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paliperidone

Pronunciation

Generic Name: paliperidone (oral) (pal ee PER i done)
Brand Name: Invega

What is paliperidone?

Paliperidone is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Paliperidone is used to treat schizophrenia in adults and teenagers who are at least 12 years old.

Paliperidone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about paliperidone?

Paliperidone is not approved for use in psychotic conditions related to dementia. Paliperidone may increase the risk of death in older adults with dementia-related conditions.

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What should I discuss with my healthcare provider before taking paliperidone?

You should not use this medicine if you are allergic to paliperidone or risperidone (Risperdal).

Paliperidone is not approved for use in psychotic conditions related to dementia. Paliperidone may increase the risk of death in older adults with dementia-related conditions.

Long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you take paliperidone, the more likely you are to develop this movement disorder. The risk of this side effect is higher in women and older adults.

To make sure paliperidone is safe for you, tell your doctor if you have:

  • a history of heart disease or heart rhythm disorder;

  • a personal or family history of Long QT syndrome;

  • a history of low white blood cell (WBC) counts;

  • high or low blood pressure;

  • a stomach or intestinal disorder;

  • liver or kidney disease;

  • seizures or epilepsy;

  • a history of breast cancer;

  • a history of suicidal thoughts;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • diabetes (paliperidone may raise your blood sugar); or

  • an electrolyte imbalance, such as low potassium or magnesium levels in your blood.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking paliperidone, do not stop taking it without your doctor's advice.

Paliperidone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Older adults may be more sensitive to the effects of this medicine.

How should I take paliperidone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Paliperidone can be taken with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Use paliperidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Your doctor will need to check your progress while you are using paliperidone.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking paliperidone?

While you are taking paliperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking paliperidone.

Paliperidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol while taking paliperidone.

Paliperidone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using paliperidone and call your doctor at once if you have any of these signs of a serious movement disorder:

  • tremors or shaking in your arms or legs;

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

  • any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

  • headache with chest pain, pounding heartbeats or fluttering in your chest;

  • a light-headed feeling, like you might pass out;

  • thoughts about suicide or hurting yourself;

  • breast swelling (in women or men), nipple discharge;

  • changes in menstrual periods;

  • penis erection that is painful or lasts 4 hours or longer;

  • sudden weakness or ill feeling, fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

  • drowsiness;

  • agitation, feeling restless;

  • tremors or shaking;

  • uncontrolled muscle movements, problems with balance or walking;

  • upset stomach, constipation;

  • neck stiffness;

  • weight gain;

  • fast heart rate; or

  • sore throat, sinus pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Paliperidone dosing information

Usual Adult Dose for Schizophrenia:

EXTENDED-RELEASE TABLETS:
Recommended dose: 6 mg orally once a day
Dose range: 3 to 12 mg per day; dose increases may be made in increments of 3 mg per day and should occur at intervals of more than 5 days.
Maximum dose: 12 mg per day

Comment: Initial dose titration is not required; greater effects may be seen with higher doses, however this must be weighed against dose-related increases in adverse events; doses above 6 mg per day have not been systematically studied for additional benefit.

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:
-For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension
-Dosing in the US and Canada is the same; however, paliperidone extended-release injectable suspension is dosed as the salt (paliperidone palmitate) in the US and as the base (paliperidone) in Canada:

US dosing: (Based on paliperidone palmitate):
Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later; administer IM into deltoid muscle
Maintenance dose: 117 mg IM monthly; administer into deltoid or gluteal muscle
Dose range: 39 to 234 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Canada dosing: (Based on paliperidone):
Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later; administer IM into deltoid muscle
Maintenance dose: 75 mg IM monthly; administer into deltoid or gluteal muscle
Dose range: 50 to 150 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Comments:
-The dosing window for maintenance doses is 7 days before or after monthly time point; if a dose is missed during initial titration or maintenance dosing, see dosage adjustment section for guidance.

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:
-Patients should be adequately treated for at least 4 months with the 1-month extended-release suspension prior to starting on the 3-month extended-release formulation.
-In order to establish a consistent maintenance dose, it is recommended that the last 2 doses of the 1-month extended-release suspension be of the same dosage strength.
-Initiate with the 3-month extended release injection when the next 1-month extended-release suspension dose is scheduled (up to 7-days before or after the monthly dose is scheduled).

Initial dose will be based on the 1-month extended-release suspension (note it will be 3.5-fold higher than monthly dose)
--Initiate with 273 mg IM every 3 months if the last dose of the 1-month extended-release suspension was 78 mg
--Initiate with 410 mg IM every 3 months if the last dose of the 1-month extended-release suspension was 117 mg
--Initiate with 546 mg IM every 3 months if the last dose of the 1-month extended-release suspension was 156 mg
--Initiate with 819 mg IM every 3 months if the last dose of the 1-month extended-release suspension was 234 mg
Dose adjustments may be made every 3 months in increments within the range of 273 mg to 819 mg based on efficacy and tolerability; due to long-acting nature of the formulation, it may take several months for the patient's response to be apparent.

Comments:
-The dosing window is 2 weeks before or after the 3-month time point; missed doses should be avoided. If a dose is missed, see dosage adjustment section for guidance.
-Conversion from 39 mg IM once-monthly was not studied.

Use: For the treatment of schizophrenia.

Usual Adult Dose for Schizoaffective Disorder:

Recommended dose: 6 mg orally once a day
Dose range: 3 to 12 mg per day; dose increases may be made in increments of 3 mg per day and should occur at intervals of more than 4 days.
Maximum dose: 12 mg per day

Comment: Initial dose titration is not required; greater effects may be seen with higher doses, however this must be weighed against dose-related increases in adverse events; doses above 6 mg per day have not been systematically studied for additional benefit.

Use: Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Usual Pediatric Dose for Schizophrenia:

12 to 17 years old:
Recommended dose: 3 mg orally once a day
Dose range: 3 to 12 mg per day; dose increases may be made in increments of 3 mg per day and should occur at intervals of more than 5 days.
Maximum dose: 12 mg per day

Comments: Initial dose titration is not required; in the adolescent schizophrenia trials, higher doses (6 mg per day in patients weighing less than 51 kg; 12 mg per day in patients weighing 51 kg or more) did not demonstrate greater efficacy, while adverse events were dose-related.

Use: Treatment of schizophrenia

What other drugs will affect paliperidone?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking paliperidone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with paliperidone, especially:

  • carbamazepine;

  • citalopram;

  • lumefantrine;

  • rifampin;

  • St. John's wort;

  • cancer medicine--arsenic trioxide, toremifene, vandetanib;

  • heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol; or

  • other medicines to treat mental illness--iloperidone, pimozide, ziprasidone, others.

This list is not complete. Other drugs may interact with paliperidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about paliperidone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.02. Revision Date: 2014-07-14, 11:25:42 PM.

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