Filgrastim is indicated to those: Cancer patients receiving myelosuppressive chemotherapy Patients with Acute Myeloid Leukemia receiving induction or consolidation chemotherapy Cancer patients receiving bone marrow transplant Patients with severe neutropenia Peripheral blood progenitor cell collection and therapy
Filgrastim is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation and differentiation. It also causes the enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst, antibody-dependent killing and the increased expression of some cell surface antigens.
Filgrastim exhibits nonlinear pharmacokinetics. Clearance is dependent on Filgrastim concentration and neutrophil count. Filgrastim is cleared by kidney. It has a tmax of 2 to 8 hours. The absolute bioavailability of Filgrastim after subcutaneous administration is 60-70%.
Parenteral- Chemotherapy-induced neutropenia: 5 mcg/kg daily as a single daily SC inj, as a continuous IV or SC infusion, or as a daily IV infusion over 15-30 minutes, starting not Bone marrow transplantation: 10 mcg/kg daily by IV infusion over 30 min or 4 hr or continuous IV or SC infusion over 24 hr. Adjust according to response. Subcutaneous- Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation: 10 mcg/kg daily, as a single inj or by continuous infusion, for 4-7 days until the last leucapheresis procedure. If it is given after myelosuppressive chemotherapy: 5 mcg/kg daily by inj; given from the 1st day after chemotherapy completion until expected neutrophil nadir is passed and neutrophil count has returned to normal range, so that leucapheresis can be performed. Congenital neutropenia: 12 mcg/kg daily in single or divided doses. Adjust according to response. In patients with cyclic or idiopathic neutropenia: 5 mcg/kg daily in single or divided doses. Adjust according to response. HIV infection and persistent neutropenia: Initially, 1 mcg/kg daily. Dose may be increased to 4 mcg/kg daily until normal neutrophil count is achieved. Maintenance: 300 mcg daily. Max: 4 mcg/kg daily.
Drug Interactions between Filgrastim and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as Lithium should be used with caution.
Filgrastim is contraindicated in patients hypersensitive to the drug, any ingredient in the formulation, or proteins derived from Escherichia coli. Filgrastim should not be administered within 24 hours before and after chemotherapy The possibility of Filgrastim acting as a growth factor for any tumor type cannot be excluded. To avoid adverse effects of excessive neutrophils complete blood count is recommended twice per week during treatment. Filgrastim is given by subcutaneous or intravenous infusion as required.
Musculoskeletal pain, bone pain, hypersensitivity reactions, splenic enlargement, hepatomegaly, thrombocytopaenia, anaemia, epistaxis, headache, nausea, vomiting, diarrhoea, urinary abnormalities (dysuria, proteinuria, haematuria), osteoporosis, exacerbation of rheumatoid arthritis, transient decrease in blood glucose, raised uric acid, cutaneous vasculitis, transient hypotension.
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
The maximum tolerated dose of Filgrastim has not been determined. Patients in the BMT studies received up to 13.8 MU(138 mcg)/kg/day without toxic effects.
Refrigerate at 2-8° C. Protect from light. Do not freeze & avoid shaking.
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