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
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.
This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. The material on this site is intended only as informational or as an educational aid and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.
This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.
Capitalized product names are trademarks of Janssen Pharmaceuticals, Inc.