FILGRASTIM-AAFI (Nivestym) Nursing Considerations

What is the generic name?

FILGRASTIM-AAFI

What is the Trade Name for FILGRASTIM-AAFI?

Nivestym

What are the Indications for FILGRASTIM-AAFI?

• 1 INDICATIONS AND USAGE NIVESTYM is a leukocyte growth factor indicated to Decrease the incidence of infection‚Äö as manifested by febrile neutropenia‚Äö in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚Äö e.g.‚Äö febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT). ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚Äö fever‚Äö infections‚Äö oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚Äö cyclic neutropenia‚Äö or idiopathic neutropenia. ( 1.5 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NIVESTYM is indicated to decrease the incidence of infection‚Äö as manifested by febrile neutropenia‚Äö in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NIVESTYM is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NIVESTYM is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚Äö e.g.‚Äö febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ]. 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NIVESTYM is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NIVESTYM is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚Äö fever‚Äö infections‚Äö oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚Äö cyclic neutropenia‚Äö or idiopathic neutropenia [see Clinical Studies (14.5) ] .

References: https://open.fda.gov/