Eltrom 25 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Eltrombopag olamine |
| Company | Jenphar bangladesh ltd |
| Also available as |
Indications
- Treatment of thrombocytopenia in patients with persistent or chronic immune thrombocytopenia
- Treatment of thrombocytopenia in patients with hepatitis C infection
- Treatment of severe aplastic anemia
Pharmacology
Eltrombopag Olamine is a small molecule thrombopoietin (TPO) receptor agonist. Eltrombopag interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells finally leading to increased platelet production.
Dosage & Administration
- Route of administration: Oral
- Recommended dose for persistent or chronic immune thrombocytopenia: The lowest dose to achieve and maintain a platelet count greater than or equal to 50x10^9/L as necessary to reduce the risk for bleeding. Not to exceed a dose of 75 mg daily.
- Dose for adult and pediatric patients with ITP: Initiate at a dose of 50 mg once daily, with reduced dose for patients of Asian ancestry or those with mild to severe hepatic impairment.
- Dose for pediatric patients with ITP aged 1 to 5 years: Initiate at a dose of 25 mg once daily.
- Dose for chronic hepatitis C associated thrombocytopenia: Initiate at a dose of 25 mg once daily, with adjustments every 2 weeks as necessary. Not to exceed a dose of 100 mg daily.
- Dose for first line severe aplastic anemia: Dose depends on the patient's age and hepatic impairment, with modifications based on platelet counts, ALT or AST elevations, and thromboembolic events.
- Dose for refractory severe aplastic anemia: Initiate at 50 mg once daily, with adjustments every 2 weeks. Not to exceed a dose of 150 mg per day.
Interaction
- Drug interaction with medication: Take eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids and mineral supplements.
- Drug interaction with food and others: Take eltrombopag at least 2 hours before or 4 hours after any calcium rich foods.
Contraindications
Eltrombopag is contraindicated in patients with known hypersensitivity to eltrombopag or any components of this product.
Side Effects
- Anemia
- Nausea
- Pyrexia
- ALT increased
- Cough
- Fatigue
- Headache
- Diarrhea
Pregnancy & Lactation
No sufficient data is available to assess any drug-associated risks for major birth defects, miscarriage or adverse maternal or fetal outcomes. Breastfeeding is not recommended during treatment.
Precautions & Warnings
- Chronic hepatitis C: May increase the risk of hepatic decompensation. Monitor liver function.
- Myelodysplastic syndromes: Increased risk of death and progression to acute myeloid leukemia.
- Portal vein thrombosis: Monitor platelet counts regularly.
Use in Special Populations
- Use in children and adolescents: Safety and efficacy in pediatric patients below the age of 1 year with ITP have not been established. Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and refractory severe aplastic anemia have not been established.
Overdose Effects
In the event of overdose, platelet counts may increase excessively and result in thrombotic or thromboembolic complications. Consider oral administration of a metal cation containing preparation to chelate eltrombopag and limit absorption.
Therapeutic Class
Haemostatic drugs
Storage Conditions
Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.