UBRELVYTM (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
Contraindication: Concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
Adverse Reactions: The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).
Dosage and Administration:
- Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure.
- Dose modifications are recommended when using the following:
- Moderate or weak CYP3A4 inhibitors and inducers
- BCRP and/or P-gp only inhibitors
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- The recommended dose is 50 mg or 100 mg taken orally, as needed.
- If needed, a second dose may be administered at least 2 hours after the initial dose.
- The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.
- Severe hepatic or severe renal impairment: Recommended dose is 50 mg; if needed, a second 50 mg dose may be taken at least 2 hours after the initial dose.
- Avoid use in patients with end-stage renal disease.