PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Filgrastim ratiopharm?
Filgrastim ratiopharm is a solution for injection or infusion (drip into a vein). Contains the
active ingredient filgrastim.
Filgrastim ratiopharm is a "biosimilar" medicine, meaning that it is similar to a biological medicine already authorized in the European Union (EU) that contains the same active substance (also called "reference medicine"). The reference medicine for Filgrastim ratiopharm is Neupogen. For more information on biosimilar medicines, see the questions and answers by clicking here.
What is Filgrastim ratiopharm used for?
Filgrastim ratiopharm 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 incidence of febrile neutropenia (neutropenia with fever) in patients undergoing chemotherapy (treatment of a tumor) cytotoxic (cell destroyer);
• to reduce the duration of neutropenia in patients undergoing treatment aimed at destroying bone marrow cells before a transplant of the same (as in some leukemic patients) if they are at risk of long-term severe neutropenia;
• to increase neutrophil levels and reduce the risk of infection in patients with neutropenia who have a history of serious and repeated infections;
• to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, in order to reduce the risk of bacterial infections when other treatments are inadequate.
Filgrastim ratiopharm can also be used in patients who are about to donate stem cells for a transplant, to help them release these cells from the bone marrow.
The medicine can only be obtained with a prescription.
How is Filgrastim ratiopharm used?
Filgrastim ratiopharm is given by subcutaneous injection or intravenous infusion. How it is administered, the dosage and duration of treatment depend on the reason for its use, the patient's body weight and the response to treatment. Filgrastim ratiopharm is generally given in a specialized treatment center, although patients who are injected under the skin can inject it themselves, provided they are properly trained. For more information, see the package leaflet.
How does Filgrastim ratiopharm work?
The active ingredient in Filgrastim ratiopharm, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim is produced with a
method known as "recombinant DNA technology": it derives from a bacterium, in which a gene (DNA) has been grafted which makes it capable of producing filgrastim. The substitute acts similarly to the naturally produced G-CSF factor, stimulating the bone marrow to produce more white blood cells.
What studies have been performed on Filgrastim ratiopharm?
Filgrastim ratiopharm has been studied to demonstrate its similarity to the reference preparation, Neupogen.
A main study compared Filgrastim ratiopharm to Neupogen and a placebo (a dummy treatment) with the participation of 348 breast cancer patients. The study examined the duration of severe neutropenia during the first cycle of cytotoxic chemotherapy in patients. Two other studies were carried out on patients with lung cancer and non-Hodgkin's lymphoma to examine the safety of Filgrastim ratiopharm.
What benefit has Filgrastim ratiopharm shown during the studies?
Treatment with Filgrastim ratiopharm and Neupogen gave almost similar reductions in the duration of severe neutropenia. In the first 21 days of the chemotherapy cycle, patients treated with both Filgrastim ratiopharm and Neupogen had on average 1.1 days of severe neutropenia, compared with 3.8 days of those treated with placebo. Therefore, the efficacy of Filgrastim ratiopharm proved to be equivalent to that of Neupogen.
What is the risk associated with Filgrastim ratiopharm?
The most common side effect seen with Filgrastim ratiopharm (in more than 1 patient in 10)
are musculoskeletal pains (pain in the muscles and bones). In more than one in 10 patients other side effects may be observed, depending on the disease for which Filgrastim ratiopharm is used. For the full list of all side effects reported with Filgrastim ratiopharm, see the Package Leaflet.
Filgrastim ratiopharm should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Why has Filgrastim ratiopharm been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that, according to the provisions of the European Union regulations, Filgrastim ratiopharm demonstrated quality, safety and efficacy characteristics similar to those of Neupogen. The CHMP is therefore of the opinion that, as in the case of Neupogen, the benefits outweigh the identified risks. The Committee recommended that Filgrastim ratiopharm be granted marketing authorization.
More information on Filgrastim ratiopharm
On 15 September 2008, the European Commission granted a marketing authorization for Filgrastim ratiopharm, valid throughout the European Union, to Ratiopharm GmbH.
The full EPAR for Filgrastim ratiopharm can be found here.
Last update of this summary: 09-2008.
