From the FDA Drug Label
UBRELVY is contraindicated: • With concomitant use of strong CYP3A4 inhibitors [see Drug Interactions (7.1)] • In patients with a history of serious hypersensitivity to ubrogepant or any component of UBRELVY. Reactions have included anaphylaxis, dyspnea, and facial or throat edema [see Warnings and Precautions (5.1)]
The contraindications for Ubrelvy (ubrogepant) are:
- Concomitant use with strong CYP3A4 inhibitors
- History of serious hypersensitivity to ubrogepant or any component of UBRELVY, which can manifest as anaphylaxis, dyspnea, or facial or throat edema 1 1 1
From the Research
Ubrelvy (ubrogepant) should not be used in patients with a history of hypersensitivity to ubrogepant or any of its components, and it is contraindicated when taken concurrently with strong CYP3A4 inhibitors. The contraindications for Ubrelvy (ubrogepant) are primarily focused on minimizing the risk of adverse effects and ensuring the safe use of the medication. Key points to consider include:
- Hypersensitivity to ubrogepant or its components is a clear contraindication, as it can lead to severe allergic reactions 2.
- Concurrent use with strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, or certain HIV protease inhibitors, is contraindicated due to the potential for significantly increased ubrogepant blood levels and risk of side effects 2.
- Patients with severe hepatic impairment (Child-Pugh Class C) should avoid Ubrelvy due to the risk of potentially dangerous drug accumulation 2.
- While not an absolute contraindication, Ubrelvy requires dose adjustment for patients with moderate hepatic impairment and those taking moderate CYP3A4 inhibitors 2.
- Ubrelvy is not recommended during pregnancy unless clearly necessary, and caution should be exercised during breastfeeding, highlighting the need for careful consideration in these populations 2.
- The safety of using Ubrelvy with other acute migraine medications, particularly ergot derivatives or other CGRP receptor antagonists, has not been established, so concurrent use should be avoided to prevent potential interactions 2. These contraindications are based on the metabolism of ubrogepant by the CYP3A4 enzyme system and the potential for drug accumulation and increased adverse effects when this pathway is interfered with 2.