Nilotinib

Generic name
Nilotinib
Brand name
ATC Code
L01EA03
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Newly diagnosed Ph+ CML in chronic phase; Resistant/intolerant Ph+ CML in acceleration phase or chronic phase; recurrent or refractory Ph+ ALL
  • Oral
    • 0 years up to 18 years
      [1]

      • The dosage and dosing frequency of oncological agents depend on the condition and are very much subject to new insights. Oncological drugs are often used in combinations. For this reason, please refer to the detailed treatment protocols (see www.skion.nl)

        The following indicative dosages have been stated in the literature:

        • 460 mg/m² in 2 doses.

        Treatment by or after consultations with a paediatric specialist (oncology) who has experience using nilotinib for this indication.

      • Directions for administration:

        take at least 2 hours after eating and then wait 1 hour before eating again to avoid variation in absorption.

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.

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

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.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Anthracyclines and related substances
L01DB02
L01DB01
Other cytotoxic antibiotics
L01DC01

References

  1. 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
  2. Novartis europharm Limited., SmPC Tasigna rev 37 30-03-2020, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose