Zavegepant

Zaveg nasal spray is indicated for the acute treatment of migraine with or without aura in adults.

Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. The relationship between pharmacodynamic activity and the mechanism by which zavegepant exerts its clinical effects is unknown. No clinically relevant differences in resting blood pressure were observed when zavegepant was concomitantly administered with sumatriptan (12 mg subcutaneous, given as two 6 mg doses separated by one hour) compared with sumatriptan alone to healthy volunteers.

The recommended dose of Zavegepant 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.

Avoid use with drugs that inhibit OATP1B3 or NTCP transporters.

Avoid use with drugs that induce OATP1B3 or NTCP transporters.

Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after Zaveg administration.

Zavegepant is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or any of the components of this nasal spray.

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

Pregnancy : There are no adequate data on the developmental risk associated with the use of Zavegepant in pregnant women. No adverse developmental effects were observed following subcutaneous administration of zavegepant to pregnant animals at doses associated with plasma exposures higher than those used clinically. Lactation : There are no data on the presence of zavegepant or its metabolites in human milk, the effects of zavegepant on the breastfed infant, or the effects of zavegepant on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zavegepant and any potential adverse effects on the breastfed infant from Zavegepant or from the underlying maternal condition.

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. Hypertension : New-onset or worsening of pre-existing hypertension may occur. Raynaud's Phenomenon : New-onset or worsening of pre-existing Raynaud’s phenomenon may occur.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.