What is Accofil - filgrastim and what is it used for?
Accofil is a medicine 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 (a therapy used to treat tumors) cytotoxic (able to cause the cell death);
- to reduce the duration of neutropenia in patients undergoing treatment aimed at destroying bone marrow cells before a bone marrow transplant (for example, in some patients with leukemia), if they are at risk of long-term severe neutropenia;
- to contribute to the release of cells from the spinal cord in patients selected as haematopoietic stem cell donors for transplantation;
- 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.
Accofil, which contains the active substance filgrastim, is a "biosimilar medicine". This means that it should have been similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Accofil is Neupogen. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Accofil - filgrastim used?
Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes. Accofil is given by subcutaneous injection or intravenous infusion. The medicine can only be obtained with a prescription and the therapy must be carried out in collaboration with an oncology center. The method of administration of Accofil, the dosage and duration of treatment depend on the reason for its use, the patient's body weight and the response to treatment. For more information, see the summary of product characteristics (also part of the EPAR).
How does Accofil - filgrastim work?
The active substance in Accofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim acts similarly to the naturally produced G-CSF factor, stimulating the bone marrow to produce more white blood cells. The active ingredient present in Accofil is produced with a method known as "recombinant DNA technology": that is, it is obtained from bacteria in which a gene (DNA) has been introduced that allows them to produce filgrastim.
What benefit has Accofil - filgrastim shown during the studies?
Studies have also been conducted to show that Accofil produces similar levels of the active ingredient in the body as those obtained with Neupogen and increases the number of neutrophils in a similar manner. Accofil was examined in one main study involving 120 women with breast cancer treated with chemotherapy known to cause neutropenia. Patients underwent chemotherapy on day 1 of a three-week cycle and were treated with a 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 1.4 days compared to the duration of 1.6 days and 1.8 days reported in other studies available in the literature on filgrastim. Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
What is the risk associated with Accofil - filgrastim?
The most common side effect with Accofil (which may affect 1 in 10 patients) is musculoskeletal pain (pain in muscles and bones). Other side effects may affect more than 1 in 10 patients, depending on the condition treated with Accofil. For the full list of all side effects and restrictions with Accofil, see the package leaflet.
Why has Accofil - filgrastim been 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 considered that, as in the case of Neupogen, the benefit outweighs the identified risks and recommended the granting of the marketing authorization for Accofil.
What measures are being taken to ensure the safe and effective use of Accofil - filgrastim?
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 is available in the summary of the risk management plan.
More information on Accofil - filgrastim
On 18 September 2014, the European Commission issued a marketing authorization for Accofil, valid throughout the European Union. For more information about treatment with Accofil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2014.
