Grastofil

filgrastim

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This is a summary of the European public assessment report (EPAR) for Grastofil. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Grastofil.

For practical information about using Grastofil, patients should read the package leaflet or contact their doctor or pharmacist.

What is Grastofil and what is it used for?

Grastofil is a medicine that contains the active substance filgrastim. Grastofil 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 help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;
  • 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.

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

How is Grastofil used?

Grastofil is available in pre-filled syringes as a solution for injection or infusion (drip). It is given by injection under the skin or infusion into a vein. It can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.

The way Grastofil is given, its dose and the duration of treatment depend on why it is being used, the patient’s body weight and the response to treatment. More information can be found in the summary of product characteristics (also part of the EPAR).

How does Grastofil work?

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

What benefits of Grastofil have been shown in studies?

Grastofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy (medicines to treat cancer) known to cause neutropenia. Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Grastofil the next day and daily for up to 14 days. The main measure of effectiveness was the duration of severe neutropenia. Severe neutropenia lasted on average for 1.4 days which compared with 1.6 days and 1.8 days reported in studies using filgrastim found in the literature. Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.

Studies were also carried out to show that Grastofil produces levels of the active substance in the body that are comparable to the reference medicine, Neupogen.

What are the risks associated with Grastofil?

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

Why is Grastofil approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Grastofil 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 risks. The Committee recommended that Grastofil be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Grastofil?

A risk management plan has been developed to ensure that Grastofil is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Grastofil, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Grastofil will carry out studies to confirm the long-term safety of Grastofil.

Other information about Grastofil

The European Commission granted a marketing authorisation valid throughout the European Union for Grastofil on 18 October 2013.

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

Name Language First published Last updated
Grastofil : EPAR - Summary for the public BG = bălgarski 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public ES = español 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public CS = čeština 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public DA = dansk 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public DE = Deutsch 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public ET = eesti keel 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public EL = elliniká 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public EN = English 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public FR = français 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public IT = italiano 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public LV = latviešu valoda 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public LT = lietuvių kalba 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public HU = magyar 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public MT = Malti 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public NL = Nederlands 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public PL = polski 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public PT = português 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public RO = română 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public SK = slovenčina 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public SL = slovenščina 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public FI = suomi 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public SV = svenska 2013-11-11 2014-06-16
Grastofil : EPAR - Summary for the public HR = Hrvatski 2013-11-11 2014-06-16

This EPAR was last updated on 02/09/2016 .

Authorisation details

Product details

Product details for Grastofil
NameGrastofil
Agency product numberEMEA/H/C/002150
Active substance

filgrastim

International non-proprietary name (INN) or common name

filgrastim

Therapeutic area Neutropenia
Anatomical therapeutic chemical (ATC) code L03AA02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

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 Grastofil
Marketing-authorisation holder

Apotex Europe BV

Revision7
Date of issue of marketing authorisation valid throughout the European Union18/10/2013

Contact address:

Apotex Europe BV
Darwinweg 20
2333 CR Leiden 
The Netherlands

Product information

Product information

01/08/2016  Grastofil -EMEA/H/C/002150 -IB/0012/G

Name Language First published Last updated
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02
Grastofil : EPAR - Product Information HR = Hrvatski 2013-11-11 2016-09-02

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
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  
Grastofil : EPAR - All Authorised presentations HR = Hrvatski 2013-11-11  

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Grastofil 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 Grastofil are similar in adults and children receiving cytotoxic chemotherapy.

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

Grastofil 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
Grastofil : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-01-03 2016-09-02

Initial marketing-authorisation documents

Name Language First published Last updated
Grastofil : EPAR - Public assessment report HR = Hrvatski 2013-11-11  
CHMP summary of positive opinion for Grastofil HR = Hrvatski 2013-07-26  

Authorised

This medicine is approved for use in the European Union

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