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

Interactions
PK
Renal impairment
References

Idarubicin

Generic name
Idarubicin
Brand name
ATC Code
L01DB06

Pharmacokinetics in children

The following pharmacokinetic parameters were found after 3 days on 40 mg/m² orally:
t½: 9.2 hours (6.4–25.5 hours)
Cmax: 10.6 ng/ml (2.7-16.7 ng/ml)
the t½ values for oral and intravenous administration are comparable; they do however differ from the t½ in adults. The Cmax values for adults and children after oral administration are comparable. The clearance is faster in adults than in children.
 

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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

Oncological conditions
  • Intravenous
    • 0 years up to 18 years

      • Note:
        The dose and dosing frequency of cytostatic agents depend on the condition and are very much subject to new insights. Cytostatic drugs are mostly used in oncology and haematology in combinations. For this reason, please refer to the detailed treatment protocols.

        The following indicative dosages have been stated by the manufacturer:
        ALL: 10 mg/m²/day IV for 3 days
        AML: 10-12 mg/m²/day IV for 3 days combined with cytarabine.

         

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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

Children are susceptible to anthracycline-induced cardiotoxicity

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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 in children

Extravasation: Immediately apply cold compresses, for at least 6 hours. Repeat this for 1 week, 4 times daily for 20 minutes. In serious cases, wound excision may be required. The urine may be coloured red.

Due to the greater susceptibility to anthracycline-induced cardiotoxicity in children, the heart function should be monitored periodically for a lengthy period.     
 
General cytostatic: a range of cytostatics can trigger hypersensitivity reactions. An emergency set (containing epinephrine, clemastine and hydrocortisone) should be present in the treatment room. The emergency set also contains specific antidotes.

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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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Anthracyclines and related substances
L01DB02
L01DB01
L01DB07
Other cytotoxic antibiotics
L01DC01
OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
L01FX06

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Pfizer BV, SPC Zavedos (RVG 14201) 21-01-2014, www.cbg-meb.nl, Geraadpleegd 14-04-2014

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Changes

Changes