Grastofil

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filgrastim

Authorised
This medicine is authorised for use in the European Union.

Overview

Grastofil is a medicine that stimulates the production of white blood cells and is used:

  • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes). Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections;
  • 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 highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU.

This EPAR was last updated on 12/11/2018

Authorisation details

Product details
Name
Grastofil
Agency product number
EMEA/H/C/002150
Active substance
filgrastim
International non-proprietary name (INN) or common name
filgrastim
Therapeutic area (MeSH)
Neutropenia
Anatomical therapeutic chemical (ATC) code
L03AA02
BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Apotex Europe BV
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
17/10/2013
Contact address

Archimedesweg 2
2333 CN Leiden
Netherlands

Product information

04/10/2018 Grastofil - EMEA/H/C/002150 - R/0020

Contents

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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

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