Drug Detail:Ibrexafungerp (Ibrexafungerp [ eye-brex-a-funj-erp ])
Drug Class: Miscellaneous antifungals
Usual Adult Dose for Vaginal Candidiasis
300 mg orally twice a day for 1 day
Comments:
- Doses should be administered about 12 hours apart (e.g., in the morning and in the evening).
- The total treatment dosage is 600 mg.
Use: For the treatment of adult females with vulvovaginal candidiasis
Usual Pediatric Dose for Vaginal Candidiasis
Postmenarchal females: 300 mg orally twice a day for 1 day
Comments:
- Doses should be administered about 12 hours apart (e.g., in the morning and in the evening).
- The total treatment dosage is 600 mg.
Use: For the treatment of postmenarchal pediatric females with vulvovaginal candidiasis
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Concomitant use of a strong CYP450 3A inhibitor: 150 mg orally twice a day for 1 day
Comments:
- Doses should be administered about 12 hours apart (e.g., in the morning and in the evening).
- No dosage adjustment needed with concomitant use of a weak or moderate CYP450 3A inhibitor.
Precautions
CONTRAINDICATIONS:
Pregnancy; hypersensitivity to the active component
Safety and efficacy have not been established in premenarchal pediatric females.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Before starting this drug, verify pregnancy status in patients of childbearing potential.
- May administer with or without food
- Administer doses about 12 hours apart (e.g., in the morning and in the evening) for 1 day.
- If the first dose is administered in the morning, administer the second dose that same day in the evening.
- If the first dose is administered in the afternoon or evening, administer the second dose the following morning.
Storage requirements:
- Store at 20C to 25C (68F to 77F); brief exposure to 15C to 30C (59F to 86F) permitted.
General:
- If specimens for fungal culture are obtained before therapy, antifungal therapy may be started before results are known; antifungal therapy should be adjusted accordingly when results are available.
Monitoring:
- General: For pregnancy (before starting therapy)
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Notify health care provider of known/suspected pregnancy; if you inadvertently took this drug during pregnancy, you are encouraged to report it by calling 1-888-982-7299.
- Patients of childbearing potential: Use effective contraception while taking this drug and for 4 days after the last dose.
