Zarzio

Filgrastim

Reduction in duration of neutropenia & incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (w/ exception of chronic myeloid leukaemia & myelodysplastic syndromes). Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. Mobilisation of peripheral blood progenitor cells (PBPC). Increase neutrophil counts & reduce incidence & duration of infection-related events in adults & childn w/ severe congenital, cyclic or idiopathic neutropenia w/ an absolute neutrophil count (ANC) of ≤0.5 x 10⁹/L & history of severe or recurrent infections. Treatment of persistent neutropenia (ANC ≤1 x 10⁹/L) in patients w/ advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

Cytotoxic chemotherapy 0.5 MU/kg/day SC inj or IV infusion over 30 min. 1st dose to be administered at least 24 hr after cytotoxic chemotherapy. Myeloablative therapy followed by bone marrow transplantation 1 MU/kg/day given as 30-min or 24-hr IV infusion or by continuous 24-hr SC infusion. 1st dose to be administered at least 24 hr after cytotoxic chemotherapy & at least 24 hr after bone marrow infusion. Mobilisation of PBPC Patient undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation 1 MU/kg/day continuous SC infusion over 24 hr for 5-7 consecutive days. After myelosuppressive therapy: 0.5 MU/kg/day from the 1st day after completion of chemotherapy until expected neutrophil nadir has passed & neutrophil count has recovered to normal range. Normal donors prior to allogeneic PBPC transplantation 1 MU/kg/day SC inj for 4-5 consecutive days. Severe chronic congenital neutropenia Initially 1.2 MU/kg/day SC inj as single dose or in divided doses until neutrophil count has reached & can be maintained at >1.5 x 10⁹/L. Severe chronic idiopathic or cyclic neutropenia Initially 0.5 MU/kg/day SC inj as single dose or in divided doses until neutrophil count has reached & can be maintained at >1.5 x 10⁹/L. Reversal of neutropenia in HIV patients Initially 0.1 MU/kg/day SC inj daily w/ titration up to max of 0.4 MU/kg/day until normal neutrophil count is reached & can be maintained (ANC >2 x 10⁹/L). Maintenance: 30 MU/day.

Hypersensitivity.

Risk of hypersensitivity, including anaphylactic reactions; pulmonary adverse effects particularly interstitial lung disease; glomerulonephritis; capillary leak syndrome; splenomegaly & splenic rupture; thrombocytopenia; leukocytosis; sickle cell crises in patients w/ sickle cell trait or disease; vascular disorders in patients undergoing high-dose chemotherapy followed by transplantation; Graft versus Host Disease (GvHD) in patients receiving G-CSF after allogeneic bone marrow transplantation; transient abnormal bone scans; aortitis; transient cytogenetic abnormalities in normal donors following G-CSF use; haematuria, proteinuria. Caution in patients w/ secondary acute myelogenous leukaemia; when treating patients w/ high-dose chemotherapy; patients w/ known bone marrow-infiltrating infections or malignancy; latex-sensitive individuals; patients w/ hereditary fructose intolerance. Not indicated for use in myelodysplastic syndrome or chronic myelogenous leukaemia. Potential for immunogenicity. Monitor bone density in patients w/ underlying osteoporotic bone diseases who undergo continuous therapy w/ filgrastim for >6 mth. Should not be used to increased dose of cytotoxic chemotherapy beyond established dosage regimens. Regular monitoring of platelet count & haematocrit is recommended. Neutrophil response may be diminished in patients w/ substantially reduced myeloid progenitors. Should not be administered to patients w/ severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution. Closely monitor ANC, especially during the 1st few wk of therapy. G-CSF can promote growth of myeloid cells in vitro & similar effects may be seen on some nonmyeloid cells in vitro. Minor influence on the ability to drive & use machines. Not recommended during pregnancy. Lactation.

Pyrexia, musculoskeletal pain (including bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, nausea. Thrombocytopenia, headache, diarrhoea, alopecia, fatigue; mucosal inflammation.

Use of filgrastim is not recommended in the period from 24 hr before to 24 hr after chemotherapy. Severity of neutropenia may be exacerbated w/ 5-fluorouracil. Potentiated effect w/ lithium.

Haematopoietic Agents / Supportive Care Therapy

L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.

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