Nplate

romiplostim

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Nplate?

Nplate is a powder that is made up into a solution for injection. Nplate is available with or without a solvent. It contains the active substance romiplostim.

What is Nplate used for?

Nplate is used in adults with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient’s immune system destroys the platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts and are at risk of bleeding.

Nplate is used in patients who have already been treated with medicines such as corticosteroids or immunoglobulins and who have had their spleen removed, if these treatments have not worked. It can also be considered for use in patients who have been treated for ITP who have a spleen and cannot have surgery. The spleen is an organ that is involved in the destruction of platelets.

Because the number of patients with ITP is low, the disease is considered ‘rare’, and Nplate was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 May 2005.

The medicine can only be obtained with a prescription.

How is Nplate used?

Treatment with Nplate should be supervised by a doctor who has experience in treating blood diseases.

Nplate is given once a week as an injection under the skin. The starting dose depends on the patient’s weight, and is then adjusted every week to maintain platelet counts at target levels. Treatment can be interrupted if platelet counts become too high. Treatment with Nplate should be stopped after four weeks of treatment with the maximum dose of Nplate if the platelet count does not reach levels that are high enough to reduce the risk of bleeding. Some patients whose platelet levels have stabilised may be able to administer the medicine themselves after they have been properly trained.

How does Nplate work?

The active substance in Nplate, romiplostim, is a medicine that stimulates the production of platelets. In the body, a hormone called ‘thrombopoietin’ stimulates the production of platelets in the bone marrow. Romiplostim is a protein that has been ‘engineered’ (specifically designed) so that it can attach to and stimulate the same receptors as thrombopoietin. By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, increasing blood platelet counts.

Romiplostim is produced by a method known as ‘recombinant DNA technology’: it is made by bacteria into which a gene (DNA) has been introduced which makes them able to produce romiplostim.

How has Nplate been studied?

Nplate has been compared with placebo (a dummy treatment) in two main studies involving adults with long-term ITP. The first study involved 63 patients whose spleens had been removed but whose disease was still not controlled. The second study involved 62 patients who still had their spleens and who had been treated for ITP in the past.

In both studies, the main measure of effectiveness was the number of patients who had a lasting response to treatment. This was classified as the patient’s platelet counts being above 50 million per millilitre for at least six of the last eight weeks of the 24-week treatment period, without the need for any other medicines for ITP. Platelet counts below 30 million per millilitre are considered to put ITP patients at risk of bleeding, while normal counts are between 150 and 400 million per millilitre.

What benefit has Nplate shown during the studies?

Nplate was more effective than placebo at increasing blood platelet counts. In the study of patients whose spleen had been removed, 38% of the patients had a lasting response to treatment with Nplate (16 out of 42), compared with none of the 21 patients receiving placebo. In the study of patients with a spleen, 61% of the patients had a lasting response to treatment with Nplate (25 out of 41), compared with 5% of the patients receiving placebo (1 out of 21).

What is the risk associated with Nplate?

The most common side effects with Nplate (seen in more than 1 patient in 10) are headache and hypersensitivity (allergic reactions). For the full list of all side effects reported with Nplate, see the package leaflet.

Nplate must not be used in people who are hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).

Why has Nplate been approved?

The CHMP noted that the effectiveness of Nplate had been shown in patients whose spleens had been removed, as well as in patients who still had their spleens. However, because removal of the spleen is a potential cure for ITP, the Committee concluded that Nplate should only be used in patients with a spleen if they are not able to undergo surgery. The CHMP decided that Nplate’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What information is still awaited for Nplate?

The company that makes Nplate will provide educational packs for doctors in each Member State. The packs will include information on the safety and effectiveness of Nplate. They will also remind doctors how to use the medicine and to discuss the benefits and risks of Nplate with patients. Doctors will also receive a ‘dosing calculator’ to help them calculate the volumes of Nplate that need to be injected. These volumes can sometimes be very small.

Other information about Nplate

The European Commission granted a marketing authorisation valid throughout the European Union for Nplate on 4 February 2009.

For more information about treatment with Nplate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Nplate : EPAR - Summary for the public BG = bălgarski 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public ES = español 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public CS = čeština 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public DA = dansk 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public DE = Deutsch 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public ET = eesti keel 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public EL = elliniká 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public EN = English 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public FR = français 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public IT = italiano 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public LV = latviešu valoda 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public LT = lietuvių kalba 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public HU = magyar 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public MT = Malti 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public NL = Nederlands 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public PL = polski 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public PT = português 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public RO = română 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public SK = slovenčina 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public SL = slovenščina 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public FI = suomi 12/02/2009 22/01/2014
Nplate : EPAR - Summary for the public SV = svenska 12/02/2009 22/01/2014

This EPAR was last updated on 31/07/2014 .

Authorisation details

Product details

Product details for Nplate
NameNplate
Agency product numberEMEA/H/C/000942
Active substance

romiplostim

International non-proprietary name (INN) or common name

romiplostim

Therapeutic area Purpura, Thrombocytopenic, Idiopathic
Anatomical therapeutic chemical (ATC) code B02BX04
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Nplate
Marketing-authorisation holder

Amgen Europe B.V.

Revision9
Date of issue of marketing authorisation valid throughout the European Union04/02/2009

Contact address:

Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

Product information

26/05/2014  Nplate -EMEA/H/C/000942 -N/0043

Name Language First published Last updated
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014
Nplate : EPAR - Product Information SV = svenska 12/03/2009 31/07/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012
Nplate : EPAR - All Authorised presentations SV = svenska 12/03/2009 12/11/2012

Name Language First published Last updated
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011
Nplate : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 12/02/2009 04/02/2011

Pharmacotherapeutic group

Antihaemorrhagics

Therapeutic indication

Nplate is indicated for adult chronic-immune (idiopathic)-thrombocytopenic-purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Nplate may be considered as second-line treatment for adult non-splenectomised patients where surgery is contra-indicated.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nplate : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 12/03/2009 31/07/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Nplate : EPAR - Public assessment report SV = svenska 12/02/2009  
Committee for medicinal products for human use, summary of positive opinion for Nplate SV = svenska 20/11/2008  

Authorised

This medicine is approved for use in the European Union