Isavuconazonium Sulfate for Injection

Excipients: mannitol, sulfuric acid (for pH adjustment)

[Properties] This product is a white to yellow block.

[Indications] This product is suitable for the treatment of the following infections in adult patients:

• Invasive aspergillosis

• Invasive mucormycosis

[Specifications] 200mg (calculated as C22H17F2N5OS)

[Usage and Dosage] Dosage

Specimens for fungal culture and other related laboratory studies (including histopathology) should be obtained before starting antifungal treatment to isolate and identify pathogenic microorganisms. Early targeted treatment (preemptive treatment or diagnosis-driven treatment) can be started while waiting for specific diagnostic tests to confirm the disease. However, after the results are available, antifungal treatment should be adjusted accordingly.

Loading dose: Recommended loading dose: one bottle (equivalent to 200 mg of isavuconazole) every 8 hours within the first 48 hours, administered after reconstitution and dilution, for a total of 6 doses.

Maintenance dose: Recommended maintenance dose: One bottle (equivalent to 200 mg isavuconazole) once daily starting 12 to 24 hours after the last loading dose, administered after reconstitution and dilution.

The duration of treatment should be determined based on clinical response (see [Clinical Trials]).

For long-term treatment of more than 6 months, the benefit-risk balance should be carefully considered (see [Clinical Trials] and [Pharmacology and Toxicology]).

Interchangeability between oral capsules and intravenous infusion: This product is also available in capsule form, each containing 100 mg isavuconazole. (See “Instructions for Use of Isavuconazole Sulfate Capsules” for use)

Due to the high bioavailability of the oral dosage form (98%, see [Pharmacokinetics]), the two routes of administration, intravenous infusion and oral administration, can be interchanged when clinically indicated.

Use in special populations

Elderly: No dose adjustment is required for elderly patients; however, clinical experience with elderly patients is limited.

Renal impairment: No dose adjustment is required for patients with renal impairment (including patients with end-stage renal disease) (see [Pharmacokinetics]).

Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh class A and B) (see [Precautions], [Pharmacokinetics]).

Isavuconazole has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Its use in these patients is not recommended unless the potential benefits are considered to outweigh the risks (see [Precautions], [Adverse Reactions], [Pharmacokinetics]).

Pediatric population: The safety and efficacy of this product for minors under 18 years of age have not been established. No data are available.