Filgrastim

NEUPOGEN is a leukocyte growth factor 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. Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT). Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.

Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation, differentiation commitment, and some end-cell functional activation. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes, fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation, differentiation, and selected end-cell functions (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst, antibody-dependent killing, and the increased expression of some cell surface antigens).

Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion. See Full Prescribing Information for recommended dosage adjustments and timing of administration. Patients with cancer undergoing bone marrow transplantation 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. Patients undergoing autologous peripheral blood progenitor cell collection and therapy 10 mcg/kg/day subcutaneous injection. Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis. Patients with congenital neutropenia Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily.

NEUPOGEN is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim. Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim.

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue NEUPOGEN in patients with ARDS. Serious allergic reactions, including anaphylaxis: Permanently discontinue NEUPOGEN in patients with serious allergic reactions. Fatal sickle cell crises: Discontinue NEUPOGEN if sickle cell crisis occurs. Glomerulonephritis: Evaluate and consider dose-reduction or interruption of NEUPOGEN if causality is likely. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using NEUPOGEN in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. Thrombocytopenia: Monitor platelet counts.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture Acute Respiratory Distress Syndrome Serious Allergic Reactions Sickle Cell Disorders Glomerulonephritis Alveolar Hemorrhage and Hemoptysis Capillary Leak Syndrome Myelodysplastic Syndrome Acute Myeloid Leukemia Thrombocytopenia Leukocytosis Cutaneous Vasculitis Large and Medium Vessel Arteritis Most common adverse reactions in patients: With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea. With AML (≥ 2% difference in incidence) are pain, epistaxis and rash. With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash.

Store NEUPOGEN vial refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage. Avoid freezing NEUPOGEN vial, if frozen, thaw in the refrigerator before administration. Store NEUPOGEN prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage. Avoid freezing NEUPOGEN prefilled syringe, if frozen, thaw in the refrigerator before administration. Do not shake. Do not shake.