Invega® (paliperidone)
FDA ALERT Invega® is a type of medicine called an atypical antipsychotic. FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. This is not an approved use
Brand and Generic Names
Extended release tablets: 3 mg, 6 mg, 9 mg
What is Invega® and what does it treat?
Paliperidone is an antipsychotic 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.
Paliperidone is an active metabolite (or by-product) of risperidone (Risperdal®) is also known as 9-hydroxy-risperidone. Paliperidone is in a long release capsule using a technology known as OROS—after it has been swallowed, the medication is steadily released into the body over a 24 hour period. The tablet shell and core will not dissolve when it is in the intestinal tract—it is passed out of the body in the stool.
While not approved by the FDA for other uses, paliperidone may be used alone or with other medications to treat bipolar disorder or symptoms such as agitation or other behavior problems in older persons with memory loss or people with developmental disabilities, children with mental illnesses like schizophrenia or bipolar disorder, or depression. It may also be used for long-term management of bipolar disorder or Tourette’s disorder.
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 healthcare provider as this has been shown to decrease relapse.
Also:
- Schizophrenia requires long-term treatment. Only your healthcare 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 healthcare 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 healthcare provider immediately.
- 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.
- Paliperidone treatment must be monitored by a healthcare 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.
What should I discuss with my healthcare provider before taking Invega® ?
- Symptoms of schizophrenia that are bothersome to you.
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If you had any serious side effects to other antipsychotic medications like muscle stiffness, muscle cramping, shaking, tardive dyskinesia, neuroleptic malignant syndrome, weight gain, or diabetes, tell your healthcare provider.
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If you have had an allergic reaction to risperidone (Risperdal®) 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.
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If you have pre-existing gastrointestinal narrowing (esophageal motility disorders, small bowel inflammatory disease, short gut syndrome, stricture) or blockage of the gastrointestinal tract (esophagus, stomach or small and large intestine) make sure your provider knows this information. The tablet can get stuck in patients with narrowing or blockage of the gastrointestinal tract.
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If you have trouble swallowing, this may not be the best medication for you to take. Because of the special release technology used to make this pill, it needs to be swallowed whole.
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Medications you have taken in the past for schizophrenia. It would be helpful for your provider to know which medications were effective and which were not.
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All other medications you are currently taking.
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If you smoke cigarettes, use illegal drugs, or drink alcohol.
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Any medication allergies you have.
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If you are pregnant, plan to get pregnant, or are breast feeding.
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Tell your doctor if you have thoughts of suicide.
How should I take Invega®?
- Paliperidone is usually taken by mouth once daily in the morning. The tablet is made from a special technology called OROS™ which releases the drug steadily over a 24 hour period.
- Paliperidone can be taken with or without food but should be taken with a full glass of water.
- Do not chew, crush, or break paliperidone. Breaking the pill will cause much of the medication to be released at one time in your body putting you at risk for side effects.
- Only your doctor can determine the correct dose for you. Typically patients begin at a low dose of medicine (3 mg or 6 mg) and the dose is increased slowly over several weeks.
- 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.
What should I avoid while taking Invega®?
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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.
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Avoid drinking alcohol or using illegal drugs while taking paliperidone
What are the possible side effects of Invega®?
Paliperidone’s more common side effects are restlessness and extrapyramidal symptoms (muscle stiffness, tremors, and body shakes). At higher doses, extrapyramidal side effects often increase. Cogentin® (benztropine) or Benadryl® (diphenhydramine) can be prescribed to reduce or eliminate stiffness and tremors.
Other 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.
More serious side effects include weight gain, diabetes, high cholesterol and triglycerides, neuroleptic malignant syndrome, seizures and changes in heart rhythm. Please let your doctor know if you have any of these medical conditions prior to starting paliperidone
Patients taking paliperidone may see the tablet shell in their stool. Although you may see the tablet in your stool, this is normal and the medication has been absorbed and distributed throughout your body.
In some clinical trials, it was determined that elderly people treated with paliperidone developed strokes at a higher rate than those on placebo medication (sugar pill). It is not known at this time if paliperidone causes stroke.
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 healthcare provider immediately.
Paliperidone is thought to have a lower risk of weight gain than some of the other atypical antipsychotics. 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 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, 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 6-12 weeks or longer.
How long does one have to continue taking Invega®?
Patients with schizophrenia or other psychiatric disorders may require long-term treatment with paliperidone. Patients should never stop taking paliperidone without first talking with their doctor.
Prepared by Karen Moeller, Pharm.D., BCPP
(February 2008)
NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.
Reviewed by Dr. Ken Duckworth, NAMI Medical Director
For further information. Please contact the pharmaceutical company listed below.
Free or low-cost medications provided by pharmaceutical companies
Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.
Invega Rx Assistance Program: http://www.access2wellness.com/a2w/index.html
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