Ibrexafungerp

Ibrexafungerp is used to treat and lower the number of recurring vaginal yeast infections in women and in girls who have started their periods.

Ibrexafungerp may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take ibrexafungerp with or without food.

Ibrexafungerp is usually taken twice per day.

Use this medicine at evenly spaced intervals, about every 12 hours.

Store at room temperature away from moisture and heat.

Do not use if you are pregnant.

Use effective birth control.

You should not use ibrexafungerp if you are allergic to it.

It may harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using ibrexafungerp and for at least 4 days after your last dose. Tell your doctor if you become pregnant.

You may need to have a negative pregnancy test before starting this treatment. If you are pregnant, you may be enrolled in a pregnancy safety study to track the effects of ibrexafungerp on the baby.

Ask a doctor if it is safe to breastfeed while using ibrexafungerp.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common side effects of ibrexafungerp may include:

• headache;
• loose stools, nausea, stomach pain, vomiting; or
• dizziness.

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.

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 monthsComments:-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 monthsComments:-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

Take the medicine as soon as you remember, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medicines together. Some drugs can change the blood levels of other drugs you take, which may increase side effects or make the medicines less effective.

Other drugs may affect ibrexafungerp, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.