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 approved 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 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® 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
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.
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 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:
-
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
-
Call your doctor right away if you start thinking about suicide or wanting to hurt yourself
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®.
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 provider for information about INVEGA TRINZA® that is written for health professionals.
This Patient Information leaflet summarizes the most important information about INVEGA TRINZA®. 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.InvegaTrinzahcp.com or call 1‑800-526-7736.
Please see full Prescribing Information including Boxed WARNING for INVEGA TRINZA®.
Please see full Prescribing Information including Boxed WARNING for INVEGA SUSTENNA®.
045411-170321
IMPORTANT SAFETY INFORMATION and INDICATION for INVEGA® (paliperidone)
INVEGA® (paliperidone) is used for the short-term treatment of schizoaffective disorder in adults and for the treatment of schizophrenia in adults and in adolescents (12-17 years of age).
INVEGA® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.
Do not receive INVEGA® if you are allergic to paliperidone, risperidone, or any of the ingredients in INVEGA®
Neuroleptic Malignant Syndrome (NMS) is a rare but serious side effect that could be fatal and has been reported with INVEGA® and similar medicines. Call your doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.
Tardive Dyskinesia (TD) is a rare but serious and sometimes permanent side effect reported with INVEGA® and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received. This condition can also develop after a short period of treatment at low doses, but this is less common. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped.
One risk of INVEGA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you’re having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).
Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:
High blood sugar and diabetes have been reported with INVEGA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.
Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.
Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment. For adolescent patients (12-17 years of age) weight gain should be assessed against that expected with normal growth.
People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach, or small or large intestine) should talk to their healthcare professional before taking INVEGA®.
Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the 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.
INVEGA® and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.
INVEGA® and similar medicines can raise the blood levels of a hormone called prolactin, and blood levels of prolactin remain high with continued use. This may result in some side effects, including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
INVEGA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.
INVEGA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA®, be careful driving a car, operating machines, or doing things that require you to be alert.
This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.
INVEGA® should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.
Do not drink alcohol while you are taking INVEGA®.
The most common side effects that occurred with INVEGA® in the treatment of schizophrenia in adults were: abnormal muscle movements (including tremor [shaking]), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes); feeling of inner restlessness or needing to be constantly moving; and fast heartbeat. The most common side effects that occurred with INVEGA® in the treatment of schizophrenia in adolescents were: drowsiness, abnormal muscle movement (including a feeling of inner restlessness or needing to be constantly moving, tremor [shaking], involuntary muscle contractions, stiff muscles making your movements jerky); feeling of inner restlessness or needing to be constantly moving; fast heartbeat, and anxiety (nervousness). The most common side effects that occurred with INVEGA® in the treatment of schizoaffective disorder in adults were: abnormal muscle movements (including tremor [shaking]), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), sleepiness, heartburn, constipation, weight increase, and sore throat.
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
If you have any questions about INVEGA® or your therapy, talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information including Boxed WARNING for INVEGA®
048982-170321
