Zefylti 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. Zefylti 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. Zefylti contains the active substance filgrastim and is a biological medicine. It is a ‘biosimilar medicine’; this means that Zefylti is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zefylti is Neupogen. For more information on biosimilar medicines, see [here](https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines).
Therapeutic Indication
### Therapeutic indication Zefylti 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 Zefylti are similar in adults and children receiving cytotoxic chemotherapy. Zefylti 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 Zefylti is indicated to increase neutrophil counts and to reduce the incidence and duration of infection related events. Zefylti is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1 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.
Therapeutic Area (MeSH)
ATC Code
L03AA02
ATC Item
filgrastim
Pharmacotherapeutic Group
Immunostimulants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| filgrastim | N/A | 非格司亭 |
EMA Name
Zefylti
Medicine Name
Zefylti
Aliases
N/ANo risk management plan link.
