Ibrexafungerp is used to treat and reduce the number of repeating vaginal yeast infections in women and in girls who have begun having periods.

Ibrexafungerp may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Use effective birth control.

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.

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

You should not use ibrexafungerp if you are allergic to 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.

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

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, 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 use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.