Isavuconazonium (oral/injection)

Isavuconazonium is used in adults and children who are at least 1 year old to treat infections caused by certain types of fungus (aspergillosis or mucormycosis).

Isavuconazonium capsule is used only in adults and children who are at least 6 years old and weigh at least 35 pounds (16 kg).

Isavuconazonium may also be used for reasons not mentioned in this medication guide.

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

Your doctor will decide the best formulation for you based on your condition.

Isavuconazonium oral is taken by mouth. Isavuconazonium injection is given as an infusion into a vein. A healthcare provider may give you this injection or may teach you how to use this medicine by yourself.

Isavuconazonium injection can also be given through a nasogastric tube. Your healthcare provider will administer this medicine.

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

Do not give isavuconazonium capsule through a nasogastric tube.

Prepare an injection only when you are ready to use it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it. Ask your doctor or pharmacist if you do not understand these instructions.

Make sure you know how to properly mix the isavuconazonium injection with a liquid (diluent) and how to store the mixture.

You will need medical tests to check your liver and heart function before and during treatment with isavuconazonium.

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

Follow all storage instructions provided with isavuconazonium. Your healthcare provider can give you more information about how to store this medicine.

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

Tell your doctor about all your other medicines. Some drugs should not be used with 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 drugs should not be used with isavuconazonium. Your treatment plan may change if you also use:

• carbamazepine;
• ketoconazole;
• long-acting barbiturates such as phenobarbital;
• rifampin;
• lopinavir and ritonavir (at high doses); or
• St. John's wort.

Tell your doctor if you have or have ever had:

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

May harm an unborn baby. Use effective birth control while using isavuconazonium and for at least 28 days after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using isavuconazonium.

Get emergency medical help if you have signs of an allergic reaction (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 happen during the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Isavuconazonium may cause serious side effects. Call your doctor immediately if you have:

• liver problems—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of isavuconazonium may include:

• nausea, vomiting, diarrhea, constipation, stomach pain;
• rash, itching;
• 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.

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 dayComments:-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 dayComments:-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

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.

• Avoid taking an herbal supplement containing St. John's wort.

Sometimes, using certain medicines together can be unsafe. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medicines work.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect isavuconazonium, especially:

• medicine to prevent organ transplant rejection--cyclosporine, sirolimus, tacrolimus.

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