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Pronunciation: EYE sa vue KOE na ZOE nee um

Brand: Cresemba

What is the most important information I should know about isavuconazonium?

You should not use this medicine if you have a genetic heart rhythm disorder called short QT syndrome."

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

What is isavuconazonium?

Isavuconazonium is used to treat infections caused by certain types of fungus (aspergillosis or mucormycosis).

Isavuconazonium may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using isavuconazonium?

You should not use isavuconazonium if you are allergic to it, or if you have:

  • a genetic heart rhythm disorder called short QT syndrome.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with isavuconazonium. Your doctor may change your treatment plan if you also use:

  • carbamazepine;
  • ketoconazole;
  • phenobarbital;
  • rifampin;
  • ritonavir (at high doses); or
  • St. John's wort.

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.

Isavuconazonium may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 28 days after your last dose. Tell your doctor if you become pregnant.

You should not breastfeed while using isavuconazonium.

Isavuconazonium is not approved for use by anyone younger than 18 years old.

How should I take isavuconazonium?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Isavuconazonium oral is taken by mouth. Isavuconazonium 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.

You may take the isavuconazonium capsule with or without food. Swallow the capsule whole and do not crush, chew, break, or open it.

Isavuconazonium 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 if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You will need frequent blood tests to check your liver function.

Do not stop using isavuconazonium unless your doctor tells you to.

Store the capsules in their original blister pack at room temperature, away from moisture and heat. Do not put the capsules into a daily pill box or pill organizer.

Store unused vials in a refrigerator. After mixing the diluent into a vial, keep the vial at room temperature and further dilute the mixture in an IV bag within 1 hour. After mixing the final solution, keep the IV bag at room temperature and use it within 6 hours or store the bag in a refrigerator and use it within 24 hours. Do not freeze.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

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 isavuconazonium?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of isavuconazonium?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult 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, difficult breathing, chilled, or have any numbness, tingling, or changes in your sense of touch.

Call your doctor at once if you have:

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

Common side effects may include:

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

What other drugs will affect isavuconazonium?

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.

Tell your doctor about all your current medicines. Many drugs can affect isavuconazonium, especially:

  • digoxin; or
  • medicine to prevent organ transplant rejection (cyclosporine, sirolimus, tacrolimus).

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

Where can I get more information?

Your pharmacist can provide more information about isavuconazonium.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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