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IMPORTANT SAFETY INFORMATION and INDICATION for INVEGA TRINZA^® (paliperidone palmitate) and INVEGA SUSTENNA^® (paliperidone palmitate)

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.

INVEGA SUSTENNA^® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA^® is used to treat schizophrenia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about INVEGA TRINZA^® and INVEGA SUSTENNA^® ?
INVEGA TRINZA^® and 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 TRINZA^® and INVEGA SUSTENNA^® are not for treating dementia-related psychosis.

Do not receive INVEGA TRINZA^® or INVEGA SUSTENNA^® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA^® or INVEGA SUSTENNA^® . See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA TRINZA^® and INVEGA SUSTENNA^® ingredients

Before you receive INVEGA TRINZA^® or INVEGA SUSTENNA^®, tell your healthcare provider 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^® or INVEGA SUSTENNA^® will harm your unborn baby
- If you become pregnant while taking INVEGA TRINZA^®, talk to your healthcare provider 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^® or INVEGA SUSTENNA^®may have withdrawal symptoms or other symptoms such as tremors, muscle spasms, abnormal movement of arms and legs, and twitching of eyes.

are breastfeeding or plan to breastfeed. INVEGA TRINZA^® and INVEGA SUSTENNA^® can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will receive INVEGA TRINZA^® or INVEGA SUSTENNA^® or breastfeed. You should not do both.

Tell your healthcare provider 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 provider 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 provider for the potential risk of falls.

What should I avoid while receiving INVEGA TRINZA^® or INVEGA SUSTENNA^®?

INVEGA TRINZA^® and 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 TRINZA^® or INVEGA SUSTENNA^® affects you
avoid getting overheated or dehydrated

INVEGA TRINZA^® and INVEGA SUSTENNA^® may cause serious side effects, including:

See “What is the most important information I should know about INVEGA TRINZA^® or 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 TRINZA^® or INVEGA SUSTENNA^®. 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; changes in your breathing, heartbeat, and blood pressure
problems with your heartbeat. These heart problems can cause death. Call your healthcare provider 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^® and 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
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 provider 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.

The most common side effects of INVEGA SUSTENNA^® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner 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 provider 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^® or INVEGA SUSTENNA^®. For more information, ask your healthcare provider 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^® or INVEGA SUSTENNA^®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA TRINZA^® or INVEGA SUSTENNA^® for a condition for which it was not prescribed. Do not give INVEGA TRINZA^® or 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 provider for information about INVEGA TRINZA^® or INVEGA SUSTENNA^® that is written for healthcare professionals.

This Patient Information leaflet summarizes the most important information about INVEGA TRINZA^® and INVEGA SUSTENNA^® . If you would like more information, talk with your healthcare provider.

You can ask your healthcare provider or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegatrinza.com or www.invegasustenna.com or call 1-800-526-7736.

045411-170710