"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
(paliperidone palmitate) Extended-Release Injectable Suspension
This summary contains important information about INVEGA® SUSTENNA® for patients and caregivers and has been reviewed by the U.S. Food and Drug Administration.
Read this information carefully and talk to your doctor or treatment team if you have any questions about INVEGA® SUSTENNA® . Keep this information handy so that you can refer to it later if you have any questions. Ask your doctor or treatment team if there is any new information that you need to know about INVEGA® SUSTENNA® .
This summary does not contain all the information about INVEGA® SUSTENNA® . It does not take the place of talking with your doctor.
What is INVEGA® SUSTENNA® ?
INVEGA® SUSTENNA® can also be used to lessen the chance of your schizophrenia symptoms from coming back.
How does INVEGA® SUSTENNA® work?
Schizophrenia is believed to be caused when certain chemicals in the brain are not in balance. Not all people with schizophrenia have the same symptoms. Some of the most common symptoms of schizophrenia may include:
- Seeing, hearing, or sensing things that are not there (hallucinations)
- Believing that what other people say are not true (delusions)
- Not trusting others and feeling very suspicious (paranoia)
- Avoiding family and friends and wanting to be alone
The exact way INVEGA® SUSTENNA® works is not known. INVEGA® SUSTENNA® is thought to help restore the balance of these chemicals in the brain, and has been shown to help many people manage their symptoms of schizophrenia.
It may take some time before your symptoms of schizophrenia start to improve. Remember that INVEGA® SUSTENNA® is one part of your overall treatment plan. It is important to keep all your appointments so you can get your treatments on time and your treatment team can check your progress.
What is the most important safety information I need to know about INVEGA® SUSTENNA® ?
INVEGA® SUSTENNA® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® SUSTENNA® in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.
Who should not use INVEGA® SUSTENNA® ?
Do not take INVEGA® SUSTENNA® if you:
- Are allergic to paliperidone (INVEGA® Extended-release Tablets) or any other ingredient in INVEGA® SUSTENNA® . Ask your doctor or pharmacist for a list of these ingredients.
- Are allergic to risperidone (RISPERDAL®).
What should I tell my doctor before starting INVEGA® SUSTENNA® ?
Only your doctor can decide if INVEGA® SUSTENNA® is right for you. Before you start INVEGA® SUSTENNA® , be sure to tell your doctor or treatment team if you:
- Have a history of heart problems, any problems with the way your heart beats, or are being treated for high blood pressure.
- Have diabetes or a family history of diabetes.
- Have a history of low white blood cell counts.
- Have low levels of potassium or magnesium in your blood.
- Are being treated for seizures (fits or convulsions), have had seizures in the past, or have conditions that increase the risk of having seizures.
- Have kidney or liver problems.
- Have ever had any conditions that cause dizziness or fainting.
- Are pregnant or plan to become pregnant during treatment.
- Are breast-feeding. Women should not breast-feed a baby during treatment.
- Are taking or plan to take any prescription medicines or over-the-counter medicines such as vitamins, herbal products, or dietary supplements.
How often is INVEGA® SUSTENNA® given?
INVEGA® SUSTENNA® is a long-acting medicine that a healthcare professional will give you by injection. This means that you do not have to take this medicine every day.
When you receive your first dose of INVEGA® SUSTENNA® you will need to get a second dose one week later. After that you will only need to get a dose once a month.
Your doctor or healthcare provider will give you the injection into the upper arm or buttocks. People usually feel some pain or discomfort. In clinical studies, most patients reported the injections became less painful over time.
What if I miss an injection of INVEGA® SUSTENNA® ?
It is very important to keep all your appointments and get your injections on time. If you think you are going to miss your appointment, call your doctor or treatment team as soon as you can. Your doctor or treatment team will decide what you should do next.
What if I stop receiving INVEGA® SUSTENNA® ?
If you stop coming for your injections, your symptoms may return. You should not stop receiving injections of this medicine unless you have discussed this with your doctor.
What are the possible side effects of INVEGA® SUSTENNA® ?
As with any medicine, INVEGA® SUSTENNA® may cause side effects in some people. If you think you are developing a side effect, always discuss this with your doctor or treatment team.
Common side effects of INVEGA® SUSTENNA® include:
- Reactions at the injection site
- Feeling of inner restlessness
- Abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes
Other important safety information
Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA® SUSTENNA® and similar medicines. Call the 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® SUSTENNA® 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® SUSTENNA® 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).
High blood sugar and diabetes have been reported with INVEGA® SUSTENNA® 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.
Weight gain has been observed with INVEGA® SUSTENNA® and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.
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.
INVEGA® SUSTENNA® 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® SUSTENNA® 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® SUSTENNA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA® SUSTENNA® , 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.
Do not drink alcohol while you are taking INVEGA® SUSTENNA® .
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.
Other information to share with your doctor
Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.
How can I get the most benefit from my INVEGA® SUSTENNA® treatment?
- Remember to keep all your appointments. You need to receive your INVEGA® SUSTENNA® treatments on time and your treatment team needs to check your progress. If you are going to miss an appointment, call your doctor's office right away so you can get your next dose as soon as possible.
- Keep a list of questions. Discuss this list with your treatment team at your next visit. Your treatment team wants to know how the medicine is working so they can give you the best care possible.
- Be patient. It may take some time before your symptoms of schizophrenia start to improve.
- Follow the plan developed by you and your treatment team. Remember that INVEGA® SUSTENNA® is one part of your overall treatment plan.
Where can I find more information about INVEGA® SUSTENNA® ?
This is a summary of important information about INVEGA® SUSTENNA® . If you have any questions about this information, talk with your doctor or treatment team.
You can also visit the website at www.invegasustenna.com or call the toll-free number at 1-800-JANSSEN (1-800-526-7736) for more information about INVEGA® SUSTENNA® .
Last reviewed on RxList: 5/19/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Invega Sustenna Information
- Invega Sustenna Drug Interactions Center: paliperidone palmitate im
- Invega Sustenna Side Effects Center
- Invega Sustenna Overview including Precautions
- Invega Sustenna FDA Approved Prescribing Information including Dosage
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