Isavuconazol

Generic name
Isavuconazol
Brand name
ATC Code
J02AC05
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Isavuconazol

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.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Invasive aspergillosis; mucormycosis
  • Intravenous
    • ≥ 1 year
      • Initial dose: 16.2 mg/kg/day in 3 doses. Max: 200 mg/dose. (6 administrations in total).
      • Maintenance dose: 12-24 after the last starting dose: 5.4 mg/kg/day in 1 dose. Max: 200 mg/dose.
  • Oral
    • 16 up to 18 kg
      • Initial dose: 240 mg/day in 3 doses. (6 administrations in total).
      • Maintenance dose: 12-24 hours after last starting dose: 80 mg/day in 1 dose
    • 18 up to 25 kg
      • Initial dose: 360 mg/day in 3 doses. (6 administrations in total).
      • Maintenance dose: 12-24 hours after last starting dose: 120 mg/day in 1 dose
    • 25 up to 32 kg
      • Initial dose: 480 mg/day in 3 doses. (6 administrations in total).
      • Maintenance dose: 12-24 hours after last starting dose: 160 mg/day in 1 dose
    • 32 up to 37 kg
      • Initial dose: 540 mg/day in 3 doses. (6 administrations in total).
      • Maintenance dose: 12-24 hours after last starting dose: 180 mg/day in 1 dose
    • ≥ 37 kg
      • Initial dose: 600 mg/day in 3 doses. (6 administrations in total).
      • Maintenance dose: 12-24 hours after last starting dose: 200 mg/day in 1 dose

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.

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.

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.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIMYCOTICS FOR SYSTEMIC USE

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
J02AA01
J02AA01
J02AA01
J02AA01
Triazole and tetrazole derivatives
J02AC01
J02AC02
J02AC04
J02AC03
Other antimycotics for systemic use
J02AX06
J02AX04
J02AX01
J02AX05

Reference

  1. Basilea Pharmaceutica Deutschland GmbH, SmPC Cresemba (EU/1/15/1036) Rev 19; 11-09-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose