White blood cell growth factors, also known as granulocyte colony stimulating factors (G-CSF), are administered to enhance recovery of blood related functions in neutropenia (low white blood count) including febrile neutropenia (FN). G-CSF is classified as a recombinant hematopoietic stimulant. This is not a cancer chemotherapy agent. It is a class II hematopoietic growth factor which acts on progenitor cells capable of forming a single differentiated cell type, the neutrophilic granulocyte, and is thus lineage-specific.
CSFs are also utilized to decrease the incidence and severity of infection associated with select disease-related and drug-related myelosuppression (inhibition of bone marrow function).
General Information
Pegfilgrastim is approved by the Food and Drug Administration to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Prophylactic use of pegfilgrastim in patients undergoing chemotherapy reduces the risk of febrile neutropenia and infections. Prophylactic therapy can be considered for patients receiving myelosuppressive chemotherapy if the risk of febrile neutropenia is 20% or greater.
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf are leukocyte growth factors indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf are biosimilar* to pegfilgrastim.
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information).
