Nivestim

filgrastim

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This is a summary of the European public assessment report (EPAR) for Nivestim. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nivestim.

What is Nivestim?

Nivestim is a solution for injection or infusion (drip into a vein) that contains the active substance filgrastim. It is available as prefilled syringes (12, 30 or 48 million units).

Nivestim is a ‘biosimilar medicine'. This means that Nivestim is similar to a biological medicine (the ‘reference medicine’) that is already authorised in the European Union (EU) and contains the same active substance as the reference medicine. The reference medicine for Nivestim is Neupogen.

What is Nivestim used for?

Nivestim is used to stimulate the production of white blood cells in the following situations:

  • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (medicines to treat cancer) that is cytotoxic (cell-killing);
  • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
  • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
  • to treat persistent neutropenia in patients with advanced human-immunodeficiency-virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.

Nivestim can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.

The medicine can only be obtained with a prescription.

How is Nivestim used?

Nivestim is given by injection under the skin or infusion into a vein. How it is given, the dose and the duration of treatment depend on why it is being used, the patient’s body weight and the response to treatment. Nivestim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. For more information, see the package leaflet.

How does Nivestim work?

The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G‑CSF). Filgrastim is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim. The replacement acts in the same way as naturally produced G‑CSF by encouraging the bone marrow to produce more white blood cells.

How has Nivestim been studied?

Nivestim was studied to show that it is comparable to the reference medicine, Neupogen. Nivestim was compared with Neupogen in one main study involving 279 women with breast cancer who were being treated with anticancer medicines. The main measure of effectiveness was based on the reduction in the length of time that the patients had severe neutropenia.

What benefit has Nivestim shown during the studies?

Studies carried out with Nivestim showed that it was comparable to Neupogen. In the main study, the patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.

What is the risk associated with Nivestim?

The most common side effect with Nivestim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Nivestim is being used for. For the full list of all side effects reported with Nivestim, see the package leaflet.

Nivestim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.

Why has Nivestim been approved?

The CHMP decided that, in accordance with EU requirements, Nivestim has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, the CHMP’s view was that, as for Neupogen, the benefit outweighs the identified risk. The Committee recommended that Nivestim be given marketing authorisation.

Other information about Nivestim:

The European Commission granted a marketing authorisation valid throughout the EU for Nivestim to Hospira UK Limited on 8 June 2010. The marketing authorisation is valid for five years, after which it can be renewed.

Name Language First published Last updated
Nivestim : EPAR - Summary for the public BG = bălgarski 23/06/2010  
Nivestim : EPAR - Summary for the public ES = español 23/06/2010  
Nivestim : EPAR - Summary for the public CS = čeština 23/06/2010  
Nivestim : EPAR - Summary for the public DA = dansk 23/06/2010  
Nivestim : EPAR - Summary for the public DE = Deutsch 23/06/2010  
Nivestim : EPAR - Summary for the public ET = eesti keel 23/06/2010  
Nivestim : EPAR - Summary for the public EL = elliniká 23/06/2010  
Nivestim : EPAR - Summary for the public EN = English 23/06/2010  
Nivestim : EPAR - Summary for the public FR = français 23/06/2010  
Nivestim : EPAR - Summary for the public IT = italiano 23/06/2010  
Nivestim : EPAR - Summary for the public LV = latviešu valoda 23/06/2010  
Nivestim : EPAR - Summary for the public LT = lietuvių kalba 23/06/2010  
Nivestim : EPAR - Summary for the public HU = magyar 23/06/2010  
Nivestim : EPAR - Summary for the public MT = Malti 23/06/2010  
Nivestim : EPAR - Summary for the public NL = Nederlands 23/06/2010  
Nivestim : EPAR - Summary for the public PL = polski 23/06/2010  
Nivestim : EPAR - Summary for the public PT = português 23/06/2010  
Nivestim : EPAR - Summary for the public RO = română 23/06/2010  
Nivestim : EPAR - Summary for the public SK = slovenčina 23/06/2010  
Nivestim : EPAR - Summary for the public SL = slovenščina 23/06/2010  
Nivestim : EPAR - Summary for the public FI = suomi 23/06/2010  
Nivestim : EPAR - Summary for the public SV = svenska 23/06/2010  

This EPAR was last updated on 07/02/2014 .

Authorisation details

Product details

Product details for Nivestim
NameNivestim
Agency product numberEMEA/H/C/001142
Active substance

filgrastim

International non-proprietary name (INN) or common name

filgrastim

Therapeutic area NeutropeniaHematopoietic Stem Cell TransplantationCancer
Anatomical therapeutic chemical (ATC) code L03AA02
Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Nivestim
Marketing-authorisation holder

Hospira UK Ltd.
 

Revision6
Date of issue of marketing authorisation valid throughout the European Union08/06/2010

Contact address:

Hospira UK Ltd.
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom

Product information

Product information

21/01/2014  Nivestim -EMEA/H/C/001142 -IB/0019

Name Language First published Last updated
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014
Nivestim : EPAR - Product Information SV = svenska 23/06/2010 07/02/2014

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
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  
Nivestim : EPAR - All Authorised presentations SV = svenska 23/06/2010  

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.

The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.

Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).

In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Filgrastim is indicated for the treatment of persistent neutropenia (ANC  ≤1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nivestim : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 13/09/2010 07/02/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Nivestim : EPAR - Public assessment report SV = svenska 23/06/2010  
CHMP positive summary of opinion for Nivestim SV = svenska 19/03/2010  

Authorised

This medicine is approved for use in the European Union

More information on Nivestim