About
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 their 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 Filgrastim Hexal?
Filgrastim Hexal is a solution for injection or infusion (drip into a vein) in a pre-filled syringe. It contains the active substance filgrastim (30 or 48 million units).
Filgrastim Hexal is a ‘biosimilar’ medicine. This means that Filgrastim Hexal 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 Filgrastim Hexal is Neupogen. For more information on biosimilar medicines, see the question-and-answer document here.
- What is Filgrastim Hexal used for?
Filgrastim Hexal 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 the 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.
Filgrastim Hexal 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 Filgrastim Hexal used?
Filgrastim Hexal 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. Filgrastim Hexal 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 Filgrastim Hexal work?
The active substance in Filgrastim Hexal, 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 Filgrastim Hexal been studied?
Filgrastim Hexal was studied to show that it is comparable to the reference medicine, Neupogen.
Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Filgrastim Hexal or Neupogen. The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein. The main measure in these studies was the neutrophil count over the first 10 days of treatment.
- What benefit has Filgrastim Hexal shown during the studies?
Filgrastim Hexal and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies. This was considered sufficient to demonstrate that the benefits of Filgrastim Hexal are comparable to those of the reference medicine.
- What is the risk associated with Filgrastim Hexal?
The most common side effect with Filgrastim Hexal (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 Filgrastim Hexal is being used for. For the full list of all side effects reported with Filgrastim Hexal, see the Package Leaflet.
Filgrastim Hexal should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
- Why has Filgrastim Hexal been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim Hexal 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 Filgrastim Hexal be given marketing authorisation.
- Other information about Filgrastim Hexal
The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim Hexal to Hexal AG on 06 February 2009.
This EPAR was last updated on 14/09/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
10/08/2011 Filgrastim Hexal -EMEA/H/C/000918 -WS/0136/G
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.
Pharmacotherapeutic group
Immunostimulants
Therapeutic indication
- 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 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. - Mobilisation of peripheral blood progenitor cells (PBPC).
- In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 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.
- Treatment of persistent neutropenia (ANC ≤ 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.
- in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Filgrastim Hexal : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 09/11/2009 | 14/09/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Filgrastim Hexal : EPAR - Public assessment report | (English only) | 16/02/2009 |
Authorised
This medicine is approved for use in the European Union
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