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 (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.

ADVERSE REACTIONS

The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).

DRUG INTERACTIONS

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.

Please see full Prescribing Information.

STUDY DESIGN^1-4
UBRELVY was evaluated in two randomized, double-blind, placebo-controlled, multicenter trials, ACHIEVE I (UBRELVY 50 mg or 100 mg) and ACHIEVE II (UBRELVY 50 mg). The studies evaluated the efficacy and safety of UBRELVY for the acute treatment of a single migraine attack of moderate or severe intensity in adults with a history of migraine with or without aura, who had 2 to 8 migraine attacks of moderate to severe pain in each of the previous 3 months. Patients received either 50 mg (n=886) or 100 mg (n=448), or placebo (n=912). Data were pooled for the 50 mg analysis. A second dose of UBRELVY or rescue medication could be taken from 2 to 48 hours after the initial dose of UBRELVY. Co-primary endpoints at 2 hours for UBRELVY vs placebo were pain freedom (50 mg: 21% [182/886] or 100 mg: 21% [95/448] vs 13% [119/912]) and freedom from most bothersome symptom, defined as photophobia, phonophobia, or nausea (50 mg: 39% [342/883] vs 28% [251/910] or 100 mg: 38% [169/448] vs 28% [126/454]).

References: 1. UBRELVY. Package insert. AbbVie Inc; 2023. 2. Data on file. AbbVie Inc. 3. Lipton RB, Dodick DW, Ailani J, et al. Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial. JAMA. 2019;322(19):1887-1898. 4. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241.

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UBRELVY^® and its design are registered trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company.
US-UBR-230248 06/23