- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information
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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
- GFR ≥ 30: dose adjustment is not needed
- GFR 10-30: 50-75% of normal reversal dose, adjustment of dosing interval is not needed.
- GFR <10: 50% of normal reversal dose, adjustment of dosing interval is not necessary.
Clinical consequences
With impaired renal function, the clearance of bleomycin decreases. This increases the risk of toxicity.
Clinical Effects:
The most important side effect is interstitial pneumonia which occurs in approximately 10% of patients and may progress to irreversible pulmonary fibrosis. The risk of pulmonary toxicity increases with the cumulative dose. The most common side effects are (incidence up to 50%) impairment of skin and mucous membranes. Flagellate pigmentation with linear hyperpigmentation and itching (incidence 8-38%) is dose-related.
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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: cooling with a cold compress is recommended.
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 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
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Changes
Changes
