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A BOLD approach that's well tolerated

A well-established safety profile1

  • BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp1
  • The most common adverse events reported were GI side effects, with the majority being mild and transient6-8
  • 2 out of 545 patients studied in phase 3 clinical trials discontinued treatment with BREXAFEMME due to dizziness (1 patient) and vomiting (1 patient)1

MOST COMMON ADVERSE REACTIONS (INCIDENCE ≥2%)1

BREXAFEMME
(N=545)
PLACEBO
(N=275)
Diarrhea 16.7% 3.3%
Nausea 11.9% 4.0%
Abdominal Pain* 11.4% 5.1%
Dizziness 3.3% 2.5%
Vomiting 2.0% 0.7%
BREXAFEMME
(N=545)
Diarrhea
16.7%
Nausea
11.9%
Abdominal Pain*
11.4%
Dizziness
3.3%
Vomiting
2.2%
 
PLACEBO
(N=275)
Diarrhea
3.3%
Nausea
4.0%
Abdominal Pain*
5.1%
Dizziness
2.5%
Vomiting
0.7%
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Prescribe with confidence

  • There was no QTc interval prolongation at >5 times the concentration of the indicated dose in clinical trials1
  • 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 to SCYNEXIS, Inc. at 1-888-982-SCYX (7299)
BREXAFEMME® (ibrexafungerp,150 mg per tablet) HCP Site

Indication

BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).

Important Safety Information

  • 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. Scynexis, Inc. Updated June 2, 2021. Accessed July 2, 2021. https://www.scynexis.com/news-media/press-releases/detail/240/scynexis-announces-fda-approval-of-brexafemme. 3. Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the management of candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infec Dis. 2016;62(4):e1–50. 4. Gintjee TJ, Donnelley MA, Thompson GR 3 rd . Aspiring antifungal: review of current antifungal pipeline developments. J Fungi (Basel). 2020:6(1):28 doi:10.3390/jof601028. 5. Data on file [1]. SCYNEXIS, Inc., Jersey City, NJ. 6. Data on file [2]. SCYNEXIS, Inc., Jersey City, NJ. 7. Data on file [3]. SCYNEXIS, Inc., Jersey City. NJ. 8. Data on file [4]. SCYNEXIS, Inc., Jersey City. NJ.

Important Safety Information

Indication

  • 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.

BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).