Pronunciation:

eye-brex-a-FUNJ-erp

Brand Names:

• Brexafemme

Dosage Forms:

• Tablet

Warnings:

Warning: Risk of Embryo-Fetal ToxicityIbrexafungerp is contraindicated in pregnancy because it may cause fetal harm based on findings from animal reproductive studies.For females of reproductive potential, verify that the patient is not pregnant prior to initiating ibrexafungerp treatment. Reassessing pregnancy status prior to each dose is recommended when ibrexafungerp is used monthly for 6 months for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).Advise females of reproductive potential to use effective contraception during treatment of vulvovaginal candidiasis (VVC) and throughout the 6-month treatment period for reduction in the incidence of RVVC with ibrexafungerp and, for 4 days after the last dose .

Classifications:

Therapeutic—

Antifungal

Pharmacologic—

Glucan Synthesis Inhibitor

Uses of This Medicine:

Ibrexafungerp is used to treat fungal or yeast infections, including vulvovaginal candidiasis. It is also used to reduce the risk of the vulvovaginal candidiasis infection coming back. This medicine works by killing the fungus or yeast, or preventing its growth.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ibrexafungerp in adolescent females who have started their menstrual period. However, safety and efficacy have not been established in adolescent females who have not started their menstrual period.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibrexafungerp in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Apalutamide
• Boceprevir
• Bosentan
• Carbamazepine
• Cenobamate
• Clarithromycin
• Cobicistat
• Conivaptan
• Cyclosporine
• Dabrafenib
• Duvelisib
• Efavirenz
• Enzalutamide
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ivosidenib
• Ketoconazole
• Larotrectinib
• Lenacapavir
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Phenytoin
• Pirtobrutinib
• Posaconazole
• Primidone
• Repotrectinib
• Rifabutin
• Rifampin
• Ritlecitinib
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Trofinetide
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For vulvovaginal candidiasis:
    • Adults and adolescents who have started their menstrual period—300 milligrams (mg) (two 150 mg tablets) 2 times a day, at least 12 hours apart (eg, morning and evening).
    • Adolescent females who have not started their menstrual period—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Difficulty in breathing or swallowing

fast heartbeat

lower stomach pain or cramps

skin itching, rash, or redness

swelling of the face, throat, or tongue

vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

nausea

stomach pain

Less common

Back pain

bloated

dizziness

excess air or gas in the stomach or intestines

full feeling

passing gas

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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