Zomacta
Eltrombopag Olamine Tablets
Strength
✓25 mg✓50 mg
Pack Size
Tablet
Drug Class
Antihemorrhagics, other systemic hemostatics
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration.
Eltrombopag olamine is a biphenyl hydrazone.
Chemical name
3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2)
Molecular formula
C25H22N4O4 • 2(C2H7NO)
Molecular weight
- 564.65 g/mol for eltrombopag olamine
- 442.5 g/mol for eltrombopag free acid
Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4 and is sparingly soluble in water.
1. Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia: Indicated for treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had insufficient response to:
- corticosteroids
- immunoglobulins
- splenectomy
2. Treatment of Thrombocytopenia in Patients With Hepatitis C Infection: Indicated for thrombocytopenia in patients with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy.
3. Treatment of Severe Aplastic Anemia
- Indicated in combination with standard immunosuppressive therapy for first-line treatment
- Also indicated in patients with insufficient response to immunosuppressive therapy
Limitations of Use
- Not indicated for treatment of myelodysplastic syndromes (MDS)
- Safety and efficacy not established with direct-acting antiviral agents used without interferon
Eltrombopag is used to treat low platelet levels in adults and children at least 1 year old with chronic immune thrombocytopenia after other treatments stopped working or did not work.
Eltrombopag is also used to treat low platelet levels in adults with chronic hepatitis C before and during interferon therapy.
It is also used together with other medicines as starting treatment for severe aplastic anemia in adults and children at least 2 years old.
Eltrombopag is also used in adults to treat severe aplastic anemia after other treatments did not work or stopped working.
- In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase risk of hepatic decompensation.
- Eltrombopag may increase risk of severe and potentially life-threatening hepatotoxicity.
- Hepatic function should be monitored regularly.
- Discontinue dosing if recommended by physician.
Eltrombopag treatment should be initiated and supervised by a physician experienced in haematological diseases or chronic hepatitis C management.
Dose requirements must be individualized based on platelet counts.
Objective of treatment
- To achieve and maintain platelet count ≥50,000/µL
- Not to normalize platelet counts
Immune (primary) thrombocytopenia
Adults and paediatric population aged 6 to 17 years:
- Recommended starting dose:
- 50 mg once daily
- For East-/Southeast-Asian ancestry:
- Initiate at reduced dose of 25 mg once daily
Paediatric population aged 1 to 5 years
- Recommended starting dose:
- 25 mg once daily
Platelet counts generally
- Increase within 1 to 2 weeks after starting therapy
- Decrease within 1 to 2 weeks after discontinuation