Janssen CarePath provides the additional support you may need to help you get started with INVEGA SUSTENNA® treatment, once you and your doctor have decided that INVEGA SUSTENNA® is right for you. Janssen CarePath will work closely with you and your doctor to provide the support you need.
Janssen CarePath can:
- Review your health plan benefits to help answer questions you may have about insurance coverage for INVEGA SUSTENNA®
- Identify options that may help make INVEGA SUSTENNA® more affordable, if needed
- Provide treatment education support. We also invite you to learn more at InvegaSustenna.com
To request a benefits investigation to learn about your insurance coverage, or if you have any questions, please call Janssen CarePath at 877-524-3579, Monday–Friday, 8:00 AM to 8:00 PM ET.
Alternate Site of Care Options for Injection
Janssen CarePath supports patients who need an injection appointment. If requested by your doctor, Janssen CarePath can identify a place for your injection and schedule an injection appointment with a site of care in the JANSSEN CONNECT® Network (if available in your geographic area).
If Your Health Plan Does Not Approve INVEGA SUSTENNA® Treatment
Sometimes you may not be able to obtain the medication that your doctor has prescribed for you. For example, your health plan might not cover the medication because it is not on the plan’s drug list (formulary) or the cost is higher than you think you should have to pay. In these situations, you and your doctor have the right to ask the health plan to explain its decision and to consider making the medication available to you as an exception to its policies.
If you have any questions, please call Janssen CarePath at 877-524-3579, Monday–Friday, 8:00 AM to 8:00 PM ET.
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:
- have had Neuroleptic Malignant Syndrome (NMS)
- have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
- have or have had low levels of potassium or magnesium in your blood
- have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- have or have had kidney or liver problems
- have diabetes or have a family history of diabetes
- have had a low white blood cell count
- have had problems with dizziness or fainting or are being treated for high blood pressure
- have or have had seizures or epilepsy
- have any other medical conditions
are pregnant or plan to become pregnant. It is not known if INVEGA SUSTENNA® will harm your unborn baby
- If you become pregnant while taking INVEGA SUSTENNA®, 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 INVEGA SUSTENNA® 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.
- are breastfeeding or plan to breastfeed. INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA SUSTENNA®.
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 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 SUSTENNA® affects you
- avoid getting overheated or dehydrated
INVEGA SUSTENNA® may cause serious side effects, including:
- See “What is the most important information I should know about INVEGA SUSTENNA®?”
- stroke in elderly people (cerebrovascular problems) that can lead to death
- Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA SUSTENNA®. 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; changes in your breathing, heartbeat, and blood pressure
- problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out; dizziness; or feeling as if your heart is pounding or missing beats
- uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain
- low blood pressure and fainting
- changes in your blood cell counts
- high level of prolactin in your blood (hyperprolactinemia). INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection
- problems thinking clearly and moving your body
- difficulty swallowing that can cause food or liquid to get into your lungs
- prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours
- problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration
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.