Drug updated on 12/11/2024
| 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 (odds ratio (OR) = 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 (relative risk (RR) = 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 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 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 |