INVEGA SUSTENNA^® (paliperidone palmitate) is indicated for schizophrenia and schizoaffective disorder.

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 approved for treating dementia-related psychosis.

Do not receive INVEGA SUSTENNA^® if you are allergic to paliperidone, risperidone, or any of the ingredients in INVEGA SUSTENNA^®. See 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 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 SUSTENNA^® will harm your unborn baby
• are breastfeeding or plan to breastfeed. 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 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.

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:

• 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 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. 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 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
• Call your doctor right away if you start thinking about suicide or wanting to hurt yourself

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 SUSTENNA^®. For more information, ask your healthcare provider or pharmacist.

Please see full Prescribing Information, including Boxed Warning

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

037719-150728