What is Nivestim?
Nivestim is a solution for injection or infusion (drip into a vein) containing the active substance filgrastim. It is available in pre-filled syringes (with 12, 30 or 48 million units).
Nivestim is a "biosimilar" medicine. This means that Nivestim is similar to a biological medicine, the 'reference medicine', already authorized in the European Union (EU) and contains the same active substance as the reference medicine. The reference medicine for Nivestim is Neupogen.
What is Nivestim used for?
Nivestim 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 (anticancer treatment) 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 prolonged 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.
Nivestim can also be used used in subjects who are about to donate blood stem cells for a transplant, in order to promote the release of these cells from the bone marrow.
The medicine can only be obtained with a prescription.
How is Nivestim used?
Nivestim is given by subcutaneous injection or intravenous infusion. The method of administration, dosage and duration of treatment depend on the reason for its use, the patient's body weight and the response to treatment. Nivestim is generally given in a specialized treatment center, although patients who are injected under the skin can inject it themselves once they have been properly trained. For more information, see the package leaflet.
How does Nivestim work?
The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim is obtained by a method known as "recombinant DNA technology": it is produced by a bacterium in which a gene (DNA) has been grafted which makes it able to generate filgrastim. The substitute acts in a similar way to natural G-CSF, stimulating the bone marrow to produce more white blood cells.
How has Nivestim been studied?
Nivestim was studied to demonstrate its comparability with the reference medicine, Neupogen. Nivestim was compared with Neupogen in one main study involving 279 women with breast cancer who were treated with anticancer medicines. The main measure of effectiveness was based on reducing the duration of severe neutropenia in patients.
What benefit has Nivestim shown during the studies?
Studies carried out on Nivestim showed that it was comparable to Neupogen. In the main study, the duration of severe neutropenia in patients treated with Nivestim was similar to that recorded in patients treated with Neupogen.
What are the risks associated with Nivestim?
The most common side effect with Nivestim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects can be seen in more than 1 in 10 patients, depending on the condition for which Nivestim is used. For the full list of all side effects reported with Nivestim, see the Package Leaflet.
Nivestim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Why has Nivestim been approved?
The CHMP decided that, based on the provisions of EU legislation, it was shown that Nivestim possesses characteristics of quality, safety and efficacy similar to those of Neupogen. The CHMP was therefore of the opinion that, as in the case of Neupogen, the benefits outweighed the identified risks. The committee recommended the granting of a marketing authorization for Nivestim.
More information on Nivestim
On 8 June 2010, the European Commission granted a marketing authorization valid for Nivestim, valid throughout the European Union, to Hospira UK Limited. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Nivestim can be found here. For more information about treatment with Nivestim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 06-2010
