NUPLAZID™ (pimavanserin) Tablets Prescribing Information

Clinical pharmacology

BOXED WARNING:
WARNING: 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. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis

Initial U.S. Approval: 2016

Mechanism of Action:
The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinson's disease psychosis is unknown. However, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors.

Indications and usage

INDICATIONS AND USAGE:
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

Dosage and administration

Drug UPDATES: NUPLAZID™ (pimavanserin) tablets
[Drug information / PDF]
Package insert - Dosing: Click (+) next to Dosage and Administration section (drug info link)

DOSAGE AND ADMINISTRATION
Recommended dose is 34 mg, taken orally as two 17 mg tablets once daily, without titration.
Can be taken with or without food.

How supplied

HOW SUPPLIED:
Tablets: 17 mg.

Reference

Drug UPDATES: NUPLAZID™ (pimavanserin) tablets
[Drug information / PDF]
Package insert

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.