NEUPOGEN® (Filgrastim) - Hematopoietic Growth Factor Size：27.50 K | View：145 | Page：1NEUPOGEN® (Filgrastim) - Hematopoietic Growth Factor Neupogen® is a highly purified non-glycosylated proteincomprising 175 amino acids. Neupogen® is produced in alaboratory strain of Escherichia coli bacteria which has been geneticallyaltered by the addition of a gene for the granuloc...
NEUPOGEN® (Filgrastim) - Hematopoietic Growth Factor Neupogen® is a highly purified non-glycosylated proteincomprising 175 amino acids. Neupogen® is produced in alaboratory strain of Escherichia coli bacteria which has been geneticallyaltered by the addition of a gene for the granulocyte colony-stimulatingfactor. Neupogen® is supplied as:-a) 1 vial of Neupogen® of 1.0 mlinjection solution contains 30 MU (=300 ug) of filgrastim.b) 1 pre-filled syringe of Neupogen® of0.5 ml injection solution contains 30 MU (=300 ug) filgrastim.Excipients: sodium acetate buffer (pH 4.0),sorbitol, polysorbate 80, water for injection. *G-CSF stands for non-glycosylated recombinant human methionylgranulocyte colony-stimulating factor. Human granulocyte colony-stimulating factor is a glycoprotein whichregulates the production and release of functional neutrophils from the bonemarrow. Neupogen®, containing recombinant G-CSF, causes markedincreases in peripheral blood neutrophil counts within 24 hours, with minorincreases in monocytes. In some severe chronic neutropenia patientsNeupogen® can also induce a minor increase in the number ofcirculating eosinophils and basophils relative to baseline; some of thesepatients may present with eosinophilia or basophilia already prior totreatment. Elevations of neutrophil counts are dose-dependent at recommendeddoses. Neutrophils produced by the human body in response to Neupogen®show normal or enhanced function as demonstrated by tests of chemotacticand phagocytic function. Following termination of Neupogen® therapy,circulating neutrophil counts decrease by 50% within one to two days, and tonormal levels within one to seven days. Treatment with Neupogen® leads to significant reductionsin the incidence, severity and duration of neutropenia and febrile neutropeniafrequently observed in patients undergoing cytotoxic chemotherapy ormyeloablative therapy followed by bone marrow transplantation. Patients treated with Neupogen® and cytotoxicchemotherapy or myeloablative therapy followed by bone marrow transplantationrequire fewer admissions to hospital, shorter durations of hospitalization andless antibiotics compared to patients with cytotoxic chemotherapy alone. Use of Neupogen®, either alone or after chemotherapy,mobilizes hematopoetic progenitor cells into the peripheral blood. Theseautologous Peripheral Blood Progenitor Cells (PBPCs) may be harvested andinfused after high-dose cytotoxic therapy, either in place of, or in additionto bone marrow transplantation. Infusion of PBPCs accelerateshemotopoetic recovery reducing the duration of risk for hemorrhagiccomplications and the need for platelet transfusions. Use of Neupogen® in patients, children or adults, withsevere chronic neutropenia (severe congenital, cyclic and idiopathicneutropenia) induces a sustained increase in absolute neutrophil counts inperipheral blood and a reduction of infection and related events. Neupogen® is indicated for reduction in the duration ofneutropenia and the incidence of febrile neutropenia in patients treated withestablished cytotoxic chemotherapy for non-myeloid malignancy and for thereduction in the duration of neutropenia and its clincal sequelae in patientsundergoing myeloablative therapy followed by bone marrow transplantation. Neupogen® in indicated for the mobilization of autologousperipheral blood progenitor cells alone, or following myelosuppressivechemotherapy in order to accelerate hematopoietic recovery by infusion of suchcells, after myelosuppressive or myeloablatively therapy. In patients, children or adults, with severe congenital, cyclic oridiopathic neutropenia with an ANC of 9/l, and a history of severe or recurrent infections, long-termadministration of Neupogen® is indicated to increase neutrophilcounts and to reduce the incidence and duration of infection-related events. The recommended dose of Neupogen® is 0.5 MU (5ug)/kgbodyweight once daily.In patients treated with myeloablative therapy followed by bonemarrow transplantation, the recommended starting dose of Neupogen® is1.0 MU (10ug)/kg/day given as a 30 minutes or 24 hours intravenous infusion or1.0 MU (10ug)kg/day given by continuous 24 hours subcutaneous infusion. Neupogen® should be diluted in 20 ml of 5% glucose solution (seeinstruction for dilution). The first dose of Neupogen® should not be administeredwithin 24 hours of cytotoxic chemotherapy or bone marrow infusion. Once the neutrophil nadir has been passed, the daily dose ofNeupogen® should be titrated against the neutrophil response asfollows: > Neutrophil count Neupogen dose adjustment >1.0 x 109/l for 3 consecutive days Reduce to 0.5 MU/kg/day Then, if ANC remains >1.0 x 109/l for 3 more consecutive days Discontinue Neupogen If the ANC decreases to 9/l during the treatment period, the dose of Neupogen should be re-escalated according to the above steps. ANC = absolute neutrophil count In patients undergoing peripheral blood progenitor cell mobilizationFor the mobilization of PBPCs in patients undergoingmyelosuppressive or myeloablative therapy followed by autologous PBPCtransplantation with or without bone marrow transplantation. Therecommended dose of Neupogen® for PBPC mobilization when used aloneis 1.0 MU (10ug)/kg/day as a 24-hour subcutaneous continuous infusion, or asingle daily subcutaneous injection for 6 consecutive days. For infusionsNeupogen® should be diluted in 20 ml of 5% glucose solution (seeinstructions for dilution). Timing of leukapheresis: a total of three consecutivecollections is recommended, on days 5, 6 and 7. The recommended dose of Neupogen® for PBPCcombilization after myelosuppressive chemotherapy is 0.5 MU (5ug)/kg/day givendaily by subcutaneous injection from the first day after completion of chemotherapyuntil the expected neutrophil nadir is passed and the neutrophil count hasrecovered to the normal range. Leukapheresis should be performed duringthe period when the ANC rises from 9/l to >5.0 x 109/l. For patients who have not had extensive chemotherapy, oneleukapheresis is often sufficient. In other circumstances, additionalleukapheresis are recommended. StabilityNeupogen® should be stored in a refrigerator at2-8ºC. Accidental exposure to freezing temperatures does not adverselyaffect the stability of Neupogen®. Diluted Neupogen® solutions should not be prepared morethan 24 hours before administration and should also be stored refrigerated at2-8ºC. Neupogen® vials and pre-filledsyringes are for single-dose use only.