IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
UBRELVY is contraindicated:
- With concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
- In patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: 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.
Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including UBRELVY. Some patients who developed new-onset HTN had risk factors. There were cases requiring initiation of HTN treatment and, in some cases, hospitalization. HTN may occur at any time but was most frequently reported within 7 days of initiation. The CGRP antagonist was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN and consider whether discontinuation of UBRELVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.
Raynaud’s phenomenon (RP): Development, recurrence, or worsening of pre-existing RP has been reported following the use of CGRP antagonists, including UBRELVY. In cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. UBRELVY should be discontinued if signs or symptoms of RP develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of RP should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.
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
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.
Please see full Prescribing Information.
US-UBR-250101
