Cresemba

Generic name: Isavuconazonium Sulfate
Dosage form: oral capsule, injection for intravenous or nasogastric use
Drug class: Azole antifungals

Usage of Cresemba

Cresemba (isavuconazonium sulfate) is an antifungal medication that may be used to treat invasive fungal infections caused by aspergillosis or mucormycosis in adults and children. It is available as a capsule or as an injection for intravenous administration with the following restrictions:

  • The injection may be given to adults and children 1 year of age and older The capsules may be given to adults and children 6 years of age and older who weigh at least 16 kilograms (kg) or more.  

    • Cresemba (isavuconazonium sulfate) works by inhibiting the manufacture of ergosterol, which is a key component of the fungal cell membrane. It does this by inhibiting a cytochrome P-450-dependent enzyme called lanosterol 14-alpha-demethylase. This enzyme is responsible for the conversion of lanosterol to ergosterol. Without ergosterol, the fungal cell wall becomes weakened and is unable to function properly, causing cell death. Cresemba is a prodrug, so in the body, isavuconazonium sulfate is converted to isavuconazole, the active ingredient. Human cells are less sensitive to the effects of isavuconazole.

    Cresemba was FDA-approved on March 6, 2015, and belongs to the class of medicines known as azole antifungal agents.

    Cresemba side effects

    Get emergency medical help if you have signs of an allergic reaction to Cresemba (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

    Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, difficulty breathing, chilled, or have any numbness, tingling, or changes in your sense of touch.

    Call your doctor at once if you have:

  • liver problems, symptoms may include loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
  • low potassium levels, symptoms may include leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness, or limp feeling.

    • Common Cresemba side effects may include:

  • nausea, vomiting, diarrhea, or constipation
  • swelling in your arms or legs
  • headache or back pain
  • cough or shortness of breath
  • low potassium or
  • abnormal liver function tests.

    • Side effects such as abdominal pain, rash, and itchy skin more commonly occur in children. 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 the FDA at 1-800-FDA-1088.

    Before taking Cresemba

    Tell your doctor about any known allergies you have or if you take any medications. You should not use Cresemba if you are allergic to isavuconazonium or any of the inactive ingredients.

    To make sure Cresemba is safe for you, tell your doctor if you have ever had:

  • liver disease
  • a heart rhythm disorder or history of an allergic reaction to antifungal medicine, such as fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole
  • are pregnant, intending to become pregnant, or breastfeeding.

    • Pregnancy and breastfeeding

    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 dose. Talk to your healthcare provider about birth control methods that may be right for you.

    Cresemba can pass into your breast milk and may harm your baby and you should not breastfeed while using it. Talk to your healthcare provider about the best way to feed your baby during treatment.

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    How to use Cresemba

    Take it exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Do not stop using Cresemba unless your doctor tells you to.

  • Your healthcare provider will calculate the correct dosage for you.

    • Capsules

  • Cresemba capsules are taken by mouth.
  • May be taken with or without food.
  • Swallow the capsule whole and do not crush, chew, break, or open it.

    • Injection

    Cresemba injection is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

  • The injection must be mixed with a liquid (diluent) and then further diluted in an IV bag before using it. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
  • Prepare an injection only when you are ready to give it. Do not use it if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
  • Administer through an in-line filter over a minimum of 1 hour.

    • Warnings

    Anaphylactic reactions, some of which were fatal, have been reported during treatment with Cresemba. Other potential hypersensitivity reactions include serious skin reactions, such as Stevens-Johnson syndrome, which have been reported with other azole antifungal agents. Discontinue Cresemba if an anaphylactic or serious skin reaction occurs, and tell your healthcare provider immediately.

    Do not take Cresemba if you or your child:

  • are allergic to Cresemba, isavuconazonium sulfate, or any of the inactive ingredients. are taking any of the following medicines: ketoconazole o rifampin o St. John’s wort (herbal supplement) phenobarbital high-dose ritonavir o carbamazepine o long-acting barbiturates have a genetic problem that affects the electrical system of the heart (familial short QT syndrome).

    • Serious liver toxicity has been reported with Cresemba. Your healthcare provider will monitor your liver function before starting treatment and during treatment.

    Infusion-related reactions have occurred during the intravenous administration of Cresemba. Your healthcare provider will stop the infusion if these occur.

    Cresemba may cause fetal harm and should not be administered to a pregnant woman.

    What other drugs will affect Cresemba

    Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Many drugs can interact with Cresemba (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, especially:

  • ketoconazole
  • phenobarbital
  • rifampin
  • ritonavir (at high doses) or
  • St. John's wort
  • carbamazepine
  • long-acting barbiturates
  • digoxin or
  • medications used to prevent organ transplant rejection (such as cyclosporine, sirolimus, tacrolimus).

    • This list is not complete and many other drugs may interact with isavuconazonium. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. 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.

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