Brexafemme
- Generic Name: ibrexafungerp tablets
- Brand Name: Brexafemme
Brexafemme (Ibrexafungerp Tablets) side effects drug center
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- diarrhea,
- nausea,
- abdominal pain,
- dizziness,
- vomiting,
- painful menstrual periods,
- gas (flatulence),
- back pain,
- elevated transaminases,
- vaginal bleeding, and
- rash/hypersensitivity reaction.
What Is Brexafemme?
Brexafemme (ibrexafungerp tablets) is a triterpenoid antifungal indicated for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC, also called a vaginal yeast infection).
What Are Side Effects of Brexafemme?
Side effects of Brexafemme include:
Dosage for Brexafemme
The recommended dosage of Brexafemme in adult and post-menarchal pediatric females is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg.
Brexafemme In Children
The safety and effectiveness of Brexafemme for treatment of VVC have been established in post-menarchal pediatric females. The safety and effectiveness of Brexafemme have not been established in pre-menarchal pediatric females.
What Drugs, Substances, or Supplements Interact with Brexafemme?
Brexafemme may interact with other medicines such as:
strong CYP3A inhibitors (e.g., ketoconazole, itraconazole) and
strong and moderate CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort, long-acting barbiturates, bosentan, efavirenz, or etravirine).
Tell your doctor all medications and supplements you use.
Brexafemme During Pregnancy and Breastfeeding
Brexafemme is not recommended for use during pregnancy; it may harm a fetus. The pregnancy status in females of reproductive should be verified potential prior to initiating treatment with Brexafemme. Females of reproductive potential are advised to use effective contraception during treatment with Brexafemme and for 4 days after the last dose. 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). It is unknown if Brexafemme passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Brexafemme (ibrexafungerp tablets), for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Brexafemme Professional Information
SIDE EFFECTS
Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 545 patients were exposed to BREXAFEMME in two clinical trials of women with VVC (Trial 1 and Trial 2). The women were treated with BREXAFEMME 300 mg (two 150 mg tablets) twice a day, 12 hours apart, for one day. The women were 18 to 76 years of age (mean 34 years); 69% were White and 28% were Black or African American; 18% were of Hispanic or Latina ethnicity.
The most frequently reported adverse reactions are presented in Table 1.
There were no serious adverse reactions and 2 out of 545 (0.4%) patients discontinued treatment with BREXAFEMME due to vomiting (1 patient) and dizziness (1 patient).
Table 1. Adverse Reactions with Rates ≥2% in BREXAFEMME-Treated Patients
| Adverse Reaction | BREXAFEMME N = 545 n (%) |
Placebo N = 275 n (%) |
| Diarrhea | 91 (16.7%) | 9 (3.3%) |
| Nausea | 65 (11.9%) | 11 (4.0%) |
| Abdominal pain1 | 62 (11.4%) | 14 (5.1%) |
| Dizziness2 | 18 (3.3%) | 7 (2.5%) |
| Vomiting | 11 (2.0%) | 2 (0.7%) |
| 1 Includes abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort 2 Includes dizziness and postural dizziness |
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Other Adverse Reactions
The following adverse reactions occurred in < 2% of patients receiving BREXAFEMME in Trial 1 and Trial 2: dysmenorrhea, flatulence, back pain, elevated transaminases, vaginal bleeding, rash/hypersensitivity reaction.
DRUG INTERACTIONS
Ibrexafungerp is a substrate of CYP3A4. Drugs that inhibit or induce CYP3A may alter the plasma concentrations of ibrexafungerp and affect the safety and efficacy of BREXAFEMME [see CLINICAL PHARMACOLOGY]
Table 2 Effect of Coadministered Drugs on Ibrexafungerp Pharmacokinetics:
| Concomitant Drugs | Effect on Ibrexafungerp Concentration | Recommendation |
| Strong CYP3A inhibitors: (e.g., ketoconazole, itraconazole) | Significantly increased | Reduce the BREXAFEMME dosage [see DOSAGE AND ADMINISTRATIO] |
| Strong and Moderate CYP3A inducers: (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort, long acting barbiturates, bosentan, efavirenz, or etravirine) | Not studied in vivo or in vitro, but likely to result in significant reduction | Avoid concomitant administration |
Ibrexafungerp is an inhibitor of CYP3A4, P-gp and OATP1B3 transporter [(see CLINICAL PHARMACOLOGY]. However, given the short treatment duration for VVC, the effect of BREXAFEMME on the pharmacokinetics of substrates of CYP3A4, P-gp and OATP1B3 transporters is not considered to be clinically significant.
Read the entire FDA prescribing information for Brexafemme (Ibrexafungerp Tablets)