- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
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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
| Oncological conditions |
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Renal impaiment in children > 3 months
at a creatinine clearance of > 50 ml/min/1.73m²
no dose adjustment required
at a creatinine clearance of 30-50 ml/min/1.73m²
50% of the normal dose, then dose depending on the blood counts
at a creatinine clearance of less than 30 ml/min/1.73m²
contraindicated (see below)
There are two case reports known in which a child with renal function of < 30 ml/min was successfully treated with fludarabine.
1. Heitink-Pollé 2008 (Wilhelmina Children’s Hospital, Utrecht)
Girl (5 yrs) with Fanconi anaemia, chronic renal impairment (creatinine clearance 22 ml/min/1.73m²). because of a bone marrow transplant: fludarabine at 15 mg/m² for 3 days + thoracoabdominal irradiation (not the kidneys). This was instead of the normal regimen: fludarabine at 30 mg/m² for 5 days + Cytoxan + ATG. Cytoxan was replaced because of the risk of toxicity in reduced renal function.
2. Turkistani 2010 (Saudi Arabia)
Girl (2 yrs) with Fanconi anaemia, chronic renal impairment (creatinine clearance estimated at 17 ml/min/1.73m² and 12 ml/min/1.73m² based on 24-hour urine). Because of a stem cell transplant: fludarabine at 15 mg/m² for 3 days + Cytoxan + ATG. This was instead of the normal regimen: fludarabine at 30 mg/m² for 5 days + Cytoxan + ATG. The Cytoxan was also adjusted because of the reduced renal function!
Information
In reduced renal function, the AUC of the active metabolite increases. The risk of side effects is elevated as a result.
Clinical consequences
Dose-related side effects include bone marrow depression (that can become severe), nausea (primarily in oral administration) and stomatitis.
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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 in children
Extravasation: The nature of any reactions on extravasation is unknown.
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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| Purine analogues | ||
|---|---|---|
| L01BB06 | ||
| L01BB02 | ||
| L01BB07 | ||
| L01BB03 | ||
| Pyrimidine analogues | ||
|---|---|---|
| L01BC01 | ||
| L01BC52 | ||
| L01BC05 | ||
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Reference
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
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Changes
Changes
