Vaginal infections:

Indications for: BREXAFEMME

Treatment of vulvovaginal candidiasis (VVC). Reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).

Adult Dosage:

≥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.

Children Dosage:

<18yrs or pre-menarchal: not established.

BREXAFEMME Contraindications:

Pregnancy.

Boxed Warning:

Risk of embryo-fetal toxicity.

BREXAFEMME Warnings/Precautions:

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.

BREXAFEMME Classification:

Triterpenoid antifungal.

BREXAFEMME Interactions:

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.

Adverse Reactions:

Diarrhea, nausea, abdominal pain, dizziness, vomiting, headache, urinary tract infection, fatigue.

Metabolism:

CYP3A4.

Drug Elimination:

Fecal (90%), renal (1%). Half-life: ~20 hours.

Generic Drug Availability:

NO

How Supplied:

Blister packs—4