Active Ingredient: Isavuconazole
Isavuconazole is indicated in adults and in paediatric patients from 6 years of age for the treatment of 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:
For:
Intravenous, 200 milligrams isavuconazole, once every 8 hours, over the duration of 48 hours. Afterwards, intravenous, 200 milligrams isavuconazole, once hourly.
Early targeted therapy (pre-emptive or diagnostic-driven therapy) may be instituted pending confirmation of the disease from specific diagnostic tests. However, once these results become available, antifungal therapy should be adjusted accordingly.
Detailed information on dosage recommendations is provided in the following table:
Dosage recommendation:
| Loading dose (every 8 hours for the first 48 hours)1 | Maintenance dose (once daily)2 | |
| Adults | 200 mg isavuconazole | 200 mg isavuconazole |
1 Six administrations in total.
2 Maintenance dose: Starting 12 to 24 hours after the last loading dose.
Duration of therapy should be determined by the clinical response (see section 5.1).
For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered.
On the basis of the high oral bioavailability (98%), switching between intravenous and oral administration is appropriate when clinically indicated.
No dose adjustment is necessary for elderly patients; however, the clinical experience in elderly patients is limited.
Isavuconazole solution must be reconstituted and then further diluted to a concentration corresponding to a range of 0.4 to 0.8 mg/mL prior to administration by intravenous infusion over a minimum of 1 hour to reduce the risk of infusion-related reactions. Higher concentrations should be avoided as these may cause local irritation at the site of infusion. 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.
For:
Oral, 200 milligrams isavuconazole, once every 8 hours, over the duration of 2 days. Afterwards, oral, 200 milligrams isavuconazole, once daily.
Early targeted therapy (pre-emptive or diagnostic-driven therapy) may be instituted pending confirmation of the disease from specific diagnostic tests. However, once these results become available, antifungal therapy should be adjusted accordingly.
Detailed information on dosage recommendations is provided in the following tables:
Recommended dosage for isavuconazole in adult patients:
| Loading dose (three times daily) | Maintenance dose (once daily)1 | |
| every 8 hours during Days 1 and 2 | total daily dose during Days 1 and 2 | |
| 200 mg | 600 mg | 200 mg |
1 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.
On the basis of the high oral bioavailability (98%), switching between intravenous and oral administration is appropriate when clinically indicated.
No dose adjustment is necessary for elderly patients; however, the clinical experience in elderly patients is limited.
It can be taken with or without food.
For:
Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≥ 16 kg and patient weight is < 18 kg, oral, 80 milligrams isavuconazole, once every 8 hours, over the duration of 2 days. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 16 kg and patient weight is < 18 kg, oral, 80 milligrams isavuconazole, once hourly.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 18 kg and patient weight is < 25 kg, oral, 120 milligrams isavuconazole, once every 8 hours, over the duration of 2 days. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 18 kg and patient weight is < 25 kg, oral, 120 milligrams isavuconazole, once daily.
Regimen C: In case that patient age in years is ≥ 6 and patient weight is ≥ 25 kg and patient weight is < 32 kg, oral, 160 milligrams isavuconazole, once every 8 hours, over the duration of 2 days. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 25 kg and patient weight is < 32 kg, oral, 160 milligrams isavuconazole, once daily.
Regimen D: In case that patient age in years is ≥ 6 and patient weight is ≥ 32 kg and patient weight is < 37 kg, oral, 180 milligrams isavuconazole, once every 8 hours, over the duration of 2 days. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 32 kg and patient weight is < 37 kg, oral, 180 milligrams isavuconazole, once daily.
Regimen E: In case that patient age in years is ≥ 6 and patient weight is ≥ 37 kg, oral, 200 milligrams isavuconazole, once every 8 hours, over the duration of 2 days. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 37 kg, oral, 200 milligrams isavuconazole, once hourly.
Early targeted therapy (pre-emptive or diagnostic-driven therapy) may be instituted pending confirmation of the disease from specific diagnostic tests. However, once these results become available, antifungal therapy should be adjusted accordingly.
Recommended dosage for isavuconazole in paediatric patients aged from 6 years to less than 18 years:
| Bodyweight (kg) | Loading dose (three times daily) | Maintenance dose (once daily)1 | |
| every 8 hours during Days 1 and 2 | total daily dose during Days 1 and 2 | ||
| 16 kg to <18 kg | 80 mg | 240 mg | 80 mg |
| 18 kg to <25 kg | 120 mg | 360 mg | 120 mg |
| 25 kg to <32 kg | 160 mg | 480 mg | 160 mg |
| 32 kg to <37 kg | 180 mg | 540 mg | 180 mg |
| ≥37 kg | 200 mg | 600 mg | 200 mg |
1 Starting 12 to 24 hours after the last loading dose.
The maximum of any individual loading or daily maintenance dose to be administered to any patient is 200 mg isavuconazole.
All capsules per dose must be taken at the same time.
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.
Paediatric patients from one year to below 6 years of age, or with a bodyweight less than 16 kg, or are not able to swallow the oral form of isavuconazole may receive isavuconazole as intravenous infusion.
On the basis of the high oral bioavailability (98%), switching between intravenous and oral administration is appropriate when clinically indicated.
It can be taken with or without food.
For:
Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≥ 37 kg, intravenous, 200 milligrams isavuconazole, once every 8 hours, over the duration of 48 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 37 kg, intravenous, 200 milligrams isavuconazole, once every 8 days.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is < 37 kg, intravenous, 5.4 milligrams isavuconazole per kilogram of body weight, once every 8 hours, over the duration of 48 hours. Afterwards, in case that patient age in years is ≥ 6 and patient weight is < 37 kg, intravenous, 5.4 milligrams isavuconazole per kilogram of body weight, once daily.
Early targeted therapy (pre-emptive or diagnostic-driven therapy) may be instituted pending confirmation of the disease from specific diagnostic tests. However, once these results become available, antifungal therapy should be adjusted accordingly.
Detailed information on dosage recommendations is provided in the following table:
Dosage recommendation:
| Loading dose (every 8 hours for the first 48 hours) | Maintenance dose (once daily)1 | |
| Paediatric patients aged from 1 year to less than 18 years | ||
| Bodyweight ≥37 kg | 200 mg isavuconazole | 200 mg isavuconazole |
| Bodyweight <37 kg | 5.4 mg/kg isavuconazole | 5.4 mg/kg isavuconazole |
1 Maintenance dose: Starting 12 to 24 hours after the last loading dose.
The maximum of any individual loading or daily maintenance dose to be administered to any paediatric patient is 200 mg isavuconazole.
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.
Isavuconazole solution must be reconstituted and then further diluted to a concentration corresponding to a range of 0.4 to 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. Higher concentrations should be avoided as these may cause local irritation at the site of infusion. 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.
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