What is the recommended dosing for Ubrelvy (ubrogepant) for acute migraine treatment?

Ubrelvy (Ubrogepant) Dosing for Acute Migraine Treatment

The recommended dose of Ubrelvy is 50 mg or 100 mg taken orally with or without food, with an optional second dose at least 2 hours after the initial dose if needed, not exceeding 200 mg in 24 hours. 1

Standard Dosing

• Initial dose: 50 mg or 100 mg taken orally 1
• Second dose (if needed): May be taken at least 2 hours after the initial dose 1
• Maximum daily dose: 200 mg in a 24-hour period 1
• Frequency limitation: Safety of treating more than 8 migraines in a 30-day period has not been established 1
• Administration: Can be taken with or without food 1

Dose Modifications for Drug Interactions

Moderate CYP3A4 inhibitors (e.g., ciprofloxacin, cyclosporine, fluconazole):

• Initial dose: 50 mg 1
• Avoid second dose within 24 hours 1

Weak CYP3A4 inhibitors:

• Initial dose: 50 mg 1
• Second dose (if needed): 50 mg 1

Weak or moderate CYP3A4 inducers:

• Initial dose: 100 mg 1
• Second dose (if needed): 100 mg 1

BCRP and/or P-gp only inhibitors:

• Initial dose: 50 mg 1
• Second dose (if needed): 50 mg 1

Dose Modifications for Specific Populations

Severe hepatic impairment (Child-Pugh Class C):

• Initial dose: 50 mg 1
• Second dose (if needed): 50 mg at least 2 hours after initial dose 1

Severe renal impairment (CrCl 15-29 mL/min):

• Initial dose: 50 mg 1
• Second dose (if needed): 50 mg at least 2 hours after initial dose 1

End-stage renal disease (CrCl <15 mL/min):

• Avoid use 1

Place in Therapy

• Ubrelvy is a third-line medication for acute migraine treatment and should be considered only for patients who do not tolerate or have inadequate response to combination therapy of a triptan with an NSAID or acetaminophen 2, 3
• The American College of Physicians found that CGRP antagonists-gepants may have lower likelihood of pain freedom and relief at 2 hours compared to triptan plus NSAID combination therapy 2
• Begin treatment as soon as possible after migraine onset for optimal efficacy 3

Contraindications

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): Concomitant use is contraindicated 1
• History of serious hypersensitivity to ubrogepant or any component, including anaphylaxis, dyspnea, or facial/throat edema 1

Important Safety Considerations

Medication overuse headache:

• Limit acute migraine treatments to no more than twice weekly to prevent medication overuse headache 2
• The threshold for medication overuse headache with gepants has not been definitively established, but caution is warranted with frequent use 2

Hypertension monitoring:

• Monitor for new-onset hypertension or worsening of pre-existing hypertension, particularly within the first 7 days of therapy initiation 1
• Consider discontinuation if blood pressure is inadequately controlled and no alternative etiology is identified 1

Raynaud's phenomenon:

• Monitor for new-onset or worsening of pre-existing Raynaud's phenomenon 1

Common Adverse Events

• The most common adverse reactions (≥2% and greater than placebo) are nausea and somnolence 1, 4
• In clinical trials, nausea occurred in 2.0-4.1% of patients, with higher rates in the 100 mg dose group 4
• Hypersensitivity reactions can occur within minutes, hours, or days after administration 1