Rx Item-Ubrelvy (ubrogepant) 50mg 6 Tablets by Allergan

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use UBRELVY safely and effectively. See full prescribing information for UBRELVY. UBRELVY (ubrogepant) tablets, for oral useInitial U.S. Approval: 2019 __________INDICATIONS AND USAGE____________UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. (1) Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. (1)_________DOSAGE AND ADMINISTRATION_______� The recommended dose is 50 mg or 100 mg taken orally, as needed. (2.1) � If needed, a second dose may be administered at least 2 hours after the initial dose. (2.1 ) �The maximum dose in a 24-hour period is 200 mg. (2.1 ) � 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. (2.2 8.6, 8.7) _______DOSAGE FORMS AND STRENGTHS_______Tablets: 50 mg and 100 mg (3)___________CONTRAINDICATIONS_______________ � Concomitant use with strong CYP3A4 inhibitors. (4)_____________ADVERSE REACTIONS_____________ The most common adverse reactions (at least 2% and greater than placebo) were nausea and somnolence. (6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.____________DRUG INTERACTIONS______________? Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure. (2.2, 7.2) ? For additional dose modifications for moderate or weak CYP3A4 inhibitors and inducers or BCRP and/or P-gp only inhibitors, refer to section 2.2. (7.1, 7.2, 7.3) ________USE IN SPECIFIC POPULATIONS________? Pregnancy: Based on animal data, may cause fetal harm. (8.1)? Avoid use in patients with end-stage renal disease. (8.7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Rx Item-Ubrelvy (ubrogepant) 50mg 6 Tabl
RX0023-6498-06

Rx Item-Ubrelvy (ubrogepant) 50mg 6 Tabl
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