Drug updated on 5/17/2024
| 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.
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Summary
- Eltrombopag (Promacta) is indicated for the treatment of thrombocytopenia in adult and pediatric patients with persistent or chronic immune thrombocytopenia (ITP), severe aplastic anemia, and those with chronic hepatitis C. It has shown effectiveness by increasing platelet production.
- Thirteen studies were reviewed to gather information about eltrombopag's safety and efficacy compared to other treatments such as romiplostim, avatrombopag, hetrombopag, rituximab, and immunosuppressive therapy alone.
- In treating ITP specifically, eltrombopag demonstrated a significant improvement in platelet response outcomes when compared to placebo or rituximab. This was observed both in adults with refractory ITP as well as children suffering from the condition.
- Regarding ITP treatment scenarios, eltrombopag did not significantly increase the risk of critical adverse events like thrombotic occurrences when compared against controls or other agents like romiplostim or avatrombopag within six months of administration.
- For severe aplastic anemia (SAA) cases, combining eltrombopag with standard immunosuppressive therapy showed higher overall response rates at three and six months than using immunosuppressive therapy alone. However, these benefits seem to plateau after twelve months of treatment regimen.
- The addition of eltrombopag also improved earlier hematologic responses without affecting event-free survival rate nor increased incidence of clonal evolution during SAA treatments, indicating its good safety profile even when combined with immunosuppressive therapies.
- In terms of population types/subgroup considerations, age does not influence treatment effects, suggesting broad applicability across different patient demographics including pediatrics where it protected against severe disease/death indicating a favorable risk-benefit profile. However, caution should be exercised when interpreting its efficacy and safety data, especially for pediatric SAA cases.
- Compared to other Thrombopoietin Receptor Agonists (TPO-RAs) like romiplostim, avatrombopag, and hetrombopag, eltrombopag has shown significant effectiveness in increasing platelet counts with a comparable safety profile regarding serious adverse events.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Promacta (eltrombopag) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |