can slow the worsening of your physical condition and symptoms.
TRACLEER® lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.
TRACLEER® is only:
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TRACLEER®?
TRACLEER® is only available through the Bosentan REMS Program. Before you begin taking TRACLEER®, you must read and agree to all of the instructions in the Bosentan REMS Program.
TRACLEER® can cause serious side effects including:
Liver Damage
Serious birth defects.
TRACLEER® can cause serious birth defects if taken during pregnancy. You must not be pregnant when you start taking TRACLEER® or during TRACLEER® treatment. Serious birth defects from TRACLEER® can happen early in pregnancy. Females who are able to get pregnant must have a negative pregnancy test before starting treatment with TRACLEER®, each month during treatment with TRACLEER®, and 1 month after stopping treatment with TRACLEER®.
If you are the parent or caregiver of a female child who started taking TRACLEER® before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your healthcare provider right away if you notice that she is developing breast buds or any pubic hair. Your healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.
Who should not take TRACLEER®?
Do not take TRACLEER® if you:
What should I tell my healthcare provider before taking TRACLEER®?
TRACLEER® may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRACLEER® and other medicines may affect how each other works and cause side effects.
What are the possible side effects of TRACLEER®?
TRACLEER® can cause serious side effects, including:
The most common side effects of TRACLEER® include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRACLEER®. For more information, ask your doctor or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS about liver injury and birth defects, and Medication Guide for TRACLEER® and discuss any questions you have with your doctor.
cp-113986v5
WHAT IS TREMFYA® (guselkumab)?
TREMFYA® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis.
TREMFYA® is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA®?
TREMFYA® is a prescription medicine that may cause serious side effects, including:
|
|
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
|
|
Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.
Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:
Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See “What is the most important information I should know about TREMFYA®?”
The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.
cp-82626v7
What is UPTRAVI®?
UPTRAVI® (selexipag) is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the arteries of your lungs.
UPTRAVI® can help delay (slow down) the progression of your disease and lower your risk of being hospitalized for PAH.
It is not known if UPTRAVI® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What are the possible side effects of UPTRAVI®?
The most common side effects are:
|
|
Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of UPTRAVI®. For more information, ask your doctor or pharmacist.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Keep UPTRAVI® and all other medicines away from children.
What other medicines might interact with UPTRAVI®?
UPTRAVI® and other medicines may affect each other, causing side effects. Tell your doctor about all the medicines you are taking. Do not start any new medicine until you check with your doctor.
How should I take UPTRAVI®?
UPTRAVI® Tablets
UPTRAVI® given by intravenous (IV) injection
Please see full Prescribing Information and Patient Product Information.
cp-113991v5
What is VELETRI®?
VELETRI® is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VELETRI® may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).
Studies showing VELETRI® is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.
IMPORTANT SAFETY INFORMATION
Who should not take VELETRI®?
VELETRI® should not be used if you have heart failure due to severe left heart disease, if you develop fluid in the lungs (pulmonary edema) when starting therapy, or if you are allergic to epoprostenol.
Some medications may interact with VELETRI®. Please talk to your doctor about all of your medications.
What is the most important information I should know about?
It is important to use VELETRI® as directed by your doctor. VELETRI® should be used only with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI® with other intravenous medications. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI® to direct sunlight.
When you take epoprostenol for the first time, you must be in a setting (hospital or clinic) where you can be monitored for any serious side effects or in case of emergency. Your blood pressure and heart rate should also be monitored with any dose changes. If you are taking VELETRI®, your doctor may prescribe another kind of medicine used to prevent blood clots. It is the use of these medications concomitantly (in combination) with VELETRI® that may potentially cause an increase in the risk of bleeding.
Sudden and dramatic changes in dose may lead to unstable blood pressure, a return of pulmonary hypertension symptoms, or fatal low blood pressure (hypotension). Do not stop using VELETRI® without first talking to your doctor.
To reduce the risk of infection in the bloodstream, it is important to know how to properly care for the catheter and infusion pump.
What are the possible side effects of VELETRI®?
You may have side effects at the start of treatment or with dose increases. The most common side effects seen in at least 1% of patients were:
The most common side effects in patients with PAH due to unidentified or hereditary factors with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:
The most common side effects in patients with PAH due to connective tissue disease with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:
Talk to your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VELETRI®. For more information, ask your doctor or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information for VELETRI® and discuss any questions you have with your doctor.
cp-118962v4
What is Ventavis®?
VENTAVIS® is a prescription medicine used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VENTAVIS® may improve your ability to exercise and your symptoms for a short time by lowering your blood pressure and opening up the blood vessels in your lungs.
VENTAVIS® has not been studied in children younger than 18 years old.
IMPORTANT SAFETY INFORMATION
What should I tell my doctor before taking VENTAVIS®?:
VENTAVIS® may not be right for you.
Before taking VENTAVIS®, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
VENTAVIS® and other medicines may affect each other causing side effects. VENTAVIS® may affect the way other medicines work, and other medicines may affect how VENTAVIS® works.
Especially tell your doctor if you take:
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take VENTAVIS®?
What are the most common side effects of VENTAVIS®?
VENTAVIS® may cause side effects, including feeling dizzy, lightheaded and faint. If you have any of these side effects, you should stand up slowly when you get out of chairs or bed. Tell your doctor if your fainting gets worse during treatment with VENTAVIS®. Your doctor may need to change your dose or your treatment.
Do not drive a car or operate any tools or machines if dizziness or fainting from low blood pressure is a problem for you.
You may have trouble breathing after taking VENTAVIS® because it may cause the muscles around your airway to tighten (bronchospasm). Get emergency help right away if you have trouble breathing.
Other important side effects of VENTAVIS® include:
Talk to your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of VENTAVIS®. For more information, ask your doctor or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information and Patient Information for VENTAVIS® and discuss any questions you have with your doctor.
cp-134776v2
WHAT IS XARELTO® (rivaroxaban)?
XARELTO® is a prescription medicine used to:
XARELTO® is used with low dose aspirin to:
XARELTO® is used in children to:
XARELTO® was not studied and is not recommended in children less than 6 months of age who:
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
XARELTO® may cause serious side effects, including:
Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke. If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding:
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.
Tell your doctor right away if you have:
XARELTO® is not for use in people with artificial heart valves.
XARELTO® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing.
Do not take XARELTO® if you or your child:
Before taking XARELTO®, tell your doctor about all your medical conditions, including if you or your child:
Tell all of your doctors and dentists that you or your child are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”
HOW SHOULD I TAKE XARELTO®?
If you take XARELTO® for:
For children who take XARELTO®:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
XARELTO® may cause serious side effects:
The most common side effect of XARELTO® in adults was bleeding.
The most common side effects of XARELTO® in children include:
|
|
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please read full Prescribing Information, including Boxed Warnings, and Medication Guide for XARELTO®.
Trademarks are those of their respective owners.
cp-53637v8
INDICATION
What is YONDELIS® (trabectedin)?
YONDELIS® is a prescription medicine used to treat people with liposarcoma or leiomyosarcoma that:
It is not known if YONDELIS® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Who should not receive YONDELIS®?
You will not be given YONDELIS® if you have had a severe allergic reaction to trabectedin, the active ingredient in YONDELIS®. See the end of this leaflet for a complete list of ingredients in YONDELIS®.
What should I tell my healthcare provider before receiving YONDELIS®?
Before receiving YONDELIS®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive YONDELIS®?
What are the possible side effects of YONDELIS®?
YONDELIS® may cause serious side effects, including:
The most common side effects of YONDELIS® include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of YONDELIS®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of YONDELIS®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about YONDELIS® that is written for health professionals.
What are the ingredients in YONDELIS®?
Active ingredient: trabectedin
Inactive ingredients: potassium dihydrogen phosphate, sucrose, phosphoric acid and potassium hydroxide
Please click here to read Important Product Information.
cp-17178v3
WHAT IS ZYTIGA®?
ZYTIGA® (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA® is used to treat men with prostate cancer that has spread to other parts of the body.
It is not known if ZYTIGA® is safe and effective in females or children.
IMPORTANT SAFETY INFORMATION
Before taking ZYTIGA®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take or treatments you receive including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines.
You should not start or stop any medicine before you talk with the healthcare provider that prescribed ZYTIGA®.
Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ZYTIGA®?
What are the possible side effects of ZYTIGA®?
ZYTIGA® may cause serious side effects including:
ZYTIGA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.
THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA®.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see the full Prescribing Information and Patient Information for ZYTIGA® and discuss any questions you have with your doctor.
cp-52365v5
