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Dosing that won’t disrupt your patient’s lifestyle1

Dosing that
won’t disrupt
your patient’s lifestyle1

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The recommended dose is 300 mg (2 tablets of 150 mg) twice a day for 1 day1

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BREXAFEMME blister pack

Each dose should be taken approximately 12 hours apart. Instruct patients to1:

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    Take 2 tablets in the morning

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    Take 2 tablets in the evening

  • BREXAFEMME may be taken with or without food.1
  • Reduce BREXAFEMME dose with concomitant use of a strong CYP3A inhibitor (eg, ketoconazole, itraconazole) to 150 mg twice daily for 1 day.
  • Prior to each dose of BREXAFEMME, 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.1

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

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

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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.

IBRWCNT230004 July 2023