Cresemba (isavuconazonium) is an antifungal medication that fights infections caused by fungus.
Cresemba is used to treat infections caused by certain types of fungus (aspergillosis or mucormycosis).
Cresemba may also be used for purposes not listed in this medication guide.
Important information
You should not use Cresemba if you have a genetic heart rhythm disorder called "Short QT syndrome."
Many drugs can interact with isavuconazonium, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Cresemba.
Before taking this medicine
You should not use Cresemba if you are allergic to isavuconazonium, or if you have:
Some medicines can cause unwanted or dangerous effects when used with Cresemba. Your doctor may need to change your treatment plan if you use any of the following drugs:
To make sure Cresemba is safe for you, tell your doctor if you have:
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liver disease;
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a heart rhythm disorder; or
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history of an allergic reaction to antifungal medicine, such as fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole.
Using Cresemba during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.
It is not known whether isavuconazonium passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Cresemba.
How should I take Cresemba?
Take Cresemba exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Cresemba is available in a capsule form, and also in an injectable form.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Cresemba is first given in a "loading dose" every 8 hours for 48 hours. You will then use the medicine once daily as your "maintenance dose." Follow your doctor"s dosing instructions very carefully.
You may take the capsule with or without food.
Do not crush, chew, open, or dissolve the Cresemba capsule. Swallow it whole.
Store the capsules at room temperature, away from moisture and heat. Keep the capsules in their original blister pack, along with the packet or canister of moisture-absorbing preservative. Do not put Cresemba capsules into a daily pill box or pill organizer.
The injectable form of Cresemba is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Cresemba injection is a powder medicine that must be mixed with a liquid (diluent) before using it. You will then need to further dilute this mixture into a solution with another liquid in an IV bag. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.
Each single-use vial (bottle) of the powder is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Store the dry unmixed powder medicine in a refrigerator. After you mix the powder and diluent, keep the mixture in a refrigerator for up to 1 hour before further diluting it. If you store the final diluted solution in a refrigerator, use it within 24 hours after it was mixed. Do not freeze this medicine before or after mixing.
You may also store the final diluted solution at cool room temperature, but you must use it within 6 hours after mixing.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
You will need frequent blood tests to check your liver function.
Do not stop using Cresemba unless your doctor tells you to.
Cresemba dosing information
Usual Adult Dose of Cresemba for Aspergillosis - Invasive:
Loading Dose: 372 mg IV or orally every 8 hours for 6 doses (48 hours)
Maintenance Dose: 372 mg IV or orally once a day
Comments:
-Isavuconazonium sulfate is the prodrug of isavuconazole; 372 mg of isavuconazonium sulfate is equivalent to 200 mg of isavuconazole.
-Maintenance doses should be started 12 to 24 hours after the last loading dose.
Usual Adult Dose for Mucormycosis - Invasive:
Loading Dose: 372 mg IV or orally every 8 hours for 6 doses (48 hours)
Maintenance Dose: 372 mg IV or orally once a day
Comments:
-Isavuconazonium sulfate is the prodrug of isavuconazole; 372 mg of isavuconazonium sulfate is equivalent to 200 mg of isavuconazole.
-Maintenance doses should be started 12 to 24 hours after the last loading dose.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of Cresemba.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include dizziness, drowsiness, hot flashes, headache, joint pain, anxiety, feeling restless, numbness or tingling, trouble concentrating, dry mouth, altered sense of taste, numbness in or around your mouth, diarrhea, vomiting, and fast or pounding heartbeats.
What should I avoid while using Cresemba?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Cresemba side effects
Get emergency medical help if you have signs of an allergic reaction to Cresemba: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, chilled, or have any numbness, tingling, or changes in your sense of touch.
Call your doctor at once if you have:
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling; or
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severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Cresemba side effects may include:
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nausea, vomiting, diarrhea, constipation;
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swelling in your arms or legs;
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headache, back pain;
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cough, trouble breathing;
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low potassium; or
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abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Cresemba?
Sometimes it is not safe to use certain medications at the same time. Some drugs can raise or lower your blood levels of Cresemba, which may cause side effects or make this medicine less effective. Isavuconazonium can also affect blood levels of certain other drugs, making them less effective or increasing side effects.
Many drugs can interact with isavuconazonium. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
This list is not complete and many other drugs can interact with isavuconazonium. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
