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BREXAFEMME® (ibrexafungerp, 150 mg per tablet) Logo

This site is intended for US healthcare professionals only.

WATCH THE MOA
✕

1st or 5th yeast infection?1

Prescribe BREXAFEMME today

1st or 5th yeast infection?1

Prescribe BREXAFEMME today

Effective across a broad range of patients1

In a clinical setting, hallmark signs and symptoms of vaginal yeast infections are rated on a VSS scale from 0 (absent) to 3 (severe) to assess severity.1

These signs and symptoms include1:
  • Erythema
  • Edema
  • Excoriation
  • Itching
  • Burning
  • Irritation

94%
of patients in the clinical trials had a baseline VSS score of ≥7.2

BREXAFEMME clinical outcomes remained consistent regardless of
severity of VSS at baseline, weight, race, ethnicity, and Candida species.1

VSS=vulvovaginal signs and symptoms.



Clinical outcomes were consistent regardless of baseline VSS severity2

Chart showing clinical outcomes with BREXAFEMME® (ibrexafungerp tablets) by baseline severity score at test of cure visit (Day 10)
Chart showing clinical outcomes with BREXAFEMME® (ibrexafungerp tablets) by baseline severity score at test of cure visit (Day 10)

Icon of a woman’s head

VANISH 303 and 306 were the largest Phase 3 clinical trials for acute VVC and used the most stringent definition of clinical cure of any vaginal yeast infection treatment, VSS=0, which indicates the total disappearance of all signs and symptoms in patients.1,2

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Studied in patients with moderate-to-severe VSS5

of patients at baseline had a VSS score of ≥7

No signs
or symptoms

0

1

2

3

4

5

6

7

8

9

10

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13

14

15

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1718

Severe signs
and symptoms

Discover efficacy that cures.1,2


See Trial Results

Don’t just slow yeast growth—kill it with BREXAFEMME.1

Explore MoA

MoA=mechanism of action.

Evaluated in a wide range of patient types.

LEARN MORE
✕

Studied in a representative population

Demographics and Baseline Characteristics*1

Overall baseline characteristics were similar between treatment groups, including the severity of vaginal infections at baseline.

Trial 1
(BREXAFEMME: n=190; placebo: n=100) 		Trial 2
(BREXAFEMME: n=189; placebo: n=89)
Average age 34 (min 17, max 67) 34 (min 18, max 65)
<50 years old 91% 92%
White 54% 81%
Black or African American 40% 19%
Hispanic/Latina 26% 10%
Average BMI 30 26
History of diabetes 9% 5%
Median VSS score at baseline 9 (min 4, max 18) 10 (min 4, max 18)
% culture positive with Candida albicans 92% 89%
Trial 1
(BREXAFEMME: n=190; placebo: n=100)
Average age
34 (min 17, max 67)
<50 years old
91%
White
54%
Black or African American
40%
Hispanic/Latina
26%
Average BMI
30
History of diabetes
9%
Median VSS score at baseline
9 (min 4, max 18)
% culture positive with Candida albicans
92%
Trial 2
(BREXAFEMME: n=189; placebo: n=89)
Average age
34 (min 18, max 65)
<50 years old
92%
White
81%
Black or African American
19%
Hispanic/Latina
10%
Average BMI
26
History of diabetes
5%
Median VSS score at baseline
10 (min 4, max 18)
% culture positive with Candida albicans
89%

Data reflect the modified intent to treat (mITT) efficacy population which included randomized subjects with a baseline culture positive for Candida species who took at least 1 dose of study medication.

BMI=body mass index; VSS=vulvovaginal signs and symptoms.

KEY INCLUSION CRITERIA

Non-pregnant postmenarchal females with a diagnosis of VVC meeting the following criteria:

  • Composite VSS minimum score of ≥4 with at least 2 signs or symptoms having a score of 2 (moderate) or greater
  • Positive microscopic exam with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts
  • Normal vaginal pH (≤4.5)

PRIMARY ENDPOINT

Percentage of subjects with complete clinical response (VSS score of 0) at Day 10.

KOH=potassium hydroxide; VSS=vulvovaginal signs and symptoms.

ADDITIONAL ENDPOINT

Sustained resolution of VVC signs and symptoms at Day 25.

KOH=potassium hydroxide;
VSS=vulvovaginal signs and symptoms.

TREATMENT

Single day of BREXAFEMME 600mg (two 150 mg tabs per dose, administered 12 hours apart).

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

Request a Rep
✕

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

Request a Rep
✕

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.

Important Safety Information

Indication

/ / / /
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 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.