- 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
No information
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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
| Newly diagnosed Ph+ CML in chronic phase; Resistant/intolerant Ph+ CML in acceleration phase or chronic phase; recurrent or refractory Ph+ ALL |
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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
Hepatoxicity and growth retardation
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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
In children, determine a complete blood count every 1-2 weeks during the first 2 months of treatment and at least monthly thereafter.
Children have a higher risk of hepatotoxicity. Liver function (bilirubin and transaminases) check monthly or if indicated. If liver impairment occurs, discontinue treatment temporarily, reduce the dose, or discontinue treatment. Growth retardation may occur during treatment with nilotinib. Keep a close eye on growth.
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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 | ||
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| L01DB02 | ||
| L01DB01 | ||
| Other cytotoxic antibiotics | ||
|---|---|---|
| L01DC01 | ||
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References
- Veronica C et al. , A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ CML<....>, Clinical trial protocol CAMN107A2203. www.skion.nl
- Novartis europharm Limited., SmPC Tasigna rev 37 30-03-2020, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
