[en Español]


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."

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 isavuconazonium.

What is isavuconazonium?

Isavuconazonium is an antifungal medication that fights infections caused by fungus.

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."

Some medicines can cause unwanted or dangerous effects when used with isavuconazonium. Your doctor may need to change your treatment plan if you use any of the following drugs:

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

To make sure isavuconazonium is safe for you, tell your doctor if you have:

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

Using isavuconazonium 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 this medicine.

How should I take isavuconazonium?

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.

Isavuconazonium 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.

Isavuconazonium 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 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 isavuconazonium capsules into a daily pill box or pill organizer.

The injectable form of isavuconazonium 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.

Isavuconazonium 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 isavuconazonium unless your doctor tells you to.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of isavuconazonium.

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 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:

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

  • nausea, vomiting, diarrhea, constipation;
  • swelling in your arms or legs;
  • headache, back pain;
  • cough, trouble breathing;
  • 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 raise or lower your blood levels of isavuconazonium, which may cause side effects or make isavuconazonium 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:

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

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.

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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