Indications for: BREXAFEMME
Treatment of vulvovaginal candidiasis (VVC). Reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
≥18yrs or post-menarchal: (VVC): 300mg orally approx. 12hrs apart for 1 day; (RVVC): 300mg orally approx. 12hrs apart for 1 day, for a total daily dose of 600mg monthly for 6 months. Concomitant strong CYP3A4 inhibitors: 150mg orally approx. 12hrs apart for 1 day.
<18yrs or pre-menarchal: not established.
Risk of embryo-fetal toxicity.
May cause fetal harm. Females of reproductive potential: exclude pregnancy status prior to initiation. For RVVC: reassess pregnancy status prior to each dose when used monthly for 6 months. Advise females of reproductive potential to use effective contraception during (VVC) and throughout the 6-month treatment period (RVVC), and for 4 days after the last dose. Severe hepatic impairment: not studied. Nursing mothers.
Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole); reduce ibrexafungerp dose (see Adult dose). May be antagonized by strong or moderate CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John’s wort, long acting barbiturates, bosentan, efavirenz, etravirine); avoid concomitant use.
Diarrhea, nausea, abdominal pain, dizziness, vomiting, headache, urinary tract infection, fatigue.
Fecal (90%), renal (1%). Half-life: ~20 hours.
Generic Drug Availability: