Source: FDA, National Drug Code (US) Revision Year: 2020
UBRELVY is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
UBRELVY is not indicated for the preventive treatment of migraine.
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.
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 | Initial Dose | Second Dosea (if needed) |
|---|---|---|
| Concomitant Drug [see Drug Interactions (7)] | ||
| Moderate CYP3A4 Inhibitors (7.1) | 50 mg | Avoid within 24 hours |
| Weak CYP3A4 Inhibitors (7.1) | 50 mg | 50 mg |
| Strong CYP3A4 Inducers (7.2) | Avoid concomitant use | |
| Weak & Moderate CYP3A4 Inducers (7.2) | 100 mg | 100 mg |
| BCRP and/or P-gp only Inhibitors (7.3) | 50 mg | 50 mg |
| Specific Populations [see Use in Specific Populations (8)] | ||
| Severe Hepatic Impairment (Child-Pugh Class C) (8.6) | 50 mg | 50 mg |
| Severe Renal Impairment (CLcr 15-29 mL/min) (8.7) | 50 mg | 50 mg |
| End-Stage Renal Disease (CLcr <15 mL/min) (8.7) | Avoid use | |
a Second dose may be taken at least 2 hours after the initial dose
The elimination half-life of ubrogepant is approximately 5 to 7 hours; therefore, monitoring of patients after overdose with UBRELVY should continue for at least 24 hours, or while symptoms or signs persist.
Store between 20°C and 25°C (68°F and 77°F): excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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