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ZAVZPRET™ ([zavegepant] nasal spray)
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ZAVZPRET™ Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
ZAVZPRET is not indicated for the preventive...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
The recommended dose of ZAVZPRET is 10 mg given as a single spray in one nostril, as needed.
The maximum dose...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Nasal spray: 10 mg of zavegepant per device. Each unit-dose nasal spray device delivers a single spray containing 10 mg of zavegepant.
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Contraindications
4 CONTRAINDICATIONS
ZAVZPRET is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or any of the components of ZAVZPRET [see Warnings and Precautions (...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including facial swelling and urticaria, have occurred in patients treated with...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- •
- Hypersensitivity Reactions [see...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 OATP1B3 or NTCP Inhibitors
Concomitant administration of ZAVZPRET with inhibitors of the organic anion transporting polypeptide 1B3 (OATP1B3)...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate data on the developmental risk associated with the...
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Description
11 DESCRIPTION
ZAVZPRET (zavegepant) nasal spray contains zavegepant hydrochloride, a calcitonin gene-related peptide receptor antagonist. Zavegepant hydrochloride is described chemically as (R)-N-(3-(7-methyl-1H-indazol-5-...
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Clinical Pharmacology
...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Intranasal administration of...
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Clinical Studies
14 CLINICAL STUDIES
The efficacy of ZAVZPRET for the acute treatment of migraine with or without aura in adults was demonstrated in two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2). In both...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ZAVZPRET nasal spray (NDC 0069-3500-01) contains 10 mg zavegepant and is supplied as a ready-to-use, unit-dose...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Hypersensitivity Reactions
Inform...
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