Migraine and headache:
Indications for UBRELVY:
Acute treatment of migraine with or without aura.
Limitations of Use:
Not for preventive treatment of migraine.
Adult:
Initially 50mg or 100mg; may give a second dose at least 2hrs after initial dose (max 200mg/day). Concomitant use with moderate CYP3A4 inhibitors: initially 50mg, avoid second dose within 24hrs. Concomitant use with BCRP and/or P-gp only inhibitors or weak CYP3A4 inhibitors: initially 50mg; may give second dose after 2hrs (if needed). Concomitant use with moderate or weak CYP3A4 inducers: initially 100mg; may give second dose after 2hrs (if needed). Severe hepatic (Child-Pugh Class C) or renal (CrCl 15–29mL/min) impairment: initially 50mg; may give second dose after 2hrs (if needed). The safety of treating more than 8 migraines in a 30-day period has not been established.
Children:
Not established.
Contraindications:
Concomitant use with strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
Warnings/Precautions:
Severe hepatic (Child-Pugh Class C) or severe renal (CrCl 15–29mL/min) impairment: See Adults. ESRD (CrCl <15mL/min): avoid. Elderly. Pregnancy. Nursing mothers.
Pharmacologic Class:
Calcitonin gene-related peptide (CGRP) receptor antagonist.
Interactions:
See Contraindications. Potentiated by moderate CYP3A4 inhibitors (eg, cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice); adjust doses (see Adults). May be potentiated by BCRP and/or P-gp only inhibitors (eg, quinidine, carvedilol, eltrombopag, curcumin); adjust doses. Antagonized by strong CYP3A4 inducers (eg, phenytoin, barbiturates, rifampin, St. John's wort); avoid. Concomitant moderate or weak CYP3A4 inducers: adjust doses (see Adults).
Adverse Reactions:
Nausea, somnolence.
Generic Availability:
NO
How Supplied:
Packets—6, 8, 10, 12, 30
