Posology : מינונים

2        DOSAGE AND ADMINISTRATION
2.1      Recommended Dosage

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.

2.2      Dosage Modifications

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)]
Avoid within 24
Moderate CYP3A4 Inhibitors (7.1)                                 50 mg 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