- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The pediatric dosing regimens were determined using a PopPK model. The predicted exposures with the pediatric dosing regimen were lower than the exposures for adults receiving multiple daily supratherapeutic doses of 600 mg isavuconazole.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Invasive aspergillosis; mucormycosis |
|---|
|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Overall, the safety profile of isavuconazole in pediatric patients was similar to that in adults.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
Congenital short QT-time syndrome.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Antibiotics | ||
|---|---|---|
| J02AA01 | ||
| J02AA01 | ||
| J02AA01 | ||
| J02AA01 | ||
| Triazole and tetrazole derivatives | ||
|---|---|---|
| J02AC01 | ||
| J02AC02 | ||
| J02AC04 | ||
| J02AC03 | ||
| Other antimycotics for systemic use | ||
|---|---|---|
| J02AX06 | ||
| J02AX04 | ||
| J02AX01 | ||
| J02AX05 | ||
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Reference
- Basilea Pharmaceutica Deutschland GmbH, SmPC Cresemba (EU/1/15/1036) Rev 19; 11-09-2024, www.ema.europa.eu
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Changes
Changes
