Adverse reactions similar to placebo
Adverse reactions (ARs) occurring in at least 2% and at a frequency greater than placebo
- The incidence of ARs in controlled clinical trials was not affected by gender or age2
- The long-term safety of UBRELVY was further established in 813 patients in a 52-week, open-label trial, with 31,968 doses given3
UBRELVY® (ubrogepant) tablets, for oral use
Indication: UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.
Contraindications: Hypersensitivity to the active substance or to any of the excipients, concomitant use with strong CYP3A4 inhibitors.
SAFETY INFORMATION
Posology and method of administration: 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.
Special Population: 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. Avoid use in patients with end-stage renal disease.
Special warnings and precautions: Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported with use of UBRELVY.
Effects on ability to drive and use machines: UBRELVY has no or negligible influence on the ability to drive and use machines.
Interactions: Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure. Dose modifications are recommended when using moderate or weak CYP3A4 inhibitors and inducers, BCRP and/or P-gp only inhibitors.
Pregnancy and lactation: There are no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women. Based on animal data, may cause fetal harm. There are no data on the presence of ubrogepant in human milk, the effects of ubrogepant on the breastfed infant, or the effects of ubrogepant on milk production.
Undesirable effects: The most common adverse reactions were nausea (4% vs 2% placebo), somnolence (3% vs 1% placebo) and dry mouth (2% vs 1% placebo).
Full prescribing information can be received from Abbvie Biopharmaceuticals Ltd. Israel at 4 Hacharash Street, Hod Hasharon 4524075. Tel: 09-7909600, Fax: 09-7909606