Ubrogepantdosage

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. 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.

2.1 Recommended

Dosage The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food. If needed, a second dose may be taken 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.

2.2 Dosage Modification s

Dosing modifications for concomitant use of specific drugs and for patients with hepatic or renal impairment are provided in Table 1.

Table 1: Dose Modifications for Drug Interactions and for Specific Populations Dosage Modifications Initi a l Dose Second Dose a (if needed) Concomitant Drug Moderate CYP3A4 Inhibitors 50 mg Avoid within 24 hours Weak CYP3A4 Inhibitors 50 mg 50 mg Strong CYP3A4 Inducers Avoid concomitant use Weak & Moderate CYP3A4 Inducers 100 mg 100 mg BCRP and/or P-gp only Inhibitors 50 mg 50 mg Spec i fic Populations Severe Hepatic Impairment (Child-Pugh Class C) 50 mg 50 mg Severe Renal Impairment (CLcr 15-29 mL/min) 50 mg 50 mg End-Stage Renal Disease (CLcr <15 mL/min) Avoid use a Second dose may be taken at least 2 hours after the initial dose