PALIPERIDONE PALMITATE

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%

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Formulations

Dosage Forms

Tablet

Route

Intramuscular