ZAVZPRET™ Highlights

([zavegepant] nasal spray)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZAVZPRET safely and effectively. See full prescribing information for ZAVZPRET.
 
ZAVZPRET™ (zavegepant) nasal spray
Initial U.S. Approval: 2023

INDICATIONS AND USAGE

ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. (1)

 

Limitations of Use

ZAVZPRET is not indicated for the preventive treatment of migraine. (1)

DOSAGE AND ADMINISTRATION

•
The recommended dose is 10 mg given as a single spray in one nostril, as needed. (2.1)
•
The maximum dose in a 24-hour period is 10 mg (one spray). (2.1)
•
The safety of treating more than 8 migraines in a 30-day period has not been established. (2.1)

DOSAGE FORMS AND STRENGTHS

Nasal spray: 10 mg (3)

CONTRAINDICATIONS

Patients with a history of hypersensitivity reaction to zavegepant or to any of the components of ZAVZPRET. (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity Reactions including facial swelling and urticaria have occurred with ZAVZPRET. (5.1)

ADVERSE REACTIONS

Most common adverse reactions (at least 2% of patients treated with ZAVZPRET and greater than placebo) were taste disorders, nausea, nasal discomfort, and vomiting. (6.1)
 

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Avoid use with drugs that inhibit OATP1B3 or NTCP transporters. (7.1)
•
Avoid use with drugs that induce OATP1B3 or NTCP transporters. (7.2)
•
Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after ZAVZPRET administration. (7.3)

USE IN SPECIFIC POPULATIONS

•
Avoid use in patients with severe hepatic impairment. (8.6)
•
Avoid use in patients with CLcr < 30 mL/min. (8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZAVZPRET safely and effectively. See full prescribing information for ZAVZPRET.
 
ZAVZPRET™ (zavegepant) nasal spray
Initial U.S. Approval: 2023

INDICATIONS AND USAGE

ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. (1)

 

Limitations of Use

ZAVZPRET is not indicated for the preventive treatment of migraine. (1)

DOSAGE AND ADMINISTRATION

•
The recommended dose is 10 mg given as a single spray in one nostril, as needed. (2.1)
•
The maximum dose in a 24-hour period is 10 mg (one spray). (2.1)
•
The safety of treating more than 8 migraines in a 30-day period has not been established. (2.1)

DOSAGE FORMS AND STRENGTHS

Nasal spray: 10 mg (3)

CONTRAINDICATIONS

Patients with a history of hypersensitivity reaction to zavegepant or to any of the components of ZAVZPRET. (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity Reactions including facial swelling and urticaria have occurred with ZAVZPRET. (5.1)

ADVERSE REACTIONS

Most common adverse reactions (at least 2% of patients treated with ZAVZPRET and greater than placebo) were taste disorders, nausea, nasal discomfort, and vomiting. (6.1)
 

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Avoid use with drugs that inhibit OATP1B3 or NTCP transporters. (7.1)
•
Avoid use with drugs that induce OATP1B3 or NTCP transporters. (7.2)
•
Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after ZAVZPRET administration. (7.3)

USE IN SPECIFIC POPULATIONS

•
Avoid use in patients with severe hepatic impairment. (8.6)
•
Avoid use in patients with CLcr < 30 mL/min. (8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2023
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