Pimavanserin

Pimavanserin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino, M.D. [2]

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Black Box Warning

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete Boxed Warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Pimavanserin is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.

Overview

Pimavanserin is an atypical antipsychotic that is FDA approved for the treatment of patients with hallucinations and delusions associated with Parkinson's disease psychosis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include peripheral edema and confusional state (≥5% and twice the rate of placebo)..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Pimavanserin FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Pimavanserin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Pimavanserin Contraindications in the drug label.

Warnings

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete Boxed Warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Pimavanserin is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.

There is limited information regarding Pimavanserin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Pimavanserin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Pimavanserin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Pimavanserin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Pimavanserin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pimavanserin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pimavanserin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pimavanserin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Pimavanserin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Pimavanserin in geriatric settings.

Gender

There is no FDA guidance on the use of Pimavanserin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pimavanserin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pimavanserin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pimavanserin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pimavanserin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pimavanserin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Pimavanserin Administration in the drug label.

Monitoring

There is limited information regarding Pimavanserin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Pimavanserin and IV administrations.

Overdosage

There is limited information regarding Pimavanserin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Pimavanserin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Pimavanserin Mechanism of Action in the drug label.

Structure

There is limited information regarding Pimavanserin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pimavanserin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Pimavanserin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Pimavanserin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Pimavanserin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Pimavanserin How Supplied in the drug label.

Storage

There is limited information regarding Pimavanserin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Pimavanserin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Pimavanserin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Pimavanserin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Pimavanserin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.