Drug updated on 11/4/2024
Dosage Form | Injection (subcutaneous; 125 mcg, 250 mcg, 500 mcg) |
Drug Class | Thrombopoietin receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
- Indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Latest News
Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Effectiveness in Persistent Immune Thrombocytopenia (ITP): Romiplostim and eltrombopag achieved higher platelet response rates, with Romiplostim ranking highest in sustaining platelet counts above 50 x 10^9/L. Avatrombopag showed the greatest platelet response (SUCRA (surface under the cumulative ranking curve) = 87.5) followed by rhTPO and eltrombopag.
- Comparative Efficacy in Persistent ITP: Eltrombopag demonstrated superior efficacy relative to rituximab and rhTPO+rituximab, with a risk ratio (RR) of 4.56 and 4.18, respectively. Romiplostim also showed higher RR for platelet response compared to both rituximab and rhTPO+rituximab.
- Efficacy in Chemotherapy-Induced Thrombocytopenia (CIT): TPO-RAs, including romiplostim, significantly reduced the incidence of grade 3 or 4 thrombocytopenia (RR = 0.69), with this reduction remaining statistically significant after Bonferroni correction (P = 0.008).
- The incidence of thrombotic events was slightly higher in patients receiving TPO-RAs, such as romiplostim, with a pooled rate of 2.2% in ITP patients and a thrombotic risk ratio of 1.73, though this was not statistically significant (P = 0.113).
- TPO-RAs, including romiplostim, showed no significant difference in the rates of adverse events (RR = 0.98) or serious adverse events (RR = 0.79) when compared to controls, with similar safety profiles observed across romiplostim, eltrombopag, and avatrombopag.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nplate (romiplostim) Prescribing Information. | 2022 | Amgen Inc., Thousand Oaks, CA |