Note: This document contains side effect information about ibrexafungerp. Some dosage forms listed on this page may not apply to the brand name Brexafemme.
Applies to ibrexafungerp: oral tablet.
Warning
Oral route (Tablet)
Warning: Risk of Embryo-Fetal ToxicityIbrexafungerp 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 ibrexafungerp treatment. Reassessing pregnancy status prior to each dose is recommended when ibrexafungerp 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 ibrexafungerp and, for 4 days after the last dose.
Serious side effects of Brexafemme
Along with its needed effects, ibrexafungerp (the active ingredient contained in Brexafemme) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ibrexafungerp:
Less common
- Difficulty in breathing or swallowing
- fast heartbeat
- lower stomach pain or cramps
- skin itching, rash, or redness
- swelling of the face, throat, or tongue
- vaginal bleeding
Other side effects of Brexafemme
Some side effects of ibrexafungerp may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- nausea
- stomach pain
Less common
- Back pain
- bloated
- dizziness
- excess air or gas in the stomach or intestines
- full feeling
- passing gas
- vomiting
For Healthcare Professionals
Applies to ibrexafungerp: oral tablet.
Gastrointestinal
Very common (10% or more): Diarrhea (16.7%), nausea (11.9%), abdominal pain (11.4%; included abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort)
Common (1% to 10%): Vomiting
Frequency not reported: Flatulence[Ref]
Nervous system
Common (1% to 10%): Dizziness (included dizziness, postural dizziness)[Ref]
Genitourinary
Frequency not reported: Dysmenorrhea, vaginal bleeding[Ref]
Musculoskeletal
Frequency not reported: Back pain[Ref]
Hepatic
Frequency not reported: Elevated transaminases[Ref]
Dermatologic
Frequency not reported: Rash[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity reaction[Ref]
