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.
*Offer not available to patients enrolled in Medicare, Medicaid, or any other federal or state healthcare programs. Restrictions, including savings maximums, apply. Patient out-of-pocket expense will vary depending on insurance coverage. UBRELVY coupon becomes valid upon activation of offer. Oral triptan medication coupon becomes valid two (2) weeks from activation of offer and expires six (6) weeks from activation of offer. For full Terms and Conditions, visit UBRELVY.com/challenge or call 1-844-577-6239 for more information.
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US-UBR-240135 06/24