Ubrelvy 728x90

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.

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).

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.

Two randomized, double-blind, placebo-controlled, multicenter trials, ACHIEVE I (50 mg or 100 mg) and ACHIEVE II (50 mg), 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. Data were pooled for the 50 mg analysis. Patients in trials were 89% female, 82% White, 15% Black, 17% Hispanic or Latino, and the mean age at study entry was 41 years (range 18-75 years).

Patients were randomized to receive an IP, either UBRELVY 50 mg (n=886) or UBRELVY 100 mg (n=448), or placebo (n=912). Patients had 1 to 60 days to treat a moderate to severe migraine with the IP. A second dose of IP or rescue medication (triptan, NSAID, acetaminophen, ergot, or opioid) could be taken from 2 to 48 hours after the initial dose of IP.

Co-primary endpoint included MBS freedom at 2 hours postdose. MBS was defined as photophobia, phonophobia, or nausea. In patients taking UBRELVY 50 mg, 39% (342/883) were absent of MBS at 2 hours vs 28% (251/910) taking placebo. In patients taking UBRELVY 100 mg, 38% (169/448) were absent of MBS at 2 hours vs 28% (126/454) taking placebo.

IP=investigational product; MBS=most bothersome symptom; NSAID=nonsteroidal anti-inflammatory drug.

References: 1. UBRELVY. Package insert. Allergan USA, Inc.; 2021. 2. Retail monthly prescription data from IQVIA on a 6-month rolling basis as of 04/22. 3. Data on file. Allergan. 4. 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. 5. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241.

UBRELVY^® and its design are registered trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company.