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 zavegepant are advised to avoid it.
Warnings
Hypersensitivity reactions: these reactions include facial swelling and urticaria, which have occurred in patients treated with zavegepant in clinical studies. Discontinue zavegepant and initiate appropriate therapy, if a hypersensitivity reaction occurs.
Adverse Reactions
Clinical Trials Experience
The safety of zavegepant 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 zavegepant nasal spray (N=1023) or placebo (N=1056).
It showed that 18% of patients receiving zavegepant 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 zavegepant had Hypersensitivity reaction, including facial swelling and urticaria.
Postmarketing Experience
There is limited information regarding Zavegepant Postmarketing Experience in the drug label.
Drug Interactions
1. Avoid concomitant administration of ZAVZPRET with drugs that inhibit OATP1B3 or NTCP transporters. Because the concomitant administration of ZAVZPRET with inhibitors of the organic anion transporting polypeptide 1B3 (OATP1B3) or sodium taurocholate co-transporting polypeptide (NTCP) transporters may result in a significant increase in zavegepant exposure.
2. Avoid concomitant administration of ZAVZPRET with drugs that induce OATP1B3 or NTCP transporters as the concomitant administration of ZAVZPRET with inducers of OATP1B3 or NTCP transporters may result in a decrease in zavegepant exposure.
3. Intranasal decongestants are not used along with zavegepant because the concomitant administration of zavegepant with intranasal decongestants may decrease the absorption of zavegepant. However, intranasal decongestants should be administered at least 1 hour after zavegepant administration when concomitant use is unavoidable.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): B
No adverse developmental effects were observed following subcutaneous administration of zavegepant to pregnant animals
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
Avoid use of zavegepant in patients with severe hepatic impairment, although no studies have been done in patients with severe hepatic impairment. However, no dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh Class B and C).
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
The recommended dose of ZAVZPRET is 10 mg given as a single spray in one nostril, as needed.
The maximum dose that may be given in a 24-hour period is 10 mg (one spray).
It is never used to prevent migraine.
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
Avoid use of zavegepant in patients with severe hepatic impairment, although no studies have been done in patients with severe hepatic impairment. However, no dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh Class B and C).
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
Peak plasma concentration of zavegepant was observed at approximately 30 minutes after a single 10 mg dose of the nasal spray and the absolute bioavailability is approximately 5%.
The mean apparent volume of distribution is approximately 1774 L with plasma protein binding of zavegepant is approximately 90%.
Zavegepant is primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6, with no metabolites found in the plasma.
The effective half-life of zavegepant following a 10 mg dose of the nasal spray is 6.55 hours with most of Zavegepant being excreted via the biliary/fecal route, while the renal route is a minor route of elimination.
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
Zavegepant nasal spray (NDC 0069-3500-01) contains 10 mg zavegepant and is supplied as a ready-to-use, unit-dose disposable device.
Storage
Zavegepant is stored at controlled room temperature, 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F).
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
Zavzpret
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.