Pimavanserin
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
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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.
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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
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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.
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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.