Ubrogepant

FDA label

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Renal No adjustment for mild–moderate. Severe (CLcr 15–29): 50 mg initial, 50 mg second if needed. ESRD (<15): avoid

Hepatic No adjustment for mild–moderate. Severe (Child-Pugh C): 50 mg initial, 50 mg second if needed

Second dose, if needed, at least 2 hours after the initial dose; max 200 mg in 24 hours

Instructions

• Take orally with or without food
• If needed, a second dose may be taken ≥2 h after the initial dose
• Maximum 200 mg in 24 hours
• Safety of treating >8 migraines per 30 days not established

Contraindications

• Concomitant use of strong CYP3A4 inhibitors

Cautions

• Hypersensitivity reactions (anaphylaxis, dyspnea, facial/throat edema) — can occur minutes to days after dosing
• Hypertension — new-onset or worsening
• Raynaud's phenomenon — new-onset or worsening

Adverse reactions

• Nausea
• Somnolence
• Dry mouth

Pregnancy No adequate human data; animal embryofetal harm at high maternally-toxic doses; pregnancy registry available

Lactation Excreted in breast milk in low amounts (relative infant dose ~0.15%); weigh benefits/risks