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CRESEMBA- isavuconazonium sulfate capsuleCRESEMBA- isavuconazonium sulfate injection, powder, lyophilized, for solution


  1. What Is Cresemba?
  2. Do Not Take Cresemba If You:
  3. Before You Take Cresemba, Tell Your Healthcare Provider If You:
  4. How Should I Take Cresemba Capsules?
  5. Instructions On Opening Cresemba Capsules Blister Packaging:
  6. Cresemba May Cause Serious Side Effects, Including:
  7. The Most Common Side Effects Of Cresemba Include:
  8. How Should I Store Cresemba Capsules?
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Patient Information

What Is Cresemba? 

CRESEMBAis a prescription medicine used to treat people 18 years of age and older with certain types of fungal infections in the blood or body called aspergillosis, and mucormycosis (zygomycosis). CRESEMBA may be given as capsules or through an IV placed in your arm (intravenously).

It is not known if CRESEMBA is safe and effective in children under 18 years of age.

Do Not Take Cresemba If You: 

are allergic to CRESEMBA or any of the ingredients.

Before You Take Cresemba, Tell Your Healthcare Provider If You: 


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 medications such as ketoconazole, fluconazole, itraconazole, voriconazole or posaconazole.
have any other medical conditions.
are pregnant or plan to become pregnant. It is not known if CRESEMBA will harm your unborn baby.
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. You should not breastfeed while taking CRESEMBA.

Tell your healthcare provider about all the medicines you 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 causing side effects.

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

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

How Should I Take Cresemba Capsules? 

Take CRESEMBA exactly as your healthcare provider tells you to take it.
Do notstop taking CRESEMBA until your healthcare provider tells you to.
If you take too much CRESEMBA, call your healthcare provider.
CRESEMBA capsules can be taken with or without food.
Swallow CRESEMBA capsules whole.Do notchew, crush, dissolve, or open the capsules.

Instructions On Opening Cresemba Capsules Blister Packaging: 

CRESEMBA capsules are in child resistant blister packaging. Each blister section contains two pockets One for the CRESEMBA capsule, and one 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. Ensure only CRESEMBA capsule pocket is opened.
Please refer to the picture below.
Instructions on opening Cresemba capsules blister packaging
To open the blister packaging, open from the printed side as shown above.

Step 1 to open Cresemba blister packagingBend & tear along the horizontal perforated dotted line.

Step 1 to open Cresemba blister packagingPeel the paper away from the foil backing.

Step 3 to open Cresemba blister packagingThen push the capsule through the exposed foil until released.

Step 4 to open Cresemba blister packagingIf difficult to peel, scissors may be used to open package.

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 healthcare provider should do blood tests to check your liver before you start and while you are taking CRESEMBA. Call your 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
drug interactions with cyclosporine, sirolimus, or tacrolimus.If you take CRESEMBA with cyclosporine, sirolimus, or tacrolimus, your blood levels of cyclosporine, sirolimus, or tacrolimus may increase. Serious side effects can happen in your kidney or brain if you have high levels of cyclosporine, sirolimus, or tacrolimus in your blood. Your 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 healthcare provider right away if you have swelling in your arm or leg or shortness of breath.
infusion reactions.Infusion reactions can happen in people receiving CRESEMBA intravenously. If an infusion reaction happens, your infusion will be stopped. Symptoms of an infusion reaction may include:
o
low blood pressure
o
difficulty breathing
o
chills
o
dizziness
o
numbness and tingling
o
changes in your sense of touch (hypoesthesia)
severe allergic and skin reactions.
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 healthcare provider about all the medicines you take.

The Most Common Side Effects Of Cresemba Include: 

nausea
vomiting
diarrhea
headache
changes in the level of a liver enzyme in your blood
low potassium
back pain
shortness of breath
cough
swelling of arms or legs
constipation

Tell your 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 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 notremove CRESEMBA from original packaging until your scheduled dose.
Do notput CRESEMBA in pill boxes or pill organizers.
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 healthcare professionals.

For more information go towww.CRESEMBA.comor call 1-800-727-7003.

Active Ingredient: 

isavuconazonium sulfate

Inactive Ingredients: 

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

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


Marketed and Distributed by:
Astellas Pharma US, Inc.
Northbrook, IL 60062

CRESEMBAis a registered trademark of Astellas Pharma Inc.

Licensed from: Basilea Pharmaceutica International Ltd.

205935-ISA

Revised: 4/2018

Patient Information 

Advise patients to read the FDA-approved patient labeling (Patient Information).

Advise patients that CRESEMBA can be taken with or without food. Each capsule should be swallowed whole. Do not chew, crush, dissolve, or open the capsules.

Advise patients to inform their physician if they are taking other drugs or before they begin taking other drugs as certain drugs can decrease or increase the plasma concentrations of CRESEMBA.

CRESEMBA can decrease or increase the plasma concentrations of other drugs.

Advise patients to inform their physician if they are pregnant, plan to become pregnant, or are nursing.

Product of Portugal

Marketed and Distributed by:
Astellas Pharma US, Inc.
Northbrook, IL 60062

CRESEMBAis a registered trademark of Astellas Pharma Inc.

Licensed from: Basilea Pharmaceutica International Ltd.

205935-ISA

Revised: 4/2018



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