INDICATION AND USAGE
BREXAFEMME is indicated for treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC (RVVC) in adult and post-menarchal pediatric females.
If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF EMBRYO-FETAL TOXICITY
- BREXAFEMME is contraindicated in pregnancy because it may cause fetal harm based on findings from animal reproductive studies.
- For females of reproductive potential, verify that the patient is not pregnant prior to initiating BREXAFEMME treatment. Reassessing pregnancy status prior to each dose is recommended when BREXAFEMME is used monthly for 6 months for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
- Advise females of reproductive potential to use effective contraception during treatment of vulvovaginal candidiasis (VVC) and throughout the 6-month treatment period for reduction in the incidence of RVVC with BREXAFEMME and for 4 days after the last dose.
BREXAFEMME is contraindicated in:
- Patients with hypersensitivity to ibrexafungerp
WARNINGS AND PRECAUTIONS
RISK OF EMBRYO-FETAL TOXICITY
BREXAFEMME use in pregnancy may cause fetal harm based on animal studies. Prior to each dose of BREXAFEMME in patients of reproductive potential, verify patients are not pregnant and advise them to use effective contraception during treatment for VVC and throughout the 6-month treatment for reduction in the incidence of RVVC and for 4 days after the last dose.
Most common adverse reactions (≥2%) reported in BREXAFEMME clinical trials:
- VVC: diarrhea, nausea, abdominal pain, dizziness, and vomiting
- RVVC: headache, abdominal pain, diarrhea, nausea, urinary tract infection, and fatigue
Concomitant use of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole) increases the exposure of ibrexafungerp. Reduce BREXAFEMME dosage with concomitant use of a strong CYP3A inhibitor to 150 mg twice daily for one day.
Concomitant use of strong and moderate CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, efavirenz, etravirine) may significantly reduce the exposure of ibrexafungerp. Avoid concomitant administration of BREXAFEMME with strong or moderate CYP3A inducers.
USE IN SPECIFIC POPULATIONS
There is a pregnancy safety study for BREXAFEMME. If BREXAFEMME is inadvertently administered during pregnancy or if pregnancy is detected within 4 days after a patient receives BREXAFEMME, pregnant women exposed to BREXAFEMME and healthcare providers should report pregnancies by calling 1-888-982-7299 or going to https://www.brexafemmepregnancyregistry.com.
Please see full Prescribing Information and Medication Guide, including BOXED WARNING.