What is PALIPERIDONE PALMITATE used for?

PALIPERIDONE PALMITATE (brand name INVEGA SUSTENNA) is a Atypical Antipsychotic indicated for See full prescribing information.

What are the most common side effects of PALIPERIDONE PALMITATE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for PALIPERIDONE PALMITATE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is PALIPERIDONE PALMITATE the same as INVEGA SUSTENNA?

INVEGA SUSTENNA is a brand name for PALIPERIDONE PALMITATE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

PALIPERIDONE PALMITATE

Q: How does PALIPERIDONE PALMITATE work?

PALIPERIDONE PALMITATE works through the following mechanism: 12.1 Mechanism of Action Paliperidone palmitate is hydrolyzed to paliperidone [see Clinical Pharmacology (12.3) ] . Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism..

Atypical Antipsychotic

Brand names: INVEGA SUSTENNA

Intramuscular

Mechanism of Action

12.1 Mechanism of Action Paliperidone palmitate is hydrolyzed to paliperidone [see Clinical Pharmacology (12.3) ] . Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS INVEGA SUSTENNA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone
• or to any of the excipients in the INVEGA SUSTENNA formulation. Hypersensitivity reactions
• including anaphylactic reactions and angioedema
• have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone palmitate is converted to paliperidone
• which is a metabolite of risperidone. Known hypersensitivity to paliperidone

FDA Warnings

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e
3 ) QT Prolongation: Avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval
6 ) Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope
1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death

Known Side Effects

3 documented side effects by frequency

Drug Not Working

>10%

Weight Gain

1-10%

Condition Worsened

0.1-1%

Community Discussions

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Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → PALIPERIDONE PALMITATE openFDA label JSON → PALIPERIDONE PALMITATE FAERS adverse-event reports → PALIPERIDONE PALMITATE ClinicalTrials.gov → completed Phase 2+ trials of PALIPERIDONE PALMITATE

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Formulations

Dosage Forms

Tablet

Route

Intramuscular