Drug updated on 11/4/2024
| 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
- This summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-14]
- In severe aplastic anemia (SAA), eltrombopag combined with immunosuppressive therapy (IST) showed a significantly higher overall response rate (ORR) at 3 months (OR (odds ratio) = 2.10) and 6 months (OR = 2.13), with no significant difference by 12 months (OR = 1.13). The complete response rate (CRR) was similarly higher at 3 months (OR = 2.73) and 6 months (OR = 2.76), but not at 12 months (OR = 1.38). The overall survival rate (OSR) was improved (OR = 1.70), with a higher relapse rate in the experimental group (54% vs. 39%).
- Eltrombopag as a single agent led to blood count improvement in 40-50% of severe aplastic anemia patients.
- In immune thrombocytopenic purpura (ITP), eltrombopag resulted in a significantly better platelet response compared to placebo in adults (RR (relative risk) = 3.65) but not in children (RR = 3.93). Comparative effectiveness showed avatrombopag had better platelet response in adults, and romiplostim ranked higher overall in network meta-analyses.
- Eltrombopag achieved a durable platelet response and reduced the need for concomitant ITP medications relative to placebo, though avatrombopag and romiplostim were often ranked higher in comparative studies.
- In severe aplastic anemia (SAA), no significant differences in event-free survival rate (EFSR) or clonal evolution rate were observed between eltrombopag combined with immunosuppressive therapy and immunosuppressive therapy alone.
- For immune thrombocytopenic purpura (ITP), no significant increase in thrombotic events was noted with eltrombopag treatment, and the safety profile was similar to that of romiplostim and avatrombopag regarding adverse events.
- Specific adverse effects included increased pigment deposition and abnormal liver function with eltrombopag in combination with immunosuppressive therapy; a lower incidence of bleeding was observed in children treated with eltrombopag.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Promacta (eltrombopag) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |