Tevagrastim

filgrastim

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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 Tevagrastim?

Tevagrastim is a solution for injection or for infusion (drip into a vein). It contains the active substance filgrastim.

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

What is Tevagrastim used for?

Tevagrastim 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 (cancer treatment) that is cytotoxic (cell-killing);
  • to reduce the duration of neutropenia in patients undergoing treatment to destroy bone-marrow cells before a bone-marrow transplant (such as in some patients with leukaemia) if they are at a 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.

Tevagrastim can also be used in patients 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 Tevagrastim used?

Tevagrastim 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. Tevagrastim 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 Tevagrastim work?

The active substance in Tevagrastim, 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 same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.

How has Tevagrastim been studied?

Tevagrastim was studied to show that it is comparable to the reference medicine, Neupogen.

Tevagrastim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer. The study looked at the duration of severe neutropenia during the patients’ first cycle of cytotoxic chemotherapy.

To study the safety of Tevagrastim, two further studies were carried out in patients with lung cancer and with non-Hodgkin’s lymphoma.

What benefit has Tevagrastim shown during the studies?

Treatment with Tevagrastim and Neupogen brought about similar reductions in duration of severe neutropenia. During the first 21-day chemotherapy cycle, patients treated with either Tevagrastim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo. Therefore, the effectiveness of Tevagrastim was shown to be equivalent to that of Neupogen.

What is the risk associated with Tevagrastim?

The most common side effect with Tevagrastim (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 Tevagrastim is being used for. For the full list of all side effects reported with Tevagrastim, see the package leaflet.

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

Why has Tevagrastim been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Tevagrastim 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 Tevagrastim be given marketing authorisation.

Other information about Tevagrastim

The European Commission granted a marketing authorisation valid throughout the EU for Tevagrastim to Teva Generics GmbH on 15 September 2008.

Name Language First published Last updated
Tevagrastim : EPAR - Summary for the public BG = bălgarski 29/09/2008  
Tevagrastim : EPAR - Summary for the public ES = español 29/09/2008  
Tevagrastim : EPAR - Summary for the public CS = čeština 29/09/2008  
Tevagrastim : EPAR - Summary for the public DA = dansk 29/09/2008  
Tevagrastim : EPAR - Summary for the public DE = Deutsch 29/09/2008  
Tevagrastim : EPAR - Summary for the public ET = eesti keel 29/09/2008  
Tevagrastim : EPAR - Summary for the public EL = elliniká 29/09/2008  
Tevagrastim : EPAR - Summary for the public EN = English 29/09/2008  
Tevagrastim : EPAR - Summary for the public FR = français 29/09/2008  
Tevagrastim : EPAR - Summary for the public IT = italiano 29/09/2008  
Tevagrastim : EPAR - Summary for the public LV = latviešu valoda 29/09/2008  
Tevagrastim : EPAR - Summary for the public LT = lietuvių kalba 29/09/2008  
Tevagrastim : EPAR - Summary for the public HU = magyar 29/09/2008  
Tevagrastim : EPAR - Summary for the public MT = Malti 29/09/2008  
Tevagrastim : EPAR - Summary for the public NL = Nederlands 29/09/2008  
Tevagrastim : EPAR - Summary for the public PL = polski 29/09/2008  
Tevagrastim : EPAR - Summary for the public PT = português 29/09/2008  
Tevagrastim : EPAR - Summary for the public RO = română 29/09/2008  
Tevagrastim : EPAR - Summary for the public SK = slovenčina 29/09/2008  
Tevagrastim : EPAR - Summary for the public SL = slovenščina 29/09/2008  
Tevagrastim : EPAR - Summary for the public FI = suomi 29/09/2008  
Tevagrastim : EPAR - Summary for the public SV = svenska 29/09/2008  

This EPAR was last updated on 03/01/2014 .

Authorisation details

Product details

Product details for Tevagrastim
NameTevagrastim
Agency product numberEMEA/H/C/000827
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 Tevagrastim
Marketing-authorisation holder

Teva GmbH

Revision8
Date of issue of marketing authorisation valid throughout the European Union15/09/2008

Contact address:

Teva GmbH
Wasastraße 50
DE-01445 Radebeul
Germany

Product information

Product information

30/10/2013  Tevagrastim -EMEA/H/C/000827 -IB/0039

Name Language First published Last updated
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014
Tevagrastim : EPAR - Product Information SV = svenska 19/10/2009 03/01/2014

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
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  
Tevagrastim : EPAR - All Authorised presentations SV = svenska 19/10/2009  

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Tevagrastim 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.

Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).

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 Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 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
Tevagrastim : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 19/10/2009 03/01/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Tevagrastim : EPAR - Public assessment report SV = svenska 29/09/2008  
Committee for medicinal products for human use, summary of positive opinion for Tevagrastim SV = svenska 25/07/2008  

Authorised

This medicine is approved for use in the European Union

More information on Tevagrastim