DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Nplate (Romiplostim Subcutaneous) - Summary

 
 



NPLATE SUMMARY

Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli (E coli).Nplate is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection.

Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.


See all Nplate indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Nplate (Romiplostim Subcutaneous)

A randomized, double-blind study of romiplostim to determine its safety and efficacy in children with immune thrombocytopenia. [2011.07.07]
Romiplostim, a thrombopoietin-mimetic peptibody, increases and maintains platelet counts in adults with immune thrombocytopenia (ITP). In this first study of a thrombopoietic agent in children, patients with ITP of >/= 6 months' duration were stratified by age 1:2:2 (12 months-< 3 years; 3-< 12 years; 12-< 18 years)...

Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: a double-blind, randomized Phase III clinical trial. [2011.07]
The efficacy and safety of romiplostim, a thrombopoietin-mimetic peptibody, were evaluated in a double-blind, placebo-controlled, randomized trial of Japanese patients with chronic immune thrombocytopenia (ITP). Thirty-four ITP patients received romiplostim (n = 22) or placebo (n = 12) for 12 weeks, with a starting romiplostim dose of 3 mug/kg weekly.

Subcutaneous or intravenous administration of romiplostim in thrombocytopenic patients with lower risk myelodysplastic syndromes. [2011.03.01]
BACKGROUND: Romiplostim is a peptibody protein that augments thrombopoiesis by activating the thrombopoietin receptor... CONCLUSIONS: The safety and efficacy profiles of romiplostim in this study suggested that weekly subcutaneous administration of 750 mug romiplostim is an appropriate starting dose for future clinical studies in patients with MDS and thrombocytopenia. Copyright (c) 2010 American Cancer Society.

Analysis of EQ-5D scores from two phase 3 clinical trials of romiplostim in the treatment of immune thrombocytopenia (ITP). [2011]
including platelet response status and bleeding events... CONCLUSIONS: Using romiplostim in cases of chronic ITP was associated with

Romiplostim or standard of care in patients with immune thrombocytopenia. [2010.11.11]
BACKGROUND: Romiplostim, a thrombopoietin mimetic, increases platelet counts in patients with immune thrombocytopenia, with few adverse effects... CONCLUSIONS: Patients treated with romiplostim had a higher rate of a platelet response, lower incidence of treatment failure and splenectomy, less bleeding and fewer blood transfusions, and a higher quality of life than patients treated with the standard of care. ( ClinicalTrials.gov number, NCT00415532.).

more studies >>

Clinical Trials Related to Nplate (Romiplostim Subcutaneous)

AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin [Recruiting]
The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim).

Primary Objectives:

1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy

2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia

3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy

Secondary Objective:

1. To evaluate limited pharmacokinetics of AMG 531 administered by S. C. route post-chemotherapy

Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy [Recruiting]
This phase II trial studies how well romiplostim works in increasing low platelet counts in patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make platelets after chemotherapy

Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia [Recruiting]
RATIONALE: Romiplostim may cause the body to make platelets.

PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating hepatitis C-infected patients with thrombocytopenia.

A Prospective, Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP) [Recruiting]
This is a prospective, phase IV, multi-center, open label, study evaluating the changes in bone marrow reticulin and collagen in adult subjects receiving romiplostim for the treatment of thrombocytopenia associated with ITP.

The purpose of this study is to evaluate changes in bone marrow morphology (structure) after long-term exposure to romiplostim.

Subjects, diagnosed with ITP according to the ASH Guidelines, will be sequentially enrolled into the following groups:

- Bone marrow biopsy at baseline and Year 1

- Bone marrow biopsy at baseline and Year 2

- Bone marrow biopsy at baseline and Year 3

All subjects will receive romiplostim for 3 years, unless withdrawn from the study early. All subjects will return for 1 visit post treatment for End of Study (EOS) procedures.

Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) [Recruiting]
This is a Phase 2, multicenter, randomized, double blind, placebo controlled study designed to assess the efficacy and safety of romiplostim (formerly, AMG 531) treatment in thrombocytopenic MDS subjects. The study is composed of a 26-week placebo controlled test treatment period (romiplostim versus Placebo), a 4 week interim wash-out period, a 24-week placebo controlled extended treatment period, and a 4-week follow-up period followed by an End of Study (EOS) visit. During the interim wash-out period, a bone marrow biopsy will be performed in the absence of growth factor to assess changes in the marrow. In the extended treatment period, safety assessments will continue and subjects will be allowed to receive any standard of care treatments for MDS. Subjects will be followed for survival for an additional 60 months following the End of Study (EOS) visit.

more trials >>

Reports of Suspected Nplate (Romiplostim Subcutaneous) Side Effects

Therapeutic Response Decreased (281)Platelet Count Decreased (260)Drug Ineffective (247)Thrombocytopenia (168)Death (155)Haemorrhage (105)Hospitalisation (92)Haemoglobin Decreased (84)Rectal Haemorrhage (78)Vaginal Haemorrhage (78)more >>


Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012