Zavegepant is a CGRP receptor antagonist that treats acute migraine by blocking CGRP activity, reducing vasodilation and calming pain-related nerve pathways (especially in the trigeminal system).
Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. In acute migraine, the release of CGRP increases vasodilation and modulates neuronal excitability, which facilitates pain responses in structures for migraine pain transmission, such as the trigeminal system. Therefore, CGRP receptor antagonists such as Zavegepant inhibit vasodilation mechanisms and desensitize neuronal circuits.
Zaveg Antimigraine Nasal Spray: Each metered dose spray contains Zavegepant Hydrochloride INN equivalent to Zavegepant 10 mg.
Zaveg is indicated for the acute treatment of migraine with or without aura in adults.
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.
Zavegepant is contraindicated in patients with known hypersensitivity to Zavegepant or any of its components.
Hypersensitivity reactions, including facial swelling and urticaria, have occurred in patients treated with Zavegepant in clinical studies. If a hypersensitivity reaction occurs, discontinue Zavegepant and initiate appropriate therapy
Taste disorders, allergic reactions, nausea, nasal discomfort and vomiting may occur.
Co-administration of Zavegepant with inhibitors of the organic anion transporting polypeptide 1B3 (OATP1B3) or sodium taurocholate co-transporting polypeptide (NTCP) transporters may result in a significant increase in Zavegepant exposure and co-administration with inducers of OATP1B3 or NTCP transporters may result in a decrease in Zavegepant exposure. Avoid co-administration of Zavegepant with drugs that inhibit OATP1B3 or NTCP transporters and with drugs that induce OATP1B3 or NTCP transporters. Concomitant administration of Zavegepant with intranasal decongestants may decrease the absorption of Zavegepant. Avoid concomitant administration of intranasal decongestants with Zavegepant. When concomitant use is unavoidable, intranasal decongestants should be administered at least 1 hour after Zavegepant administration.
Use in pregnancy: There are no adequate and well-controlled studies with Zavegepant in pregnant women to inform a drug-associated risk. Therefore, it should be used during pregnancy where there are no alternatives and benefits outweigh risks.
Use in lactation: There are no data available clinical data on the excretion of Zavegepant into human milk. A decision should be made to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.
Use in children & adolescents: The safety and effectiveness of Zavegepant have not been established in patients under the age of 18 years.
Use in hepatic impairment: No dosage adjustment of Zaveg is necessary in patients with mild hepatic impairment (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B). Zavegepant has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Avoid use of Zaveg in patients with severe hepatic impairment
Use in renal impairment: No dosage adjustment of Zaveg is necessary in patients with estimated creatinine clearance (CLcr) 30 mL/min or greater. Avoid use of Zaveg in patients with CLcr less than 30 mL/min.
Zaveg Antimigraine Nasal Spray: Each bottle contains aqueous solution of Zavegepant Hydrochloride for 10 metered sprays.
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