Leucogen
Filgrastim is a human granulocyte colony-stimulating factor (G-CSF), produced by DNA technology in strain of Escherichia coli. Filgrastim is nonglycosylated protein comprising 175 amino acids.
Composition
Filgrastim (rh G-CSF) 300 μg
Indication
For reduction time of neutropenia in patient with solid tumor or non-myeloid malignancy undergoing cytotoxic myelosuppresive chemotherapy
For reduction time of neutropenia in patient with solid tumor or non-myeloid malignancy undergoing cytotoxic myelosuppresive chemotherapy
Contra Indication
Patients with known hypersensitivity to Escherichia coli derived protein, Filgastrim or its constituents.
Patients with myeloid malignancy.
Filgastrim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Patients with known hypersensitivity to Escherichia coli derived protein, Filgastrim or its constituents.
Patients with myeloid malignancy.
Filgastrim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Warning
Use of Filgastrim is not recommended in myeloid premalignant and malignant condition.
A white blood cell count should be performed at regular intervals during Filgastrim therapy. If leucocyte counts exceed 50 x 109/l after the expected nadir, Filgastrim should be discontinued immediately.
Monitoring of bone density may be indicated in patients with underlying osteoporotic bone disease who receive Filgastrim Studies have not been performed with filgastrim in patients with severe impairment of renal or hepatic function and therefore, its use in this patient group cannot be recommended.
The safety of Filgastrim has hot been established in children
Use of Filgastrim is not recommended in myeloid premalignant and malignant condition.
A white blood cell count should be performed at regular intervals during Filgastrim therapy. If leucocyte counts exceed 50 x 109/l after the expected nadir, Filgastrim should be discontinued immediately.
Monitoring of bone density may be indicated in patients with underlying osteoporotic bone disease who receive Filgastrim Studies have not been performed with filgastrim in patients with severe impairment of renal or hepatic function and therefore, its use in this patient group cannot be recommended.
The safety of Filgastrim has hot been established in children
Adverse Reaction
Mild-moderate musculoskeletal pain during treatment, though severe cases occasionally appear. Less frequent adverse events include dysuria, thrombositopenia, splenomegaly, anemia, epistaxis, cephalgia, diarrhea and vasculitis.
Reversible, dose-dependent and usually mild or moderate elevations of enzyme lactate dehydrogenase, alkaline phosphatase, serum uric acid and -glutamyl transpeptidase may frequently occur.
Mild-moderate musculoskeletal pain during treatment, though severe cases occasionally appear. Less frequent adverse events include dysuria, thrombositopenia, splenomegaly, anemia, epistaxis, cephalgia, diarrhea and vasculitis.
Reversible, dose-dependent and usually mild or moderate elevations of enzyme lactate dehydrogenase, alkaline phosphatase, serum uric acid and -glutamyl transpeptidase may frequently occur.
Dosage
Recommended Dose: 5 μg/kg body weight once daily, SC bolus injection or as a short IV infusion, diluted in 5% glucose solution, given over 30 minutes.
LEUCOGEN® should be administered daily for up to 2 weeks, until the ANC has reached 10,000/mm3 following the expected chemotherapy-induced neutrophil nadir.
The duration of LEUCOGEN® therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.
LEUCOGEN® therapy should be discontinued if the ANC surpasses 10,000/mm3 after the expected chemotherapy-induced neutrophil nadir.
LEUCOGEN® should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. LEUCOGEN® should not be administered in the period 24 hours before the administration of chemotherapy.
Recommended Dose: 5 μg/kg body weight once daily, SC bolus injection or as a short IV infusion, diluted in 5% glucose solution, given over 30 minutes.
LEUCOGEN® should be administered daily for up to 2 weeks, until the ANC has reached 10,000/mm3 following the expected chemotherapy-induced neutrophil nadir.
The duration of LEUCOGEN® therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.
LEUCOGEN® therapy should be discontinued if the ANC surpasses 10,000/mm3 after the expected chemotherapy-induced neutrophil nadir.
LEUCOGEN® should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. LEUCOGEN® should not be administered in the period 24 hours before the administration of chemotherapy.
Presentation
Box of 1 Vial @ 300 μg/mL x 1 mL
Box of 1 Vial @ 300 μg/mL x 1 mL
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