Eltrombopag

Generic name
Eltrombopag
Brand name
ATC Code
B02BX05
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Eltrombopag

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

Interactions
PK
Renal impairment
References

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)

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

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.

      • 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. Start : 25 mg/day in 1 dose in patients of East/Southeast Asian descent  .

      • 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

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

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

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

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.

 

Interactions

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

VITAMIN K AND OTHER HEMOSTATICS

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

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

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

Changes

Therapeutic Drug Monitoring


Overdose