Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 12.5 mg, 25 mg, 50 mg, and 75 mg); Oral suspension (oral; 12.5 mg, 25 mg) |
| Drug Class | Thrombopoietin receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
- Indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA 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.
- Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
- Indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Latest News
Summary
- Promacta (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; the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy; the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia in combination with standard immunosuppressive therapy; and the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- Immune Thrombocytopenic Purpura (ITP): Eltrombopag significantly improved platelet response in adults (RR, 3.65; 95% CI, 2.39-5.55) and reduced bleeding in children (RR, 0.47; 95% CI, 0.27-0.83).
- Severe Aplastic Anemia (SAA): Eltrombopag combined with IST increased overall response rate at 3 and 6 months (OR at 3 months = 2.73, 95% CI 1.83-4.09).
- Chemotherapy-Induced Thrombocytopenia (CIT): Thrombopoietic agents, including eltrombopag, did not significantly affect chemotherapy dose delays/reductions, grade 3/4 thrombocytopenia, platelet transfusions, or bleeding events.
- Immune Thrombocytopenic Purpura (ITP): No significant increase in thromboembolic events was observed in patients treated with eltrombopag compared to controls (OR=2.32, 95% CI: 0.64-8.47, P=0.20). The incidence of adverse events was similar to placebo in adults (RR, 0.99; 95% CI, 0.55-1.78) and in children (RR, 0.99; 95% CI, 0.25-1.49).
- Severe Aplastic Anemia (SAA): No significant increase in clonal evolution or other adverse events was observed when eltrombopag was added to IST, with a good safety profile in the pediatric population.
- General Thrombopoietic Agents: There was no evidence of an increased risk of thrombosis with thrombopoietic agents, including eltrombopag.
- Eltrombopag shows increased thrombotic risk in ITP patients with advanced age or a history of thrombosis, while efficacy and safety outcomes are mixed in pediatric populations, especially in SAA with IST and ITP, showing heterogeneity by age. No gender-specific differences were reported.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Promacta (eltrombopag) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |