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Brexafemme Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Brexafemme Indications
Indications
Treatment of vulvovaginal candidiasis (VVC). Reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
Brexafemme Dosage and Administration
Adult
≥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
Brexafemme Contraindications
Contraindications
Brexafemme Boxed Warnings
Boxed Warning
Risk of embryo-fetal toxicity.
Brexafemme Warnings/Precautions
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 Pharmacokinetics
Elimination
Brexafemme Interactions
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.
Brexafemme Adverse Reactions
Adverse Reactions
Diarrhea, nausea, abdominal pain, dizziness, vomiting, headache, urinary tract infection, fatigue.
Brexafemme Clinical Trials
See Literature
Brexafemme Note
Not Applicable
Brexafemme Patient Counseling
See Literature
