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IMPORTANT SAFETY INFORMATION
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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:

  • 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 TRINZA® will harm your unborn baby
    • If you become pregnant while taking INVEGA TRINZA®, 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 TRINZA® 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 TRINZA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA TRINZA®.

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 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 TRINZA® affects you.
  • Avoid getting overheated or dehydrated.

INVEGA TRINZA® may cause serious side effects, including:

  • See “What is the most important information I should know about INVEGA TRINZA®?”
  • 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 TRINZA®. 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 TRINZA® 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
  • seizures
  • 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 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.

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