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Indications of Eltrombopag

1.Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia

Eltrombopag is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

2.Treatment of Thrombocytopenia in Patients With Hepatitis C Infection

Eltrombopag is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.

3.Treatment of Severe Aplastic Anemia

Eltrombopag is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.

Eltrombopag is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

4 Limitations of Use

Eltrombopag is not indicated for the treatment of patients with myelodysplastic syndromes (MDS).

Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

from FDA,2021.10

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