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INDICATION

ZAVZPRET^® (zavegepant) is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use: ZAVZPRET is not indicated for the preventive treatment of migraine.

Important Safety Information

Contraindications: Hypersensitivity to ZAVZPRET or any of its components.

Warnings and Precautions

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, facial swelling, and urticaria, have occurred in patients treated with ZAVZPRET. If a hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists in the postmarketing setting.

Monitor patients for new-onset hypertension or worsening of pre-existing hypertension and consider whether discontinuation is warranted.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists.

If signs or symptoms of Raynaud’s phenomenon develop, discontinue ZAVZPRET. Patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

Adverse Reactions: Most common adverse reactions (occurring in ≥2% of patients treated with ZAVZPRET and greater than placebo) for ZAVZPRET vs placebo were taste disorders including dysgeusia and ageusia (18% vs 4%), nausea (4% vs 1%), nasal discomfort (3% vs 1%), and vomiting (2% vs <1%).

Drug Interactions: Avoid use with drugs that inhibit or induce OATP1B3 or NTCP transporters. Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after ZAVZPRET administration.

Use in Specific Populations: Pregnancy: It is not known if ZAVZPRET can harm an unborn baby. Lactation: It is not known whether ZAVZPRET passes into breast milk. Hepatic Impairment: Avoid use in patients with severe hepatic impairment. Renal impairment: Avoid use of ZAVZPRET in patients with creatinine clearance (CLcr) less than 30 mL/min.

Indication

ZAVZPRET (zavegepant) is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use: ZAVZPRET is not indicated for the preventive treatment of migraine.

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Prescribing Information.

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