Cancer Patients Receiving Myelosuppressive Chemotherapy
NEUPOGEN® is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever (see Clinical Experience). A complete blood count (CBC) and platelet count should be obtained prior to chemotherapy‚ and twice per week (see Laboratory Monitoring) during NEUPOGEN® therapy to avoid leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies‚ NEUPOGEN® therapy was discontinued when the ANC was ≥ 10‚000/mm3 after the expected chemotherapy-induced nadir.
Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy
NEUPOGEN® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML.
Cancer Patients Receiving Bone Marrow Transplant
NEUPOGEN® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg‚ febrile neutropenia‚ in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation (see Clinical Experience). It is recommended that CBCs and platelet counts be obtained at a minimum of 3 times per week (see Laboratory Monitoring) following marrow infusion to monitor the recovery of marrow reconstitution.
Patients Undergoing Peripheral Blood Progenitor Cell Collection and Therapy
NEUPOGEN® is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment compared with collection by leukapheresis without mobilization or bone marrow harvest. After myeloablative chemotherapy‚ the transplantation of an increased number of progenitor cells can lead...