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HIGHLIGHTS OF PRESCRIBING INFORMATION …

HIGHLIGHTS OF PRESCRIBING INFORMATION _____ _____. CONTRAINDICATIONS. These HIGHLIGHTS do not include all the INFORMATION Concomitant use with strong CYP3A4 inhibitors. (4). needed to use UBRELVY safely and effectively. See full _____ _____. PRESCRIBING INFORMATION for UBRELVY. ADVERSE REACTIONS. The most common adverse reactions (at least 2% and UBRELVY (ubrogepant) tablets, for oral use greater than placebo) were nausea and somnolence. ( ). Initial Approval: 2019. _____ _____ To report SUSPECTED ADVERSE REACTIONS, INDICATIONS AND USAGE. contact Allergan at 1-800-678-1605 or FDA at 1-800- UBRELVY is a calcitonin gene-related peptide receptor FDA-1088 or antagonist indicated for the acute treatment of migraine _____ _____.

UBRELVY is not indicated for the preventive treatment of migraine. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage . The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food. If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour

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