Accofil

filgrastim

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This is a summary of the European public assessment report (EPAR) for Accofil. 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 Accofil.

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

What is Accofil and what is it used for?

Accofil is a medicine that 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 cytotoxic chemotherapy (medicines to treat cancer by killing cells);
  • 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.

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

How is Accofil used?

Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes. 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 Accofil 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 Accofil work?

The active substance in Accofil, 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 Accofil 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 Accofil have been shown in studies?

Studies were carried out to show that Accofil produces similar levels of the active substance in the body to Neupogen and increases the numbers of neutrophils in a comparable way.

Accofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy known to cause neutropenia. Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Accofil 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. This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim. Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.

What are the risks associated with Accofil?

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

Why is Accofil approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil 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 and recommended that it be approved for use in the EU.

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

A risk management plan has been developed to ensure that Accofil 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 Accofil, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Accofil

The European Commission granted a marketing authorisation valid throughout the European Union for Accofil on 18 September 2014.

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

Name Language First published Last updated
Accofil : EPAR - Summary for the public BG = bălgarski 28/10/2014  
Accofil : EPAR - Summary for the public ES = español 28/10/2014  
Accofil : EPAR - Summary for the public CS = čeština 28/10/2014  
Accofil : EPAR - Summary for the public DA = dansk 28/10/2014  
Accofil : EPAR - Summary for the public DE = Deutsch 28/10/2014  
Accofil : EPAR - Summary for the public ET = eesti keel 28/10/2014  
Accofil : EPAR - Summary for the public EL = elliniká 28/10/2014  
Accofil : EPAR - Summary for the public EN = English 28/10/2014  
Accofil : EPAR - Summary for the public FR = français 28/10/2014  
Accofil : EPAR - Summary for the public IT = italiano 28/10/2014  
Accofil : EPAR - Summary for the public LV = latviešu valoda 28/10/2014  
Accofil : EPAR - Summary for the public LT = lietuvių kalba 28/10/2014  
Accofil : EPAR - Summary for the public HU = magyar 28/10/2014  
Accofil : EPAR - Summary for the public MT = Malti 28/10/2014  
Accofil : EPAR - Summary for the public NL = Nederlands 28/10/2014  
Accofil : EPAR - Summary for the public PL = polski 28/10/2014  
Accofil : EPAR - Summary for the public PT = português 28/10/2014  
Accofil : EPAR - Summary for the public RO = română 28/10/2014  
Accofil : EPAR - Summary for the public SK = slovenčina 28/10/2014  
Accofil : EPAR - Summary for the public SL = slovenščina 28/10/2014  
Accofil : EPAR - Summary for the public FI = suomi 28/10/2014  
Accofil : EPAR - Summary for the public SV = svenska 28/10/2014  
Accofil : EPAR - Summary for the public HR = Hrvatski 28/10/2014  
Name Language First published Last updated
Accofil : EPAR - Risk-management-plan summary (English only) 28/10/2014  

This EPAR was last updated on 19/02/2016 .

Authorisation details

Product details

Product details for Accofil
NameAccofil
Agency product numberEMEA/H/C/003956
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 Accofil
Marketing-authorisation holder

Accord Healthcare Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union18/09/2014

Contact address:

Accord Healthcare Ltd
Sage House 
319 Pinner Road 
North Harrow 
HA1 4HF 
United Kingdom

Product information

Product information

13/01/2016  Accofil -EMEA/H/C/003956 -IAIN/0007/G

Name Language First published Last updated
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016
Accofil : EPAR - Product Information EN = English 28/10/2014 19/02/2016

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
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016
Accofil : EPAR - All Authorised presentations EN = English 28/10/2014 19/02/2016

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

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

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

Accofil 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
Accofil : EPAR - Procedural steps taken and scientific information after authorisation EN = English 12/03/2015 19/02/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Accofil : EPAR - Public assessment report EN = English 28/10/2014  
CHMP summary of positive opinion for Accofil EN = English 25/07/2014  

Authorised

This medicine is approved for use in the European Union