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Isavuconazonium Sulfate for injection is supplied in a single-dose vial as a
sterile lyophilized powder containing 372 mg of Isavuconazonium Sulfate (equivalent to 200 mg of isavuconazole). Isavuconazonium Sulfate capsules: contains 74.5 mg of Isavuconazonium Sulfate (equivalent to 40 mg of isavuconazole), and 186 mg of Isavuconazonium Sulfate (equivalent to 100 mg of isavuconazole).

Isavuconazonium Sulfate is an antifungal that is used to treat:

• Invasive aspergillosis (a serious fungal infection affecting multiple areas of the body)
• Invasive mucormycosis (a serious fungal infection affecting multiple areas of the body)

Isavuconazonium Sulfate is an antifungal. It kills the fungus causing your infection by damaging its protective outer layer.

Isavuconazonium Sulfate is dosed as follows:

• Dosing for IV infusion: Infuse 1 vial (372 mg) of Isavuconazonium Sulfate through an IV line every 8 hours for 6 doses (this is the first 2 days of medication). After that, infuse 1 vial (372 mg) through an IV line once daily
• Dosing for capsules: Take 2 capsules (372 mg) of Isavuconazonium Sulfate by mouth every 8 hours for 6 doses (this is the first 2 days of medication). After that, take 2 capsules (372 mg) by mouth once daily

Isavuconazonium Sulfate is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• Hypersensitivity to Isavuconazonium Sulfate. Coadministration with strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir
• Coadministration with strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John’s wort, or long acting barbiturates
• Use in patients with familial short QT syndrome

Common side effects of Isavuconazonium Sulfate:

• Nausea
• Vomiting
• Diarrhea
• Headache
• Changes to liver blood tests
• Low potassium levels
• Constipation
• Trouble breathing
• Cough
• Swelling of the limbs
• Back pain

Serious side effects are rare with Isavuconazonium Sulfate. Contact your healthcare provider immediately if you experience any of the following.

• Allergic reactions
• Life-threatening skin reactions
• Liver failure

The following medications may interact with Isavuconazonium Sulfate:

• CYP3A4 inhibitors or inducers may alter the plasma concentrations of isavuconazole
• Appropriate therapeutic drug monitoring and dose adjustment of immunosuppressants (i.e., tacrolimus, sirolimus, and cyclosporine) may be necessary when coadministered with Isavuconazonium Sulfate
• Drugs with a narrow therapeutic window that are P-gp substrates such as digoxin, may require dose adjustment when administered concomitantly with Isavuconazonium Sulfate

Various FDA-approved generic manufacturers

Isavuconazonium Sulfate may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Women who can become pregnant should use effective birth control while taking Isavuconazonium Sulfate and for 28 days after the last Isavuconazonium Sulfate dose. Talk to your healthcare
provider about birth control methods that may be right for you.

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