UBRELVY (ubrogepant) Proposed Mechanism of Action

Calcitonin gene-related peptide (CGRP) is believed to play a major role in the underlying pathophysiology of migraine.

CGRP is released by trigeminal C-fibers at the time of migraine attack and may contribute to symptoms associated with migraine through activation of mast cells, dilation of the vessels supplying the pain-sensitive meninges, and transmission of migraine-related stimuli within the central nervous system. UBRELVY is the first oral CGRP receptor antagonist approved for the acute treatment of migraine. UBRELVY is a small-molecule, high-affinity CGRP receptor antagonist that blocks the binding of the ligand CGRP and antagonizes CGRP receptor function. By blocking CGRP binding, UBRELVY targets an important element in the pathogenesis of migraine pain at the time of a migraine attack, when CGRP is known to be released from sensory nerve endings without inducing vasoconstriction.

UBRELVY is the first oral CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults.

UBRELVY is not indicated for the preventive treatment of migraine.

UBRELVY—bringing an acute treatment option to the management of migraine.

INDICATION

UBRELVY (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors—for example, ketoconazole, itraconazole, clarithromycin.

Hypersensitivity Reactions: UBRELVY is contraindicated in patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product. Cases, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions were not serious, and some led to discontinuation. If a serious or severe reaction occurs, discontinue UBRELVY and institute appropriate therapy.

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