Drug updated on 4/17/2024
| 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.
Summary
- Romiplostim (Nplate) is indicated for the treatment of thrombocytopenia in adult and pediatric patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
- The information about romiplostim was derived from a review of eight systematic reviews/meta-analyses.
- In terms of safety, romiplostim does not significantly increase the risk of thrombotic events compared to other drugs such as eltrombopag, avatrombopag, and hetrombopag, even with different durations (>12 weeks) of treatment.
- Romiplostim has shown significant efficacy in treating pediatric ITP by achieving higher durable and overall platelet responses without increasing risks for significant bleeding or adverse events.
- When compared across ages with other TPO-RAs such as avatrombopag, which showed higher effectiveness among adults, romiplostim demonstrated superior efficacy in terms of platelet response rate, duration of response, along with lower incidence rates for bleeding events while maintaining similar incidences for adverse effects.
- Despite limited comparative clinical data available between TPO-RAs including romiplostim, expert consensus suggests that these drugs are effective at managing adult ITP, indicating a need for more direct comparisons within this drug class.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nplate (romiplostim) Prescribing Information. | 2022 | Amgen Inc., Thousand Oaks, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| American society of hematology 2019 guidelines for immune thrombocytopenia. | 2019 | Blood Advances |