ibrexafungerp
Brexafemme
Pharmaceutical company: Scynexis, Inc.
Pharmacologic classification:Triterpenoid antifungal
Therapeutic classification:Antifungal
AVAILABLE FORMS
Tablets: 150 mg
INDICATIONS AND DOSAGES
Treatment of patients with vulvovaginal candidiasis
Adults and postmenarchal pediatric females: 300 mg (two 150-mg tablets) PO administered approximately 12 hours apart (in the morning and in the evening) for one day, for a total daily dosage of 600 mg (total of 4 tablets for one course of therapy).
Adjust-a-dose: If taking a concomitant strong CYP3A inhibitor, administer one 150-mg tablet approximately 12 hours apart (in the morning and in the evening) for 1 day (total of 2 tablets for one course of therapy).
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in pregnancy or in patients hypersensitive to the drug or its components.
- Safety has not been established in premenarchal pediatric females.
PREGNANCY-LACTATION-REPRODUCTION
- This drug may cause fetal harm; use is contraindicated in pregnancy.
- Verify the pregnancy status in females of reproductive potential prior to initiating treatment.
- If this drug is inadvertently administered during pregnancy or if pregnancy is detected within 4 days after a patient receives the drug, pregnant women exposed to the drug and health care providers should report pregnancies to Scynexis, Inc. at 1-888-982-SCYX (7299).
- There is no information regarding this drug’s presence in human breast milk; weigh the risk to the breastfed child.
- Advise females of reproductive potential to use effective contraception during treatment and for 4 days after the last dose.
INTERACTIONS
Drug-drug. Strong CYP3A inhibitors (ketoconazole, itraconazole): May significantly increase ibrexafungerp level; reduce ibrexafungerp dosage.
Strong/moderate CYP3A inducers (rifampin, carbamazepine, phenytoin, long-acting barbiturates, bosentan, efavirenz, or etravirine): May significantly reduce ibrexafungerp level; avoid use together.
Drug-herb. St. John’s wort: May significantly reduce ibrexafungerp level; discourage use together.
ADVERSE REACTIONS
CNS: dizziness.
GI: diarrhea, nausea, abdominal pain, vomiting, flatulence.
GU: dysmenorrhea, vaginal bleeding.
Hepatic: elevated transaminases.
Musculoskeletal: back pain.
Skin: rash.
Other: hypersensitivity reaction.
Reactions in bold italics are life-threatening.
Released: September 2021
Nursing Drug Handbook
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