Cresemba: Uses, Side Effects and Dosage

What is CRESEMBA?

CRESEMBA is a prescription medicine used to treat certain types of fungal infections in the blood or body called invasive aspergillosis and invasive mucormycosis as follows:

• CRESEMBA for injection: adults and children 1 year of age and older
• CRESEMBA capsules: adults and children 6 years of age and older who weigh 35 pounds (16 kg) or more

It is not known if CRESEMBA capsules are safe and effective in children younger than 6 years of age or who are 6 years of age and older but weigh less than 35 pounds (16 kg).

It is not known if CRESEMBA is safe and effective in children under 1 year of age.

Who should not take CRESEMBA?

Do not take CRESEMBA if you or your child:

• are allergic to CRESEMBA or any of the ingredients. See the end of this Patient Information leaflet for a complete list of ingredients in CRESEMBA.
• are taking any of the following medicines:

• ketoconazole
• high-dose ritonavir

• rifampin
• carbamazepine

• St. John’s wort (herbal supplement)
• long-acting barbiturates

• have a genetic problem that affects the electrical system of the heart (familial short QT syndrome).

Talk to your or your child’s healthcare provider or pharmacist if you are not sure if you are taking any of these medicines or have any of the conditions listed above.

Do not start taking new medicines without talking to your or your child’s healthcare provider or pharmacist.

Before you or your child take CRESEMBA, tell your healthcare provider about all of your medical conditions, including if you or your child:

• have or ever had an abnormal heart rate or rhythm. Your healthcare provider may order a test to check your heart (ECG) before starting CRESEMBA.
• have liver problems. Your healthcare provider may do blood tests to make sure you can take CRESEMBA.
• have ever had an allergic reaction to other antifungal medicines such as ketoconazole, fluconazole, itraconazole, voriconazole or posaconazole.

• are pregnant or plan to become pregnant. CRESEMBA may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Women who can become pregnant should use effective birth control while taking CRESEMBA and for 28 days after the last CRESEMBA dose. Talk to your healthcare provider about birth control methods that may be right for you.

• are breastfeeding or plan to breastfeed. CRESEMBA can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take CRESEMBA.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CRESEMBA may affect the way other medicines work, and other medicines may affect how CRESEMBA works and can cause side effects.

Ask your or your child’s healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you or your child take. Keep a list of them with you to show your or your child’s healthcare provider and pharmacist when you get a new medicine.

How should I take CRESEMBA?

• Take CRESEMBA exactly as your or your child’s healthcare provider tells you to take it.
• Do not stop taking CRESEMBA until your or your child’s healthcare provider tells you to.
• If you or your child take too much CRESEMBA, call your healthcare provider or go to the nearest hospital emergency room right away.

• CRESEMBA capsules can be taken with or without food.

• Swallow CRESEMBA capsules whole. Do not chew, crush, dissolve, or open the capsules.
• CRESEMBA for injection can be given through a nasogastric tube by your or your child’s healthcare provider.
• Do not give CRESEMBA capsules through a nasogastric tube.

Instructions on opening CRESEMBA capsules blister packaging:

CRESEMBA capsules are in child-resistant blister packaging.

Each blister section contains two pockets: one pocket for the CRESEMBA capsule and one pocket for the desiccant to protect the capsule from moisture (located to the left of the capsule).

• Only open the blister packaging at time of use. Make sure only the CRESEMBA capsule pocket is opened.
• Do not puncture the pocket containing the desiccant.
• Do not swallow or use the desiccant.

What are the possible side effects of CRESEMBA?

CRESEMBA may cause serious side effects, including:

• liver problems. Liver problems can happen in some people taking CRESEMBA. Some people who also have other serious medical problems may get severe liver problems which can lead to hepatitis, gallbladder problems, liver failure or death. Your or your child’s healthcare provider should do blood tests to check your liver before you start and while you are taking CRESEMBA. Call your or your child’s healthcare provider right away if you have any of the following symptoms of liver problems:

• itchy skin
• nausea or vomiting

• yellowing of your eyes
• feeling very tired

• flu-like symptoms

• infusion reactions. Infusion reactions can happen in people receiving CRESEMBA intravenously. If an infusion reaction happens, your or your child’s infusion will be stopped. Symptoms of an infusion reaction may include:

• low blood pressure
• difficulty breathing

• chills
• dizziness

• numbness and tingling
• changes in your sense of touch (hypoesthesia)

• severe allergic reactions. Severe allergic reactions including death can happen in some people taking CRESEMBA. Symptoms of a severe allergic reaction may include:

• swelling of your face, lips, mouth, or tongue
• wheezing
• skin rash redness, or swelling
• fast heartbeat or pounding in your chest

• trouble breathing
• severe itching
• dizziness or fainting
• sweating

1. Stop taking CRESEMBA and call your or your child’s healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

• drug interactions with cyclosporine, sirolimus, or tacrolimus. If you or your child take CRESEMBA with cyclosporine, sirolimus, or tacrolimus, your blood levels of cyclosporine, sirolimus, or tacrolimus may increase. Serious side effects can happen in your or your child’s kidney or brain if you have high levels of cyclosporine, sirolimus, or tacrolimus in your blood. Your or your child’s healthcare provider should do blood tests to check your levels of cyclosporine, sirolimus, or tacrolimus if you are taking these medicines while taking CRESEMBA. Tell your or your child’s healthcare provider right away if you have swelling in your arm or leg or shortness of breath.
• medicine interactions. Taking CRESEMBA with some other medicines may affect the way other medicines work causing serious side effects. Other medicines may affect the way CRESEMBA works, causing serious side effects. Tell your or your child’s healthcare provider about all the medicines you take.

The most common side effects of CRESEMBA in adults include:

• nausea
• vomiting
• diarrhea
• headache

• changes in the level of a liver enzyme in your blood
• low potassium
• constipation
• shortness of breath

• cough
• swelling of arms or legs
• back pain

The most common side effects of CRESEMBA in children include:

• diarrhea
• stomach pain
• vomiting
• changes to the level of a liver enzyme in your blood

• rash
• nausea
• itching
• headache

Tell your or your child’s healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of CRESEMBA. For more information, ask your or your child’s healthcare provider or pharmacist.

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

How should I store CRESEMBA capsules?

• Store CRESEMBA at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep CRESEMBA in the original package and protect it from moisture.
• Do not remove CRESEMBA from its original packaging.
• Safely throw away medicine that is out of date or no longer needed.

Keep CRESEMBA and all medicines out of the reach of children.

General information about the safe and effective use of CRESEMBA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CRESEMBA for a condition for which it was not prescribed. Do not give CRESEMBA to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about CRESEMBA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CRESEMBA that is written for health professionals.

What are the ingredients of CRESEMBA capsules?

Active ingredient: isavuconazonium sulfate.

Inactive ingredients: black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide.

Marketed and Distributed by:

Astellas Pharma US, Inc. Northbrook, IL 60062

390714-ISA- USA

CRESEMBA is a registered trademark of Astellas US LLC.

Licensed from: Basilea Pharmaceutica International Ltd.

For more information go to www.CRESEMBA.com or call 1-800-727-7003.

1. This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 12/2023