Ibrexafungerp Dosage

Medically reviewed by Drugs.com. Last updated on Jan 11, 2023.

Applies to the following strengths: 150 mg

Usual Adult Dose for Vaginal Candidiasis

For treatment: 300 mg orally twice a day for 1 day (2 doses)
To prevent recurrences: 300 mg orally twice a day for 1 day (2 doses), taken once a month for 6 months

Comments:

Doses should be administered about 12 hours apart (e.g., in the morning and in the evening).
The total daily dosage is 600 mg.

Uses:

For the treatment of adult females with vulvovaginal candidiasis (VVC)
For reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in adult females

Usual Pediatric Dose for Vaginal Candidiasis

Postmenarchal females:

For treatment: 300 mg orally twice a day for 1 day (2 doses)
To prevent recurrences: 300 mg orally twice a day for 1 day (2 doses), taken once a month for 6 months

Comments:

Doses should be administered about 12 hours apart (e.g., in the morning and in the evening).
The total daily dosage is 600 mg.

Uses:

For the treatment of postmenarchal pediatric females with VVC
For reduction in the incidence of RVVC in postmenarchal pediatric females

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C): 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

US BOXED WARNING:

RISK OF EMBRYOFETAL TOXICITY: This drug is contraindicated in pregnancy because it may cause fetal harm based on animal studies. For patients of childbearing potential, verify that the patient is not pregnant before starting treatment with this drug. Pregnancy status should be reassessed before each dose when this drug is used monthly for 6 months for reduction in the incidence of RVVC. Patients of childbearing potential should be advised to use effective contraception during treatment of vulvovaginal candidiasis, throughout the 6-month treatment period for reduction in the incidence of RVVC, and for 4 days after the last dose.

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:

For patients of childbearing potential: Before starting treatment with this drug, verify that the patient is not pregnant; reassess pregnancy status before each dose when using this drug monthly for 6 months for reduction in the incidence of RVVC.
May administer with or without food
Administer the 2 doses about 12 hours apart (e.g., in the morning and in the evening).
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 (Medication Guide).
Patients of childbearing potential:
For treatment of VVC: Use effective contraception while taking this drug and for 4 days after the last dose.
For reduction in the incidence of RVVC: Use effective contraception throughout the 6-month treatment period with this drug and for 4 days after the last dose.
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.