IMPORTANT SAFETY INFORMATION
Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, 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.
The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).
- 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
DOSAGE AND ADMINISTRATION
- 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.
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.