Isavuconazonium

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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.

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.

Serious side effects have been reported with isavuconazonium including the following:

• liver problems
• infusion-related reactions, including decreased blood pressure, chills, dizziness, and a sensation of tingling or burning of the skin
• hypersensitivity reactions, including severe skin reactions or difficulty breathing

Isavuconazonium can cause dizziness. Do not drive or operate heavy machinery until you know how isavuconazonium affects you.

Do not take isavuconazonium if you:

• are allergic to isavuconazonium or to any of its ingredients
• are taking drugs that interact with isavuconazonium, such as ketoconazole, high-dose ritonavir, rifampin, carbamazepine, St. John's Wort, or phenobarbital

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if isavuconazonium crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using isavuconazonium.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have

The recommended starting dose of oral and intravenous isavuconazonium for treating fungal infections is 372 mg every 8 hours for 6 doses. After the first 6 doses, the recommended dose of isavuconazonium is 372 mg once daily.

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.

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody urine
• blurred vision
• chest pain
• confusion
• convulsions
• decreased frequency or amount of urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• loss of appetite
• lower back or side pain
• muscle pain or cramps
• muscle spasms (tetany) or twitching
• numbness or tingling in the hands, feet, or lips
• seizures
• severe nausea or vomiting
• sweating
• tightness in the chest
• tingling of the hands or feet
• trembling
• trouble breathing
• unusual tiredness or weakness

• Cough or hoarseness
• dark urine
• fever with or without chills
• hives, itching, or rash
• irritation
• joint pain, stiffness, or swelling
• light-colored stools
• red, swollen skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• yellow eyes and skin

• Blistering, peeling, or loosening of the skin
• chills
• diarrhea
• red skin lesions, often with a purple center
• red, irritated eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• anxiety
• back pain
• headache
• heartburn or indigestion
• seeing, hearing, or feeling things that are not there
• stomach discomfort or upset
• trouble sleeping
• unusual excitement, nervousness, or restlessness

• Continuing ringing or buzzing or other unexplained noise in the ears
• decreased vision
• eye pain
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• hearing loss
• sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.