Olapag-50

Publish Date: 13-Feb-2024

Each Film Coated Tablet Contains Eltrombopag 50 mg (as Eltrombopag Olamine INN). 

Indications: 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. 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. 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. 

Dosage & administration: Chronic Immune Thrombocytopenia: Use the lowest dose of Eltrombopag to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use Eltrombopag to normalize platelet counts (see Warnings and Precautions). In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting Eltrombopag and decreased within 1 to 2 weeks after discontinuing Eltrombopag. Initial Dose Regimen: Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are East-/Southeast Asian ancestry or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C). For patients of East-/Southeast Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate, or severe hepatic impairment(Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients of East-/Southeast Asian ancestry with ITP and hepatic impairment(Child-Pugh Class A,B,C)., consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily. Storage: Store below 30°C in a dry place. Packing: Each box contains 28 tablets in blister pack.