Rx Item-Neupogen Sglj 480Mcg 0.8 Syringe 10X0.8Ml By Amgen

NEUPOGEN- filgrastim injection, solution
Amgen Inc

1 INDICATIO NS AND USAGE

1.1 Patients with Cancer 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 Studies ( 14.1)].

1.2 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 patients with acute myeloid leukemia (AML) [see Clinical Studies ( 14.2)].

1.3 Patients with Cancer Undergoing Bone Marrow Transplantat ion
NEUPOGEN is indicated to 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 [see Clinical Studies ( 14.3)].

1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy
NEUPOGEN 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
NEUPOGEN is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.� fever� infections� oropharyngeal ulcers) in symptomatic patients with congenital neutropenia� cyclic neutropenia� or idiopathic neutropenia [see Clinical Studies ( 14.5)].

1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
NEUPOGEN is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies ( 14.6)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Patients with Cancer Receiving Myelosuppressive Chemotherapy or Induction and/or Consolidation C hemotherapy for AML
The recommended starting dosage of NEUPOGEN is 5 mcg/kg/day� administered as a single daily injection by subcutaneous injection� by short intravenous infusion (15 to 30 minutes)� or by continuous intravenous infusion. Obtain a complete blood count (CBC) and platelet count before instituting NEUPOGEN therapy and monitor twice weekly during therapy. Consider dose escalation in increments of 5 mcg/kg for each chemotherapy cycle� according to the duration and severity of the absolute neutrophil count (ANC) nadir. Recommend stopping NEUPOGEN if the ANC increases beyond 10�000/mm3 [see Warnings and Precautions ( 5.10)].

Administer NEUPOGEN at least 24 hours after cytotoxic chemotherapy. Do not administer NEUPOGEN within the 24-hour period prior to chemotherapy [see Warnings and Precautions ( 5.13)]. A transient increase in neutrophil count is typically seen 1 to 2 days after initiation of NEUPOGEN therapy. Therefore, to ensure a sustained therapeutic response� administer NEUPOGEN daily for up to 2 weeks or until the ANC has reached 10�000/mm3 following the expected chemotherapy-induced neutrophil nadir. The duration of NEUPOGEN therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.

2.2 Dosage in Patients with Cancer Undergoing Bone Marrow Transplantation
The recommended dosage of NEUPOGEN following bone marrow transplantation (BMT) is 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. Administer the first dose of NEUPOGEN at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion. Monitor CBCs and platelet counts frequently following marrow transplantation.

RX ITEM-Neupogen Sglj 480Mcg 0.8 Syringe
NDC 55513-0209-10 UPC/GTIN No.3-55513-20910-6 Mfg.Part No.20910

Neupogen Sglj 480Mcg 0.8 Syringe 10X0.8M
BRAND: NEUPOGEN NDC: 55513-0209-10,55513020910 UPC: 3-55513-20910-6,355513209106

FILGRASTIM INJECTION SYRI
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