Active Ingredient: Eltrombopag
Eltrombopag is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 50 milligrams eltrombopag, once daily, over the duration of 2 weeks. Afterwards, oral, between 50 milligrams eltrombopag and 150 milligrams eltrombopag, once daily. The maximum allowed total dose is 150 milligrams eltrombopag daily.
Regimen B: Oral, 25 milligrams eltrombopag, once daily, over the duration of 2 weeks. Afterwards, oral, between 25 milligrams eltrombopag and 150 milligrams eltrombopag, once daily. The maximum allowed total dose is 150 milligrams eltrombopag daily.
Eltrombopag should be initiated at a dose of 50 mg once daily. For patients of Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily. The treatment should not be initiated when the patients has existing cytogenetic abnormalities of chromosome 7.
Haematological response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting eltrombopag. The dose of eltrombopag should be adjusted in 50 mg increments every 2 weeks as necessary to achieve the target platelet count ≥50,000/µl. For patients taking 25 mg once daily, the dose should be increased to 50 mg daily before increasing the dose amount by 50 mg. A dose of 150 mg daily must not be exceeded. Clinical haematology and liver tests should be monitored regularly throughout therapy with eltrombopag and the dosage regimen of eltrombopag modified based on platelet counts as outlined in the followinh table.
Dose adjustments of eltrombopag in patients with severe aplastic anaemia:
| Platelet count | Dose adjustment or response |
|---|---|
| <50 000/μl following at least 2 weeks of therapy | Increase daily dose by 50 mg to a maximum of 150 mg/day. For patients taking 25 mg once daily, increase the dose to 50 mg daily before increasing the dose amount by 50 mg. |
| ≥50 000/μl to ≤150 000/μl | Use lowest dose of eltrombopag to maintain platelet counts. |
| >150 000/μl to ≤250 000/μl | Decrease the daily dose by 50 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments. |
| >250 000/μl | Stop eltrombopag; for at least one week. Once the platelet count is ≤100 000/μl, reinitiate therapy at a daily dose reduced by 50 mg. |
For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks: the dose of eltrombopag may be reduced by 50%.
If counts remain stable after 8 weeks at the reduced dose, then eltrombopag must be discontinued and blood counts monitored. If platelet counts drop to <30,000/µl, haemoglobin drops to <9 g/dl or absolute neutrophil count (ANC) <0.5 × 109/l, eltrombopag may be reinitiated at the previous effective dose.
If no haematological response has occurred after 16 weeks of therapy with eltrombopag, therapy should be discontinued. If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate. Excessive platelet count responses (as outlined in the above table) or important liver test abnormalities also necessitate discontinuation of eltrombopag.
Eltrombopag should be taken at least two hours before or four hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations (e.g. iron, calcium, magnesium, aluminium, selenium and zinc).
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