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Invega® and Invega Sustenna® (paliperidone and paliperidone palmitate)
All FDA warnings are at the end of this fact sheet. Please consult them before taking this medication.
Brand and Generic Names
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Brand name: Invega® tablets Invega® Sustenna® injection
Tablets: 3 mg, 6 mg, 9 mg
Injection: Extended-release injectable suspension kits: 39 mg, 78 mg, 117 mg, 156 mg, 234 mg - Generic name: Paliperidone
What is Invega® and what does it treat?
Paliperidone is a second generation antipsychotic (SGA) medication approved for the treatment of schizophrenia. Paliperidone can improve symptoms of schizophrenia such as hallucinations, delusions and disorganized thinking; in some people, improvement in social isolation, reduced speech productivity and motivation also occur.
What is the most important information I should know about Invega®?
Relapse is very common in schizophrenia and the most frequent cause is that patients stop taking their medication. Even when medication is taken exactly as prescribed, relapse may still occur for some people. Therefore it is recommended that you take your medication exactly as prescribed by your health care provider as this has been shown to decrease relapse.
- Schizophrenia requires long-term treatment. Only your health care provider can determine the length of paliperidone treatment that is right for you.
- Do not stop taking paliperidone or change your dose, without talking to your health care provider first.
- Some people may develop side effects on paliperidone such as extrapyramidal effects (restlessness, tremor, stiffness) or tardive dyskinesia (slow or jerky movements that one cannot control, often starting in the mouth with tongue rolling or chewing movements). These symptoms are likely to be less severe and occur less often than with the older antipsychotic medications (e.g., Haldol® [haloperidol], Prolixin® [fluphenazine], Thorazine® [chlorpromazine]). If you develop movements that you cannot control, call your health care provider immediately.
- Many second generation or atypical antipsychotics may cause an increase in weight, blood sugar levels or lipid levels. If you gain more than 5 percent of your original weight during therapy, talk to your health care provider about whether switching to another antipsychotic medication should be considered.
- Paliperidone treatment may be associated with strokes and/or transient ischemic attacks (TIAs) in elderly people with dementia and accompanying behavior problems. This safety concern has not been proven confidently, but there is some evidence. Talk with your health care provider if you are concerned or have questions.
- Both older first and newer second generation antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular conduction of an electrical impulse in the heart). To minimize this possibility, antipsychotic medications should be used in the smallest effective dose in situations where the benefits outweigh the risks such as schizophrenia or bipolar disorder. Often an EKG tracing may be ordered to monitor for conduction changes.
- Paliperidone treatment must be monitored by a health care provider. Be sure to keep all of your scheduled appointments so that you stay healthy while on paliperidone
- You should not take illegal drugs or drink alcohol while taking paliperidone.
Are there specific concerns about Invega®and pregnancy?
If you are planning on becoming pregnant, notify your health care provider so that he/she can best manage your medications. People living with schizophrenia who wish to become pregnant face important decisions, each with risks and benefits related to how the illness, medications and the risks to the fetus may interact. This is a complex decision as untreated schizophrenia has risks to the fetus as well as the mother. There are many dimensions to these choices, so be sure to confer with your doctor and caregivers.
Regarding breast-feeding, caution is advised since paliperidonedoes pass into breast milk.
What should I discuss with my healthcare provider before taking Invega® ?
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Symptoms of schizophrenia which are bothersome to you.
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If you had any serious side effects with other antipsychotic medications like muscle stiffness, muscle cramping, shaking, tardive dyskinesia, neuroleptic malignant syndrome, weight gain or diabetes. (For more information, see the NAMI Hearts and Minds Program.)
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If you have had an allergic reaction to paliperidone or risperidone or any other medication.
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History of heart problems, such as, heart rhythm problems, long QT syndrome or heart attacks. These illnesses may make paliperidone unsafe for you to take
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Medical problems you have, especially diabetes, high cholesterol or triglycerides, increased body weight, seizures or kidney disease or impairment.
How should I take Invega®?
- Paliperidone tablets can be taken with or without food but should be taken with a full glass of water. Do not crush, chew or break tablets since they are designed to release drug over 24 hours. The injection is either administered in the deltoid or gluteal muscle.
- Only your doctor can determine the correct dose for you. Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks. If you are receiving the injection, your health care provider will also need to start at a lower dose and gradually increase the dose.
- Use a calendar or pill box to help you remember to take your medication. Or, have a family member or friend remind you or check in with you to be sure you are taking your medication.
What happens if I miss a dose of Invega®?
If you miss a dose of paliperidone, take it as soon as you remember it, if it is not too close to when your next dose is due—discuss this with your health care provider. Do not double your next dose or take more than what is prescribed. If it has been longer than six weeks since your last injection, your health care provider may give extra injections.
What should I avoid while taking Invega®?
- Paliperidone may cause dizziness or drowsiness, especially when first starting the medication. Make sure you know how you react to the medication before you drive, operate machinery or do other activities that may be dangerous if you are not alert.
- Avoid drinking alcohol or using illegal drugs while taking paliperidone.
What happens if I overdose with Invega®?
If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center at 1 (800) 222-1222.
What are the possible side effects of Invega®?
Side effects that are usually relatively minor include low blood pressure or dizziness, especially when standing up suddenly; sleepiness; constipation; weight gain; sexual dysfunction; and fatigue. Some of these problems may be reduced by increasing the dose slowly. Patients who already have low blood pressure, have kidney or liver impairment, are elderly or are in a weakened condition may require close monitoring and even more gradual dose adjustment.
Paliperidone may increase the blood levels of a hormone called prolactin. Side effects of increased prolactin levels include females losing their period, production of breast milk and males losing their sex drive or possibly experiencing erectile problems. Long term (months or years) of elevated prolactin can lead to softer bones, osteoporosis or increased risk of bone fractures. Contact your doctor if these symptoms occur or to discuss any concerns.
What are the more serious side effects of antipsychotics?
- With newer second generation antipsychotics (SGA), more commonly seen are diabetes/weight gain/increased cholesterol and triglycerides as noted in stronger warnings mandated by the FDA in individual drug labeling. For the relative risk of weight gain and diabetes seen with the various drugs, see Table 2 in the Consensus Conference on Antipsychotic Drugs. These guidelines make recommendations for the monitoring of cardiac risk factors while on atypical antipsychotics.
Please also consult the Metabolic and Diabetes tab on the Hearts and Minds section for the current monitoring information regarding triglycerides, cholesterol, fasting blood glucose, etc. to help plan preventative interventions.
- Less commonly seen, but important, is the early death/dementia risk as noted in the FDA boxed warning. In some clinical trials, it was determined that elderly people developed strokes at a higher rate than those on placebo medication (sugar pill). The SGA group has less tardive dyskinesia (TD), neuroleptic malignant syndrome, seizures and changes in heart rhythm than FGA drugs but not zero.
What do I do about the more serious risks?
Please let your doctors know if you have any of these medical conditions prior to starting paliperidone.
It is important to be aware of prevention with attention to nutrition, exercise and reducing your plate size (because the medications may reduce your ability to feel full after eating). For more ideas, see the NAMI Hearts & Minds Program.
Also, obtain Abnormal Involuntary Movement testing (AIMS) to monitor for TD. While it is less common with newer SGA, it has been reported. If you are taking an older FGA, then regular AIMS testing is needed for monitoring, so you can make good choices about the use of the drug when weighing the risks and benefits.
Are there any risks for taking Invega® for long periods of time?
Tardive dyskinesia (TD) is a side effect that develops with prolonged use of antipsychotics. Medications such as paliperidone have been shown to have a much lower risk of TD compared to older antipsychotics, such as Haldol® (haloperidol). Should you develop symptoms of TD, such as grimacing, sucking and smacking of lips and other movements that you cannot control, contact your health care provider immediately.
No one can predict how much weight a person will gain on any medicine, but an approach that includes exercise and diet and monitoring for weight gain and diabetes is recommended.
What other drugs may interact with Invega® ?
Paliperidone may cause changes to your heart rhythm. If you are currently taking medications for heart rhythm problems such as amiodarone (Cordarone®, Pacerone®), disopyramide (Norpace®), sotalol (Betapace®) and others so talk with your doctor prior to starting paliperidone.
Paliperidone may potentially lower one’s blood pressure, so caution needs to be used with other agents that may decrease your blood pressure.
Paliperidone may block the effects of agents used to treat Parkinson’s disease such as levodopa (Sinemet®), bromocriptine, pramipexole (Mirapex®), ropinirole (Requip®) and others.
How long does it take for Invega®to work?
Paliperidone rebalances dopamine and serotonin to improve thinking, mood and behavior. Improvement of some symptoms may be noticed in some patients within a few weeks. The full benefit of paliperidone may not be seen for six to 12 weeks or longer.
FDA ALERT [06/06/2008]
Both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. |
Updated by Elizabeth A. Eichel-Bato, Pharm.D., BCPP, BCPS
(December 2010)
NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.
Reviewed by Dr. Ken Duckworth, NAMI Medical Director
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