Indication
BREXAFEMME® is a triterpenoid antifungal indicated for Treatment of VVC and Reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in adult and post-menarchal pediatric females.
Important Safety Information
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 a history of hypersensitivity to ibrexafungerp
- When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
- Most common adverse reactions observed in clinical trials (incidence ≥2%) of VVC were diarrhea, nausea, abdominal pain, dizziness, and vomiting. Most common adverse reactions observed in a clinical trial of RVVC were headache, abdominal pain, diarrhea, nausea, urinary tract infection and fatigue
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1‑888‑982‑SCYX (1‑888‑982‑7299) or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
- BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
- BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment
- When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
- Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information and Patient Information.
References
1. BREXAFEMME. Prescribing Information. SCYNEXIS, Inc.; 2021. 2. Data on file. SCYNEXIS, Inc., Jersey City. NJ.
