Zavzpret
(Zavegepant)Zavzpret Prescribing Information
Warnings and Precautions ( 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists in the postmarketing setting. Some of the patients receiving a CGRP antagonist who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with ZAVZPRET for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of ZAVZPRET is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. 5.3 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. In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. ZAVZPRET should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and 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. | 3/2025 |
ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults.
ZAVZPRET is not indicated for the preventive treatment of migraine.
• The recommended dose is 10 mg given as a single spray in one nostril, as needed. ()2.1 Dosing InformationThe 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). The safety of treating more than 8 migraines in a 30-day period has not been established.
• The maximum dose in a 24-hour period is 10 mg (one spray). ()2.1 Dosing InformationThe 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). The safety of treating more than 8 migraines in a 30-day period has not been established.
• The safety of treating more than 8 migraines in a 30-day period has not been established. ()2.1 Dosing InformationThe 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). The safety of treating more than 8 migraines in a 30-day period has not been established.
Nasal spray: 10 mg of zavegepant per device. Each unit-dose nasal spray device delivers a single spray containing 10 mg of zavegepant.
• Avoid use in patients with severe hepatic impairment. ()8.6 Hepatic ImpairmentNo dosage adjustment of ZAVZPRET is necessary in patients with mild hepatic impairment (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B). ZAVZPRET has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Avoid use of ZAVZPRET in patients with severe hepatic impairment
[see Clinical Pharmacology (12.3)].• Avoid use in patients with CLcr < 30 mL/min. ()8.7 Renal ImpairmentNo dosage adjustment of ZAVZPRET is necessary in patients with estimated creatine clearance (CLcr) 30 mL/min or greater. Avoid use of ZAVZPRET in patients with CLcr less than 30 mL/min
[see Clinical Pharmacology (12.3)].
ZAVZPRET is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or any of the components of ZAVZPRET
Hypersensitivity reactions, including facial swelling and urticaria, have occurred in patients treated with ZAVZPRET in clinical studies. If a hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy