Uses of Cresemba:

• It is used to treat fungal infections.

What do I need to tell my doctor BEFORE I take Cresemba?

• If you are allergic to Cresemba (isavuconazonium sulfate capsules); any part of Cresemba (isavuconazonium sulfate capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have Familial Short QT syndrome.
• If you are taking any of these drugs: Carbamazepine, ketoconazole, phenobarbital or another drug like it, rifampin, ritonavir, or St. John's wort.
• If you are breast-feeding. Do not breast-feed while you take Cresemba (isavuconazonium sulfate capsules).

This is not a list of all drugs or health problems that interact with Cresemba (isavuconazonium sulfate capsules).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cresemba (isavuconazonium sulfate capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Cresemba?

• Tell all of your health care providers that you take Cresemba (isavuconazonium sulfate capsules). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Women must use birth control while taking Cresemba (isavuconazonium sulfate capsules) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

How is this medicine (Cresemba) best taken?

Use Cresemba (isavuconazonium sulfate capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, open, or dissolve.
• Do not take Cresemba (isavuconazonium sulfate capsules) out of the blister pack until you are ready to take it. Take Cresemba (isavuconazonium sulfate capsules) right away after opening the blister pack. Do not store the removed drug for future use.
• Be sure to only open the capsule pocket. Do not open the pocket that contains the desiccant (protects the capsule from moisture).
• Keep taking Cresemba (isavuconazonium sulfate capsules) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Chest pain.
• Feeling confused.
• Shortness of breath.
• Swelling in the arms or legs.
• Very bad dizziness or passing out.
• Very bad and sometimes deadly liver problems have happened with Cresemba (isavuconazonium sulfate capsules). Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Cresemba?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Back pain.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Cough.
• Feeling tired or weak.
• Headache.
• Trouble sleeping.
• Anxiety.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Cresemba?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Cresemba (isavuconazonium sulfate capsules), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.