Basic Information
L03AA02
filgrastim
Immunostimulants
Therapeutic indication
Ratiograstim is indicated for the 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 for the 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.
Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ? 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Ratiograstim is indicated for the treatment of persistent neutropenia (ANC ? 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Overview Summary
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 its 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).
Active Substances (2)
filgrastim
filgrastim
Documents (9)
CVMP summary of positive opinion for Ratiogratim
July 24, 2008
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Ratiograstim : EPAR - Risk-management-plan summary
October 19, 2020
RISK_MANAGEMENT_PLAN_SUMMARY
Ratiograstim : EPAR - Product Information
November 25, 2009
DRUG_PRODUCT_INFORMATION
Ratiograstim : EPAR - All Authorised presentations
November 25, 2009
AUTHORISED_PRESENTATIONS
Ratiograstim : EPAR - Public assessment report
September 28, 2008
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Ratiograstim : EPAR - Procedural steps taken and scientific information after authorisation
November 25, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Ratiograstim : EPAR - Summary for the public
September 28, 2009
OVERVIEW_DOCUMENT
Ratiograstim : EPAR - Public assessment report
September 28, 2008
CHANGES_SINCE_INITIAL_AUTHORISATION
CVMP summary of positive opinion for Ratiogratim
July 24, 2008
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (9)
Question
How does Ratiograstim work?
Answer
The active substance in Ratiograstim, 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 same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Question
How is Ratiograstim used?
Answer
Ratiograstim 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. Ratiograstim 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.
Question
Other information about Ratiograstim
Answer
The European Commission granted a marketing authorisation valid throughout the EU for Ratiograstim to ratiopharm GmbH on 15 September 2008.
Question
What benefit has Ratiograstim shown during the studies?
Answer
Treatment with Ratiograstim and Neupogen brought about similar reductions in duration of severe neutropenia. During the first 21-day chemotherapy cycle, patients treated with either Ratiograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo. Therefore, the effectiveness of Ratiograstim was shown to be equivalent to that of Neupogen.
Question
What is Ratiograstim?
Answer
Ratiograstim is a solution for injection or for infusion (drip into a vein). It contains the active substance filgrastim.
Ratiograstim is a ‘biosimilar medicine'. This means that Ratiograstim 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 Ratiograstim is Neupogen.
Question
What is Ratiograstim used for?
Answer
Ratiograstim 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 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.
Ratiograstim can also be used in patients 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.
Question
How has Ratiograstim been studied?
Answer
Ratiograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Ratiograstim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer. The study looked at the duration of severe neutropenia during the patients’ first cycle of cytotoxic chemotherapy.
To study the safety of Ratiograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin’s lymphoma.
Question
Why has Ratiograstim been approved?
Answer
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Ratiograstim 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 Ratiograstim be given marketing authorisation.
Question
What is the risk associated with Ratiograstim?
Answer
The most common side effect with Ratiograstim (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 Ratiograstim is being used for. For the full list of all side effects reported with Ratiograstim, see the package leaflet.
Ratiograstim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.