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Hematology · FDA Approved

Romiplostim (Nplate)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A thrombopoietin (TPO) receptor agonist built as a peptibody: TPO-mimetic peptides fused to the Fc portion of human IgG1. It has a similar mechanism of action to TPO but no sequence homology with it (PMID 21476045).

Romiplostim stimulates megakaryocyte growth and platelet production. In its pivotal trials no antibodies against romiplostim or endogenous TPO were detected (PMID 18242413).

02 · Research summary & key findings

FDA-approved in 2008 (Nplate) for adults with chronic immune thrombocytopenia (ITP) with an insufficient response to other treatments. In two 24-week randomized trials, overall platelet responses occurred in 88% of non-splenectomized and 79% of splenectomized patients on romiplostim vs. 14% and 0% on placebo; durable responses were less common (16 of 42 splenectomized and 25 of 41 non-splenectomized patients) (PMID 18242413). A long-term open-label study showed maintained platelet responses for up to 5 years of weekly treatment (PMID 23432528). In a bone marrow study, about 7% of patients had increases in reticulin or collagen, which were reversible in those re-biopsied after stopping (PMID 27130310).

03 · Regulatory status

Romiplostim (Nplate) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Romiplostim (Nplate) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Subcutaneous injection (weekly)

References

  1. [1]Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial Lancet, 2008. PMID 18242413
  2. [2]Investigation of the pharmacokinetics of romiplostim in rodents with a focus on the clearance mechanism Pharm Res, 2011. PMID 21476045
  3. [3]Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy Br J Haematol, 2013. PMID 23432528
  4. [4]Changes in bone marrow morphology in adults receiving romiplostim for the treatment of thrombocytopenia associated with primary immune thrombocytopenia Ann Hematol, 2016. PMID 27130310

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.