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This site is intended for US healthcare professionals only.

WATCH THE MOA
✕

Don’t inhibit
yeast growth

Kill it with BREXAFEMME1

Don’t inhibit yeast growth

Kill it with BREXAFEMME1

A broad-spectrum* triterpenoid antifungal with fungicidal activity1

  • bullet-point-icon BREXAFEMME belongs to a novel class known as triterpenoid antifungals1
  • bullet-point-icon BREXAFEMME works by blocking glucan synthase, an enzyme present in fungal cells but not human cells1
  • bullet-point-icon This disrupts the fungal cell wall integrity, leading to cell death. This fungicidal activity kills Candida1*
  • bullet-point-icon BREXAFEMME belongs to a novel class known as triterpenoid antifungals1
  • bullet-point-icon BREXAFEMME works by blocking glucan synthase, an enzyme present in fungal cells but not human cells1
  • bullet-point-icon This disrupts the fungal cell wall integrity, leading to cell death. This fungicidal activity kills Candida1*

BREXAFEMME has broad-spectrum activity1*

Clinical efficacy shown vs Candida species, including albicans tick mark
In vitro activity vs non-albicans Candida tick mark
In vitro activity vs fluconazole-resistant strains tick mark
Vaginal tissue penetration† tick mark
Retains activity in low pH‡ tick mark

*Based on in vitro studies. Clinical significance is unknown.1

†In animal studies, BREXAFEMME exhibited vaginal tissue penetration after oral administration—reaching up to 9 times the plasma concentration.1

‡BREXAFEMME retained antifungal activity based on minimal inhibitory concentration values when tested at pH 4.5 (the normal vaginal pH).1

Discover the clinical cure1,2

See Trial Results

Prescribe BREXAFEMME

See Safety Data

SAY NO MORE to vaginal yeast infections. Prescribe BREXAFEMME today.

✕

SAY NO MORE to vaginal yeast infections. Prescribe BREXAFEMME today.

✕

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.

CONTRAINDICATIONS

BREXAFEMME is contraindicated in:

  • Pregnancy
  • 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.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

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.

References:

  1. BREXAFEMME. Prescribing Information. SCYNEXIS, Inc.; 2022.
  2. Data on File. SCYNEXIS, Inc., Jersey City. NJ.

INDICATION

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION &
INDICATION

/ / / /

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.

CONTRAINDICATIONS

BREXAFEMME is contraindicated in:

  • Pregnancy
  • 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.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

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.

IBRWCNT230002 July 2023