Grastofil

Grastofil can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment. The medicine is available in prefilled syringes and is given by injection under the skin or infusion (drip) into a vein.

The way Grastofil is given, its dose and the duration of treatment depend on why it is being used, the patient’s body weight and the response to treatment. For more information about using Grastofil, see the package leaflet or contact your doctor or pharmacist.

The active substance in Grastofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.

Grastofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy (medicines to treat cancer) known to cause neutropenia. Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Grastofil 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 for 1.4 days which compared with 1.6 days and 1.8 days reported in studies using filgrastim found in the literature. Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.

Studies were also carried out to show that Grastofil produces levels of the active substance in the body that are comparable to the reference medicine, Neupogen.

The most common side effects with Grastofil (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Grastofil is being used for. For the full list of side effects and restrictions with Grastofil, see the package leaflet.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grastofil has been shown to have a comparable quality, safety and effectiveness to Neupogen. Therefore, the Agency’s view was that, as for Neupogen, the benefits of Grastofil are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Grastofil have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Grastofil are continuously monitored. Side effects reported with Grastofil are carefully evaluated and any necessary action taken to protect patients.

Grastofil received a marketing authorisation valid throughout the EU on 18 October 2013.