Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; 12.5 mg, 25 mg, 50 mg, and 75 mg); Suspension (oral; 12.5 mg, 25 mg) |
| Drug Class | Thrombopoietin receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- 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.
- For the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Summary
- Eltrombopag (Promacta) is indicated for the treatment of thrombocytopenia in adult and pediatric patients with persistent or chronic immune thrombocytopenia, chronic hepatitis C, and severe aplastic anemia. It has shown significant improvement in platelet counts without increasing bleeding or adverse effects compared to placebo.
- Information provided comes from 8 systematic reviews/meta-analyses focusing on evaluating eltrombopag's efficacy, safety, and comparison against other treatments for these conditions.
- In terms of the safety profile among Thrombopoietin receptor agonists (TPO-RAs), eltrombopag does not significantly increase the risk of thrombotic events. A study involving 1,698 ITP patients showed no significant difference in this risk between TPO-RA-treated groups and controls.
- For pediatric patients with severe aplastic anemia (SAA), combining eltrombopag with immunosuppressive therapy shows promise, but results are mixed; hence, cautious interpretation is advised when considering its use within this subgroup.
- Subgroup analysis indicates a higher potential for increased thrombotic risks among elderly patients as well as those with a history of thrombus formation. Therefore, careful monitoring should be implemented for these populations.
- Compared to other treatments such as avatrombopag and romiplostim used for treating chronic ITP patients through network meta-analysis studies, all three drugs were effective at increasing platelet response rates, with no statistically significant advantage over one another despite some metrics showing romiplostim being slightly more effective than Promacta.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Promacta (eltrombopag) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation., East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| A practical guide to the use of eltrombopag in children with chronic immune thrombocytopenia. | 2017 | Pediatric Hematology and Oncology |