Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Dasatinib

Generic name
Dasatinib
Brand name
ATC Code
L01XE06

Pharmacokinetics in children

The following kinetic parameters were found in children aged 2-20 years [Aplenc 2011]:

Dose n= Cmax Tmax T½
50 mg/m² 4 77 ng/ml 1.66 hours 2.6 hours
65 mg/m² 4 155 ng/ml 1 hour 2.7 hours
85 mg/m² 6 146 ng/ml 1.76 hours 1.9 hours
110 mg/m² 4 250 ng/ml 2.26 hours 3.6 hours

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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, resistant or intolerant Ph+ CML in the chronic phase; Ph+ ALL
  • Oral
    • 1 year up to 18 years
      [1] [2] [3] [4]

      • 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 (national) treatment protocols:

        The following indicative dosages have been stated in the SmPC:

        Body weight Dose (SUSPENSION) Dose (TABLETS)
        5 to 10 kg 40 mg/day in 1 dose use suspensie 
        10 to 20 kg 60 mg/day in 1 dose 40 mg/day in 1 dose
        20 to 30 kg 90 mg/day in 1 dose 60 mg/day in 1 dose
        30 to 45 kg 105 mg/day in 1 dose 70 mg/day in 1 dose
        ≥ 45 kg 120 mg/day in 1 dose 100 mg/day in 1 dose

        The dose should be adjusted based on clinical response and toxicity (see SmPC)

        Treatment by or after consultations with a paediatric specialist (oncologist) who has experience using dasatinib for this indication.
Resistant/intolerant/recurrent CML in accelerated or blast phase
  • Oral
    • Tablet
      • 1 year up to 18 years
        [1] [2] [3]

        • 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 national treatment protocols 

          The following indicative dosages have been stated in the literature:
          - 80 mg/m²/day in a single dose, max 180 mg/dose.
          In cases of toxicity, lower the dosage to 65 mg/m², max 110 mg/dose. If necessary, lower it further to 50 mg/m², max 80 mg/dose.

          Treatment by or after consultations with a paediatric specialist (oncologist) who has experience using dasatinib for this indication.
CAUTION:
  • Route of administration not applicable
    • 0 years up to 18 years

      • Please note that the tablets and suspension are NOT bioequivalent and therefore not directly interchangeable. They each have their own dosage regimen.

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Renal impaiment in children > 3 months

The dose does not need to be adjusted for renal function disorders.

 

Patients on dialysis

No generalized recommendations are given.

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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

Common (1-10%): in Ph+ CML in the chronic phase delayed fusion of the epiphyses, growth retardation and sometimes (0.1-1%) in Ph+ ALL osteopenia. Otherwise, the safety profile is generally similar to that of adults.[SmPC]

Growth retardation [Hobernicht 2011, 8. Watanabe 2013]

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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

Check the total blood count regularly after starting the therapy (once every 1-2 weeks).
Consider TDM if side effects occur.

Growth retardation in children: has been reported. It is therefore recommended to monitor growth and bone development in children.

 

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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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Methylhydrazines
L01XB01
PROTEINEKINASEREMMERS
L01XE01
Other antineoplastic agents
L01XX02
L01XX05
L01XX24

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References

  1. Aplenc R et al. , Pediatric phase I trial and pharmacokinetic study of dasatinib: a report from the children's oncology group phase I consortium., J Clin Oncol. , 2011 , Mar 1;29(7), 839-44
  2. Matloub J et al, A Phase II Study of Dasatinib Therapy in Children and Adolescents with Ph+ Leukemia with Resistance or Intolerance to Imatinib. Clinical Trial Protocol CA180226. , www.skion.nl
  3. Zwaan CM et al. , Dasatinib in children and adolescents with relapsed or refractory leukemia: results of the CA180-018 phase I dose-escalation study of the Innovative Therapies for Children with Cancer Consortium., J Clin Oncol. , 2013, Jul 1;31(19), 2460-8
  4. Bristol-Myers Squibb Pharma EEIG. , SmPC Sprycel (EU/1/06/363) Rev41, 17-06-2022, www.ema.europa.eu
  5. Hobernicht SL et al. , Acquired growth hormone deficiency in a girl with chronic myelogenous leukemia treated with tyrosine kinase inhibitor therapy., Pediatr Blood Cancer., 2011 , Apr;56(4), 671-3
  6. Watanabe A et al. , Prophylactic post-transplant dasatinib administration in a pediatric patient with Philadelphia chromosome-positive acute lymphoblastic leukemia., Pediatr Int., 2013 , Jun;55(3), e56-8

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Changes

Changes