Zavegepant
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. that is FDA approved for the treatment of acute migraine with or without aura in adults.. Common adverse reactions include taste disorders, nausea, nasal discomfort, and vomiting.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dose is 10 mg given intranasally as a single spray in one nostril, as needed, with the maximum dosage at 10mg in 24 hours.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Zavegepant FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Patients with history of hypersensitivity reaction to zavegepant or to any of the components of ZAVZPRET are advised to avoid it.
Warnings
Hypersensitivity reactions: these reactions include facial swelling and urticaria, which have occurred in patients treated with ZAVZPRET in clinical studies. Discontinue ZAVZPRET and initiate appropriate therapy, if a hypersensitivity reaction occurs.
Adverse Reactions
Clinical Trials Experience
The safety of ZAVZPRET for the acute treatment of migraine in adults was evaluated in two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) in patients with migraine who received one 10 mg dose of ZAVZPRET nasal spray (N=1023) or placebo (N=1056).
It showed that 18% of patients receiving ZAVPRET had adverse effect of taste disorder, followed by 4% having nausea, 3%nasaldiscomfort and 2% had vomiting compared to those who recieved the placebo. Furthermore, less than 1% of patients treated with ZAVZPRET had Hypersensitivity reaction, including facial swelling and urticaria.
Postmarketing Experience
There is limited information regarding Zavegepant Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Zavegepant Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Zavegepant in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zavegepant in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Zavegepant during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Zavegepant in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Zavegepant in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Zavegepant in geriatric settings.
Gender
There is no FDA guidance on the use of Zavegepant with respect to specific gender populations.
Race
There is no FDA guidance on the use of Zavegepant with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Zavegepant in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Zavegepant in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Zavegepant in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Zavegepant in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Zavegepant Administration in the drug label.
Monitoring
There is limited information regarding Zavegepant Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Zavegepant and IV administrations.
Overdosage
There is limited information regarding Zavegepant 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 Zavegepant Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Zavegepant Mechanism of Action in the drug label.
Structure
There is limited information regarding Zavegepant Structure in the drug label.
Pharmacodynamics
There is limited information regarding Zavegepant Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Zavegepant Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Zavegepant Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Zavegepant Clinical Studies in the drug label.
How Supplied
There is limited information regarding Zavegepant How Supplied in the drug label.
Storage
There is limited information regarding Zavegepant 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 Zavegepant Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Zavegepant 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 Zavegepant Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Zavegepant 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.