Invasive aspergillosis, mucormycosis

Active Ingredient: Isavuconazole

Indication for Isavuconazole

Population group: only adults (18 years old or older)

Isavuconazole is indicated in adults for the treatment of:

  • invasive aspergillosis
  • mucormycosis in patients for whom amphotericin B is inappropriate

Consideration should be given to official guidance on the appropriate use of antifungal agents.

For this indication, competent medicine agencies globally authorize below treatments:

200-600 mg in 1-3 divided doses daily

Route of admnistration

Intravenous

Defined daily dose

200 - 600 mg

Dosage regimen

From 66.667 To 200 mg 3 time(s) per day every day

Loading dose

600 mg

Maintenance dose

200 mg

Detailed description

The recommended loading dose is 200 mg of isavuconazole every 8 hours for the first 48 hours (6 administrations in total).

Maintenance dose

The recommended maintenance dose is 200 mg of isavuconazole once daily, starting 12 to 24 hours after the last loading dose.

Duration of therapy should be determined by the clinical response.

For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered.

Dosage considerations

Isavuconazole must be reconstituted and then further diluted to a concentration corresponding to approximately 0.8 mg/mL isavuconazole prior to administration by intravenous infusion over a minimum of 1 hour to reduce the risk of infusion-related reactions. The infusion must be administered via an infusion set with an in-line filter with a microporous membrane made of polyethersulfone (PES) and with a pore size of 0.2 μm to 1.2 μm. Isavuconazole must only be given as an intravenous infusion.

200-600 mg in 1-3 divided doses daily

Route of admnistration

Oral

Defined daily dose

200 - 600 mg

Dosage regimen

From 66.667 To 200 mg 3 time(s) per day every day

Loading dose

600 mg

Maintenance dose

200 mg

Detailed description

The recommended loading dose is 200 mg of isavuconazole every 8 hours for the first 48 hours (6 administrations in total).

Maintenance dose

The recommended maintenance dose is 200 mg of isavuconazole once daily, starting 12 to 24 hours after the last loading dose.

Duration of therapy should be determined by the clinical response.

For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered.

Dosage considerations

Isavuconazole must be reconstituted and then further diluted to a concentration corresponding to approximately 0.8 mg/mL isavuconazole prior to administration by intravenous infusion over a minimum of 1 hour to reduce the risk of infusion-related reactions. The infusion must be administered via an infusion set with an in-line filter with a microporous membrane made of polyethersulfone (PES) and with a pore size of 0.2 μm to 1.2 μm. Isavuconazole must only be given as an intravenous infusion.

Active ingredient

Isavuconazole

Isavuconazole is an active form of isavuconazonium. Isavuconazole inhibits lanosterol 14-alpha demethylase (or CYP51A1) and leads to the accumulation of ergosterol toxic precursors in the fungal cytoplasm. Isavuconazole is indicated for the treatment of invasive aspergillosis and invasive mucormycosis.

Read more about Isavuconazole

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