Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Mitotane

Generic name
Mitotane
Brand name
ATC Code
L01XX23

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Adrenal cortex carcinoma
  • Oral
    • 1 month up to 18 years

      • The dosage and dosing frequency of oncological agents depend on the condition and are very much subject to new insights. Oncological drugs are often used in combinations. For this reason, please refer to the detailed treatment protocols (see www.skion.nl). Indicative dosages have been stated by the manufacturer:

        Initially: 1.5-3.5 g/m²/day in 2-3 doses, gradually increase to 4 g/m²/day until plasma levels of 14-20 mg/l are attained. Lower the dose after 2-3 months, based on plasma concentrations.

      • Directions for administration:

        Take with food that contains fat

      • The plasma concentration should be checked every 2 weeks during treatment, weekly in the case of high starting doses, and every 2 months after interruptions of the treatment.

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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

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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

No information available on specific contra indications in children.

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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Methylhydrazines
L01XB01
MONOKLONALE ANTILICHAMEN
L01XC11
L01XC18
L01XC18
Other antineoplastic agents
L01XX01
L01XX02
L01XX05
L01XX24
L01XX14
Proteasome inhibitors
L01XG01
Antineoplastic cell and gene therapy
L01XL04

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Reference

  1. Laboratoire HRA Pharma, SmPC Lysodren (EU/1/04/273/001) 04-05-2015, www.geneesmiddeleninformatiebank.nl

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Changes

Changes