UBRELVY- ubrogepant tablet
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.
|Dosage Modifications||Initial Dose||Second Dose a (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|
|Spec i fic 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
UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side.
UBRELVY 100 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U100” on one side.
UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors [see Drug Interactions ( 7.1)].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of UBRELVY was evaluated in 3,624 subjects who received at least one dose of UBRELVY. In two randomized, double-blind, placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 1,439 patients received UBRELVY 50 mg or 100 mg [see Clinical Studies ( 14)] . Of the UBRELVY-treated patients in these 2 studies, approximately 89% were female, 82% were White, 15% were Black, and 17% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range of 18-75 years).
Long-term safety was assessed in 813 patients, dosing intermittently for up to 1year in an open-label extension study. Patients were permitted to treat up to 8 migraines per month with UBRELVY. Of these 813 patients, 421 patients were exposed to 50 mg or 100 mg for at least 6 months, and 364 patients were exposed to these doses for at least one year, all of whom treated at least two migraine attacks per month, on average. In that study, 2.5% of patients were withdrawn from UBRELVY because of an adverse reaction. The most common adverse reaction resulting in discontinuation in the long-term safety study was nausea.
Adverse reactions in Studies 1 and 2 are shown in Table 2.
|Placebo (N= 984) %||UBRELVY 50 mg (N=954) %||UBRELVY 100 mg (N=485) %|
*Somnolence includes the adverse reaction-related terms sedation and fatigue.
Co-administration of UBRELVY with ketoconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of ubrogepant [see Clinical Pharmacology ( 12.3) ]. UBRELVY should not be used with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) [see Contraindication s ( 4)].
Co-administration of UBRELVY with verapamil, a moderate CYP3A4 inhibitor, resulted in an increase in ubrogepant exposure [see Clinical Pharmacology ( 12.3) ]. Dose adjustment is recommended with concomitant use of UBRELVY and moderate CYP3A4 inhibitors (e.g., cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice) [see Dosage and Administration ( 2.2)].
No dedicated drug interaction study was conducted with ubrogepant and weak CYP3A4 inhibitors. Dose adjustment is recommended with concomitant use of UBRELVY with weak CYP3A4 inhibitors [see Dosage and Administration ( 2.2)].
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