ZAVZPRET Dosage & Rx Info | Uses, Side Effects

Zavzpret Generic Name & Formulations

Legal Class

General Description

Zavegepant 10mg; per nasal spray.

Pharmacological Class

Calcitonin gene-related peptide (CGRP) receptor antagonist.

How Supplied

Nasal spray (single dose)—6 units

Storage

Store Zavzpret 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) [see USP controlled room temperature].

Do not freeze. Do not test spray, prime, or press the plunger before use.

Manufacturer

Pfizer Inc.

Generic Availability

Mechanism of Action

Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.

Zavzpret Indications

Indications

Acute treatment of migraine with or without aura.

Limitations of Use

Not for prevention of migraine.

Zavzpret Dosage and Administration

Adult

1 spray (10mg) in one nostril as needed. Max 10mg in 24hr period.

Children

Not established.

Zavzpret Contraindications

Not Applicable

Zavzpret Boxed Warnings

Not Applicable

Zavzpret Warnings/Precautions

Warnings/Precautions

Discontinue and treat if hypersensitivity reaction occurs. Severe hepatic impairment or renal impairment (CrCl <30mL/min): avoid. Pregnancy. Nursing mothers.

Zavzpret Pharmacokinetics

Absorption

Absolute bioavailability: ~5%.

Distribution

Plasma protein bound: ~90%.

Mean apparent volume of distribution: ~1774 L.

Metabolism

Hepatic (major CYP3A4, minor CYP2D6).

Elimination

Fecal (80%), renal (11%).

Half-life: 6.55 hours.

Mean apparent clearance: 266 L/h.

Zavzpret Interactions

Interactions

Avoid concomitant OATP1B3 or NTCP inhibitors or inducers. Avoid concomitant intranasal decongestants; if unavoidable, give ≥1hr after Zavzpret dose.

Zavzpret Adverse Reactions

Adverse Reactions

Taste disorders, nausea, nasal discomfort, vomiting; hypersensitivity reactions.

Zavzpret Clinical Trials

Clinical Trials

The approval was based on data from 2 double-blind, placebo-controlled studies (ClinicalTrials.gov Identifier: NCT04571060, NCT03872453) that evaluated the efficacy and safety of zavegepant in adults with at least a 1-year history of migraine (with or without aura) and migraine attacks lasting, on average, 4 to 72 hours if untreated. In both trials, patients were randomly assigned to receive a single intranasal dose of zavegepant or placebo.

Results from both studies showed that treatment with zavegepant was statistically superior to placebo on the coprimary endpoints of pain freedom and freedom from most bothersome symptom (nausea, photophobia, phonophobia) at 2 hours.

In the pivotal phase 3 study, zavegepant was also found to be statistically significantly superior to placebo for the additional efficacy endpoints of pain relief at 2 hours post-dose, return to normal function at 2 hours post-dose, sustained pain freedom from 2 to 48 hours post-dose, and phonophobia and photophobia freedom at 2 hours post-dose.

Zavzpret

PAGE CONTENTS