Basic Information
Nivestim
Regulatory Information
EMEA/H/C/001142
June 7, 2010
March 18, 2010
31
October 17, 2024
Company Information
Belgium
Boulevard de la Plaine 17 1050 Bruxelles
Pfizer Europe MA EEIG
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Filgrastim 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. Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). 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 filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim 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
Nivestim is a medicine that stimulates the production of white blood cells and is used: - to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes). Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections. - to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at 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. Nivestim can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow. Nivestim is a ‘biosimilar’ medicine. This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Nivestim is Neupogen. For more information on biosimilar medicines, see below. Nivestim contains the active substance filgrastim.