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

Interactions
PK
Renal impairment
References

Eltrombopag

Generic name
Eltrombopag
Brand name
ATC Code
B02BX05

Pharmacokinetics in children

 

AgeCmax (mcg/ml)AUC (mcg.hour/ml)
1-5 years (n=38) 11.6 (10.4–12.9) 162 (139–187)
6-11 years (n=68) 10.3 (9.42–11.2) 153 (137–170)
12-17 years (n=62) 6.8 (6.17–7.5) 103 (91.1–116)

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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

Primary, refractory immune thrombocytopenic purpura (ITP)
  • Oral
    • 1 year up to 6 years
      • Initially: 25 mg/day in 1 dose. Max: 75 mg/day. In patients of East/Southeast Asian descent: no dose reduction in this age group On a paediatric haematologist’s prescription.
        • Adjust if necessary depending on the thrombocyte count:
        Blood platelet count            Dose adjustment or response
        < 50,000/µl after at least 2 weeks of treatment Increase the daily dose by 25 mg up to a maximum of 75 mg/day (in patients using 25 mg every other day, increase to 25 mg/day)
        > 50,000/µl - < 150,000/µl  Use the lowest possible dose of eltrombopag and/or additional ITP treatment to keep the blood platelet count at a level that prevents or reduces bleeding
        > 150,000/µl - < 250,000/µl Lower the daily dose by 25 mg. Wait 2 weeks to determine the result before switching to any further dose adjustments. (in patients using 25 mg/day, 12.5 mg/day or 25 mg every other day)
        > 250,000/µl Stop eltrombopag and increase the frequency of the blood platelet checks to twice a week. Resume treatment with eltrombopag at a lowered daily dose (25 mg less) as soon as the blood platelet count is < 100.000/µl.
        • Weekly monitoring of liver function until stable dosage has been achieved. After that monthly monitoring (see warnings and precautions) [Expert opinion of the Benign Haematology Section, 2019]
        • Exclusively on a paediatric haematologist’s prescription
    • 6 years up to 18 years
      • Initially: 50 mg/day in 1 dose. Max: 75 mg/day. In patients of East/Southeast Asian descent:
        Start : 25 mg/day in 1 dose On a paediatric haematologist’s prescription.

      • Adjust if necessary depending on the thrombocyte count:

        Blood platelet count            Dose adjustment or response
        < 50,000/µl after at least 2 weeks of treatment Increase the daily dose by 25 mg up to a maximum of 75 mg/day (in patients using 25 mg every other day, increase to 25 mg/day)
        > 50,000/µl - < 150,000/µl  Use the lowest possible dose of eltrombopag and/or additional ITP treatment to keep the blood platelet count at a level that prevents or reduces bleeding
        > 150,000/µl - < 250,000/µl Lower the daily dose by 25 mg. Wait 2 weeks to determine the result before switching to any further dose adjustments. (in patients using 25 mg/day, 12.5 mg/day or 25 mg every other day)
        > 250,000/µl Stop eltrombopag and increase the frequency of the blood platelet checks to twice a week. Resume treatment with eltrombopag at a lowered daily dose (25 mg less) as soon as the blood platelet count is < 100.000/µl.
        • Weekly monitoring of liver function until stable dosage has been achieved. After that monthly monitoring (see warnings and precautions) [Expert opinion of the Benign Haematology Section, 2019]
        • Exclusively on a paediatric haematologist’s prescription

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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

Very common (> 10%): upper respiratory tract infections, coughing

Common (1-10%) : rhinorrhea, toothache, 

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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

- A few cases of acute liver failure in children have been reported (including Marano 2018). This is possibly due to a different drug metabolism of the liver. Genotyping can be considered.

- Eltrombopag can discolour the plasma, which can interfere with laboratory tests.

 

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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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Vitamin K
B02BA01
Fibrinogen
B02BB01
Local hemostatics
B02BC30
Blood coagulation factors
B02BD08
B02BD04
B02BD02
B02BD01
Other systemic hemostatics
B02BX06
B02BX04
Blood coagulation factors
B02BD08
B02BD04
B02BD02
B02BD01

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References

  1. Novartis Europharm Limited, SmPC Revolade (EU1/10/612/001-013), Rev 31, 04-11-2022, www.geneesmiddeleninformatiebank.nl
  2. Wire MB et al., Modeling and Simulation Support Eltrombopag Dosing in Pediatric Patients With Immune Thrombocytopenia, Clin Pharmacol Ther., 2018, Dec;104(6), 1199-1207
  3. Marano M et al., Eltrombopag-induced acute liver failure in a pediatric patient: a pharmacokinetic and pharmacogenetic analysis., Ther Drug Monit., 2018, Aug;40(4), 386-388
  4. Sectie Benigne Hematologie, Expertopinie controle op leverfunctie bij elthrombopag gebruik - 16-04-2019

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Changes

Changes