Ibrexafungerp

IMPORTANT WARNING:

For all patients:

Ibrexafungerp must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that ibrexafungerp will cause loss of the pregnancy, or will cause the baby to be born too early, to die shortly after birth, or to be born with birth defects (physical problems that are present at birth).

For female patients:

If you can become pregnant, you will be asked to take a pregnancy test before each treatment with ibrexafungerp.

You should use effective birth control methods during treatment with ibrexafungerp and for 4 months after. If you are taking ibrexafungerp one day a month for 6 months to prevent recurrent vaginal yeast infections, then you will be asked to use effective birth control methods during the entire 6 months and for 4 days after,

WHY is this medicine prescribed?

Ibrexafungerp is used to treat vaginal yeast infections in adults and adolescents. It is also used to reduce the number of recurrent vaginal yeast infections. Ibrexafungerp is in a class of antifungal medications. It works by stopping the growth of the fungi that cause infection.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ibrexafungerp comes as a tablet to take by mouth. It is usually taken as two doses (approximately 12 hours apart) with or without food. If you are taking ibrexafungerp to reduce the number of recurrent vaginal yeast infections, you will be asked to repeat the daily dose once a month for 6 months. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ibrexafungerp exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If your symptoms do not improve or get worse, call your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking ibrexafungerp,

• tell your doctor and pharmacist if you are allergic to ibrexafungerp, any other medications, or any of the ingredients in ibrexafungerp tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: bosentan (Tracleer), clarithromycin (Biaxin), efavirenz (Sustiva, in Atripla), etravirine (Intelence), ketoconazole (Nizoral), itraconazole (Sporanox), medications for seizures such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, or phenytoin (Dilantin); nefazodone, nelfinavir (Viracept), rifampin (Rimactane, Rifadin, in Rifater, in Rifamate), ritonavir (Norvir), saquinavir (Fortovase, Invirase), or voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ibrexafungerp, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Do not take ibrexafungerp if you are pregnant. You will have to take a pregnancy test before starting treatment. If you become pregnant while taking ibrexafungerp, call your doctor immediately. Use effective contraception during treatment and for 4 days after your final dose. Ibrexafungerp may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

Ibrexafungerp may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• stomach pain
• dizziness

Ibrexafungerp may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.