Active Ingredient: Eltrombopag
Eltrombopag is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Eltrombopag is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
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 75 milligrams eltrombopag, once daily. The maximum allowed total dose is 75 milligrams eltrombopag daily.
Regimen B: Oral, 25 milligrams eltrombopag, once daily, over the duration of 2 weeks. Afterwards, oral, between 25 milligrams eltrombopag and 75 milligrams eltrombopag, once daily. The maximum allowed total dose is 75 milligrams eltrombopag daily.
The lowest dose of eltrombopag to achieve and maintain a platelet count ≥50 000/μl should be used. Dose adjustments are based upon the platelet count response. Eltrombopag must not be used to normalise platelet counts. In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag and decreased within 1 to 2 weeks after discontinuation.
The recommended starting dose of eltrombopag is 50 mg once daily. For patients of East-/Southeast-Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily.
After initiating eltrombopag, the dose must be adjusted to achieve and maintain a platelet count ≥50 000/μl as necessary to reduce the risk for bleeding. A daily dose of 75 mg must not be exceeded. Clinical haematology and liver tests should be monitored regularly throughout therapy with eltrombopag and the dose regimen of eltrombopag modified based on platelet counts as outlined in Table 1. During therapy with eltrombopag full blood counts (FBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50 000/μl for at least 4 weeks) has been achieved. FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter.
Table 1. Dose adjustments of eltrombopag in ITP patients:
| Platelet count | Dose adjustment or response |
|---|---|
| <50 000/μl following at least 2 weeks of therapy | Increase daily dose by 25 mg to a maximum of 75 mg/day*. |
| ≥50 000/μl to ≤150 000/μl | Use lowest dose of eltrombopag and/or concomitant ITP treatment to maintain platelet counts that avoid or reduce bleeding. |
| >150 000/μl to ≤250 000/μl | Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments♦. |
| >250 000/μl | Stop eltrombopag; increase the frequency of platelet monitoring to twice weekly. Once the platelet count is ≤100 000/μl, reinitiate therapy at a daily dose reduced by 25 mg. |
* For patients taking 25 mg eltrombopag once every other day, increase dose to 25 mg once daily.
♦ For patients taking 25 mg eltrombopag once daily, consideration should be given to dosing at 12.5 mg once daily or alternatively a dose of 25 mg once every other day.
Eltrombopag can be administered in addition to other ITP medicinal products. The dose regimen of concomitant ITP medicinal products should be modified, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag.
It is necessary to wait for at least 2 weeks to see the effect of any dose adjustment on the patient’s platelet response prior to considering another dose adjustment.
The standard eltrombopag dose adjustment, either decrease or increase, would be 25 mg once daily.
Treatment with eltrombopag should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of eltrombopag therapy at 75 mg once daily.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician. In non-splenectomised patients this should include evaluation relative to splenectomy. The reoccurrence of thrombocytopenia is possible upon discontinuation of treatment.
There are limited data on the use of eltrombopag in ITP patients aged 65 years and older and no clinical experience in ITP patients aged over 85 years. In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between patients aged at least 65 years and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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).
For:
Regimen A: In case that patient age in years is ≥ 1 and patient age in years is ≤ 5, oral, 25 milligrams eltrombopag, once daily.
Regimen B: In case that patient age in years is ≥ 6, oral, 50 milligrams eltrombopag, once daily.
The lowest dose of eltrombopag to achieve and maintain a platelet count ≥50 000/μl should be used. Dose adjustments are based upon the platelet count response. Eltrombopag must not be used to normalise platelet counts. In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag and decreased within 1 to 2 weeks after discontinuation.
The recommended starting dose of eltrombopag is 50 mg once daily. For patients of East-/Southeast-Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily.
The recommended starting dose of eltrombopag is 25 mg once daily.
After initiating eltrombopag, the dose must be adjusted to achieve and maintain a platelet count ≥50 000/μl as necessary to reduce the risk for bleeding. A daily dose of 75 mg must not be exceeded. Clinical haematology and liver tests should be monitored regularly throughout therapy with eltrombopag and the dose regimen of eltrombopag modified based on platelet counts as outlined in Table 1. During therapy with eltrombopag full blood counts (FBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50 000/μl for at least 4 weeks) has been achieved. FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter.
Table 1. Dose adjustments of eltrombopag in ITP patients:
| Platelet count | Dose adjustment or response |
|---|---|
| <50 000/μl following at least 2 weeks of therapy | Increase daily dose by 25 mg to a maximum of 75 mg/day*. |
| ≥50 000/μl to ≤150 000/μl | Use lowest dose of eltrombopag and/or concomitant ITP treatment to maintain platelet counts that avoid or reduce bleeding. |
| >150 000/μl to ≤250 000/μl | Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments♦. |
| >250 000/μl | Stop eltrombopag; increase the frequency of platelet monitoring to twice weekly. Once the platelet count is ≤100 000/μl, reinitiate therapy at a daily dose reduced by 25 mg. |
* For patients taking 25 mg eltrombopag once every other day, increase dose to 25 mg once daily.
♦ For patients taking 25 mg eltrombopag once daily, consideration should be given to dosing at 12.5 mg once daily or alternatively a dose of 25 mg once every other day.
Eltrombopag can be administered in addition to other ITP medicinal products. The dose regimen of concomitant ITP medicinal products should be modified, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag.
It is necessary to wait for at least 2 weeks to see the effect of any dose adjustment on the patient’s platelet response prior to considering another dose adjustment.
The standard eltrombopag dose adjustment, either decrease or increase, would be 25 mg once daily.
Treatment with eltrombopag should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of eltrombopag therapy at 75 mg once daily.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician. In non-splenectomised patients this should include evaluation relative to splenectomy. The reoccurrence of thrombocytopenia is possible upon discontinuation of treatment.
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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