2.1 Recommended Dosage

​Treatment of VVC: The recommended dosage of BREXAFEMME in adult and post-menarchal pediatric females is 300 mg (two 150 mg tablets) administered approximately 12 hours apart (e.g., in the morning and in the evening) for one day, for a total daily dosage of 600 mg (four 150 mg tablets).

​Reduction in the Incidence of RVVC: The recommended dosage of BREXAFEMME to prevent recurrences is 300 mg (two 150 mg tablets) administered approximately 12 hours apart (e.g., in the morning and in the evening) for one day, for a total daily dosage of 600 mg (four 150 mg tablets) monthly for six months.

BREXAFEMME may be taken with or without food.

2.2 Dosage Modifications in Patients due to Concomitant Use of a Strong Inhibitor of Cytochrome P450 Isoenzymes (CYP) 3A

With concomitant use of a strong CYP3A inhibitor, administer BREXAFEMME 150 mg approximately 12 hours apart (e.g., in the morning and in the evening) for one day. No dosage adjustment is warranted in patients with concomitant use of a weak or moderate CYP3A inhibitor [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

2.3 Pregnancy Evaluation Prior to Initiating Treatment

For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with BREXAFEMME. Reassessment of pregnancy status prior to each dose is recommended when BREXAFEMME is used monthly for 6 months for reduction in the incidence of RVVC [see Contraindications (4), Warning and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].