Ibrexafungerp (eye-brex-a-FUNJ-erp)

Treats vaginal yeast infections, including vulvovaginal candidiasis. Also reduces the risk of the vulvovaginal candidiasis infection coming back.

Brand Name(s):

Brexafemme

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ibrexafungerp works. Tell your doctor if you are using bosentan, dabigatran, efavirenz, etravirine, itraconazole, ketoconazole, phenytoin, pravastatin, rifampin, St John's wort, or barbiturates.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during the 6 month treatment period and for at least 4 days after the last dose.
• Tell your doctor if you are breastfeeding, or if you have other medical problems.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Lower stomach pain or cramps
• Vaginal bleeding

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Diarrhea, nausea, vomiting, passing gas, stomach pain
• Dizziness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088