Romiplostim
Also known as: AMG 531, AMG531, Megalace, Nplate, romiplostim
Source Romiplostim at Peptiology
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Summary
Romiplostim is a recombinant fusion protein that mimics thrombopoietin, used to increase platelet counts in immune thrombocytopenia (ITP) and other thrombocytopenic conditions.
Mechanism of Action
Binds and activates the c-Mpl (TPO) receptor on megakaryocyte precursors, stimulating platelet production
Routes of Administration
Goals & Uses
- Chemotherapy-induced thrombocytopenia (investigational)Oncology / Supportive CareLow
- Pediatric ITP managementPediatric HematologyHigh
- Increase platelet count in chronic ITPHematology / ThrombocytopeniaHigh
- Reduce bleeding risk in ITPHematology / HemostasisHigh
- Myelodysplastic syndrome-associated thrombocytopenia (investigational)Hematology / OncologyLow
- Immune thrombocytopenia (ITP)HematologyHigh
Contraindications
- Hematologic malignancies other than ITPOncologicHigh
- Hypersensitivity to romiplostim or any excipientAllergyHigh
- Myelodysplastic syndrome (MDS)OncologicHigh
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
- Hypersensitivity to romiplostim or product componentsImmunologicHigh
Adverse Effects
- Rebound thrombocytopeniaHematologicalCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Thromboembolic eventsCardiovascularUncommon
- Bone marrow reticulin formationHematologicalUncommon
- Arthralgia / myalgiaMusculoskeletalCommon
- Progression to AML / MDS exacerbationOncologicRare
- ThromboembolismCardiovascularUncommon
- Bone‑marrow fibrosisHematologicRare
Drug Interactions
- Other thrombopoietin receptor agonistsHigh
- Immunosuppressants (e.g., corticosteroids, azathioprine)Low
- Antiplatelet agents (e.g., aspirin, clopidogrel)Moderate
- Anticoagulants (e.g., warfarin, heparin)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Hepatic impairmentOrgan FunctionRelative
- Patients with active malignancyOncologyRelative
- Renal impairmentOrgan ImpairmentRelative
- LactationReproductiveRelative
- Children <1 yearPediatricAbsolute
- Pediatric patients <1 yearAgeAbsolute
Regulatory Status
- European UnionApprovedApproved: immune thrombocytopenia (ITP)Same as US
- United StatesApprovedApproved: immune thrombocytopenia (ITP)Approved for adults and children ≥1 year
- United KingdomApprovedApproved: immune thrombocytopenia (ITP)
Black‑box warning for potential bone‑marrow fibrosis and increased risk of thromboembolic events; monitor platelet counts and bone‑marrow status.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Romiplostim?
Romiplostim is a recombinant fusion protein that mimics thrombopoietin, used to increase platelet counts in immune thrombocytopenia (ITP) and other thrombocytopenic conditions.
What is Romiplostim used for?
Romiplostim is educationally associated with: Chemotherapy-induced thrombocytopenia (investigational), Pediatric ITP management, Increase platelet count in chronic ITP, Reduce bleeding risk in ITP, Myelodysplastic syndrome-associated thrombocytopenia (investigational), Immune thrombocytopenia (ITP). Educational only — not medical advice.
How is Romiplostim administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Romiplostim?
Reported adverse effects include: Rebound thrombocytopenia, Headache, Thromboembolic events, Bone marrow reticulin formation, Arthralgia / myalgia, Progression to AML / MDS exacerbation, Thromboembolism, Bone‑marrow fibrosis. This list is not exhaustive — consult a qualified clinician.
Who should avoid Romiplostim?
Recorded contraindications: Hematologic malignancies other than ITP, Hypersensitivity to romiplostim or any excipient, Myelodysplastic syndrome (MDS), Pregnancy, Hypersensitivity to romiplostim or product components. Consult a qualified clinician before use.