- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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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
There is insufficient evidence to give concrete recommendations. There are two handbooks that give recommendations for ifosfamide in cases of reduced renal function. These differ from one another, however:
1. Drug Prescribing in Renal Failure, 5th ed., paediatric table:
• GFR 30-50 ml/min: 100%
• GFR 10-29 ml/min: 100%
• GFR < 10 ml/min: 75%
2. The Renal Drug Handbook, 4th ed., adults:
• GFR > 60 ml/min: 80% of the normal dose
• GFR 30-60 ml/min: 80% of the normal dose
• GFR 15-30 ml/min: 80% of the normal dose
• GFR < 15 ml/min: 60% of the standard dose
Information
There have been no studies of the use of ifosfamide in patients with reduced renal function. Ifosfamide is an inactive prodrug; it is only effective after hydrolysis by CYP3A4. Ifosfamide is excreted mainly with the urine, with 14-34% of it in unchanged form. It is likely that reduced renal function affects the clearance of ifosfamide.
Clinical consequences
Dose-related side effects: inter alia abnormal blood counts, such as leukopenia.
Haemorrhagic cystitis occurs in 1-10% of patients. Haemorrhagic cystitis is caused by a high concentration of the toxic metabolite acrolein in the bladder. Reduction of renal function has been observed in approx. 4% of cases. Renal impairment is especially related to the tubular system. In children in particular, the abnormalities can be irreversible and Fanconi syndrome can arise.
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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: Await developments, cool with ice if necessary.
The risk of haemorrhagic cystitis is reduced by administering mesna, substantial diuresis and alkalization of the urine.
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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| Nitrogen mustard analogues | ||
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| L01AA01 | ||
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Reference
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
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Changes
Changes
