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.

You should not use isavuconazonium 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.

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.

Usual Adult Dose 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.

Uses: For the treatment of invasive aspergillosis and invasive mucormycosis

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.

Uses: For the treatment of invasive aspergillosis and invasive mucormycosis

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.

Call your doctor for instructions if you miss a dose.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Isavuconazonium comes in blister packaging and each blister section has two pockets. The left pocket has a desiccant (small packet that contains a substance that absorbs moisture to keep the medication dry) and the right pocket has the medication. Only open the isavuconazonium pocket and leave the desiccant in the packaging. Do not remove isavuconazonium from the original packaging until you are ready to take your dose. Do not put isavuconazonium in pill boxes or pill organizers. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

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

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.

Isavuconazonium may cause serious side effects. 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 of isavuconazonium 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to isavuconazonium.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.