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.

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.

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Comments:

• This drug should be used in patients with severe liver dysfunction only if the benefits outweigh the risks.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component
• Coadministration with strong CYP450 3A4 inhibitors (e.g., ketoconazole, high-dose ritonavir [400 mg every 12 hours])
• Coadministration with strong CYP450 3A4 inducers (e.g., rifampin, carbamazepine, long-acting barbiturates, St. John's wort)
• Familial short QT syndrome

Dialysis

ESRD: No adjustment recommended.

Other Comments

Administration advice:

• Administer IV formulation via an infusion set with an in-line filter (pore size 0.2 to 1.2 micron).
• Infuse the IV formulation over a minimum of 1 hour in 250 mL of compatible diluent (to reduce risk for infusion-related reactions); do not administer as IV bolus injection.
• Do not infuse with any other IV drugs.
• Flush IV lines with 0.9% sodium chloride injection, USP or 5% dextrose injection, USP before and after infusion.
• Avoid unnecessary vibration or vigorous shaking of the diluted IV solution; do not use a pneumatic transport system.
• May switch between IV and oral formulations (bioequivalent); no loading dose needed when switching between formulations.
• Swallow capsules whole; do not chew, crush, dissolve, or open capsules.
• Administer capsules with or without food.
• For nasogastric (NG) tube administration, administer the reconstituted injection solution within 1 hour of reconstitution.
• To administer, connect the syringe containing the reconstituted solution to the NG tube to deliver the dose.
• After administering the dose, administer 3 rinses (5 mL each) with water to the NG tube.

• Capsules: Store at 20C to 25C (68F to 77F) in the original bottle to protect from moisture; excursion permitted to 15C to 30C (59F to 86F).
• Injection (unreconstituted vials): Store at 2C to 8C (36F to 46F) in refrigerator.
• Injection (reconstituted solution): Should use immediately
• For IV administration: May be stored below 25C up to 1 hour before preparation of the patient IV infusion solution
• For NG tube administration: Should administer within 1 hour of reconstitution
• Injection (diluted IV infusion solution): Complete iv infusion within 6 hours of dilution at room temperature (20C to 25C [68F to 77F]); if this is not possible, refrigerate (2C to 8C [36F to 46F]) the infusion solution immediately after dilution and complete the IV infusion within 24 hours; do not freeze.

• For IV administration of the injection formulation: Requires reconstitution and then dilution before infusion
• For NG tube administration of the injection formulation: Requires reconstitution before administration
• The manufacturer product information should be consulted.

• Compatible diluents: 0.9% sodium chloride injection, USP; 5% dextrose injection, USP

• Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained before therapy to isolate and identify causative organisms; therapy may be started before results are known, but once available, antifungal therapy should be adjusted accordingly.

• General: For drug-related side effects in patients with severe liver dysfunction
• Hepatic: Liver-related laboratory tests (at the start of and during therapy); for more severe hepatic injury in patients with abnormal liver-related laboratory tests (during therapy)

• Read the US FDA-approved patient labeling (Patient Information).