Concise Prescribing Info
Reduction in the duration of neutropenia & the incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (except chronic myeloid leukemia & myelodysplastic syndromes), & in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia; mobilization of peripheral blood progenitor cells (PBPC). Increase neutrophil counts & to reduce the incidence & duration of infection-related events in adult & childn w/ severe congenital, cyclic or idiopathic neutropenia w/ an ANC ≤0.5 x 109/L, & a history of severe or recurrent infections. Treatment of persistent neutropenia (ANC ≤1 x 109/L) w/ advanced HIV infection.
Dosage/Direction for Use
Established cytotoxic chemotherapy 5 mcg/kg/day. 1st dose should be administered at least 24 hr after cytotoxic chemotherapy by daily by SC inj or IV infusion. Patients treated w/ myeloablative therapy followed by bone marrow transplantation 10 mcg/kg/day. 1st dose should be administered at least 24 hr after bone marrow infusion given as 30 min or 24 hr IV infusion or by continuous 24 hr SC infusion. Mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation 10 mcg/kg/day for 5-7 consecutive days by 24 hr SC continuous infusion or SC inj. PBPC mobilization after myelosuppressive chemotherapy 5 mcg/kg/day by SC inj from the 1st day after completion of chemotherapy until expected neutrophil nadir is passed & the neutrophil count has recovered to the normal range. Mobilisation of PBPCs in normal donors prior to allogenic PBPC transplantation 10 mcg/kg/day for 4-5 consecutive days by SC inj. Patients w/ severe chronic neutropenia: Congenital neutropenia 12 mcg/kg/day by SC inj as a single dose or in divided doses. Idiopathic or cyclic neutropenia 5 mcg/kg/day by SC inj as a single dose or in divided doses. Patients w/ HIV infection (reversal of neutropenia) 1 mcg/kg/day, max of 4 mcg/kg/day by SC inj.
Special Precautions
Hypersensitivity. Pulmonary adverse effects, in particular interstitial lung disease; patients w/ a recent history of lung infiltrates or pneumonia may be at higher risk; glomerulonephritis; capillary leak syndrome; splenomegaly & splenic rupture; malignant cell growth; myelodysplastic syndrome or chronic myeloid leukemia; acute myeloid leukemia; thrombocytopenia; leukocytosis; immunogenicity; aortitis. Consider temporary discontinuation or dose reduction in patients w/ severe chronic neutropenia who develop thrombocytopenia (platelet count <100 x 109/L). Discontinue immediately if leukocyte counts >50 x 109/L after the expected nadir. Sickle cell trait & disease; osteoporosis. Should not be used to increase dose of cytotoxic chemotherapy beyond established dosage regimens. Risks associated with increased doses of chemotherapy. Anaemia. Diminished response in patients w/ reduced neutrophil precursors; vascular disorders including veno-occlusive disease & fluid disturbances; GvHD & fatalities; increased haematopoietic activity of the bone marrow. Avoid in patients w/ rare hereditary problems of fructose intolerance. Monitor urinalysis; spleen size. Monitor WBC; platelet count & haematocrit regularly. May have minor influence on the ability to drive & use machines. Not recommended in pregnancy. Lactation. Elderly. PBPC mobilisation: Normal donors <16 yr or >60 yr. Should not be performed in donors who are anticoagulated or who have known defects in haemostasis. Monitor donors who receive G-CSFs until haematological indices return to normal. Transient cytogenetic abnormalities have been observed in normal donors. Increased risk of acute & chronic GvHD between allogeneic PBPC graft & the recipient. SCN patients: Do not administer to patients w/ severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution. Perform CBC counts w/ differential & platelet counts, & an evaluation of bone marrow morphology & karyotype prior to treatment. Perform morphologic & cytogenic bone marrow exam at regular intervals (approx every 12 mth). Neonates & patients w/ autoimmune neutropenia. Patients w/ HIV infection: Monitor absolute neutrophil count especially during the first few wk at least twice a wk for the 1st 2 wk & subsequently once a wk or once every other wk.
Adverse Reactions
Thrombocytopenia, anaemia; headache; diarrhoea, vomiting, nausea; alopecia; musculoskeletal pain; fatigue, mucosal inflammation, pyrexia. Sepsis, bronchitis, upper resp tract infection, UTI; splenomegaly, decreased Hg; decreased appetite, increased blood lactated dehydrogenase; insomnia; dizziness, hypoaesthesia, paraesthesia; HTN, hypotension; haemoptysis, dyspnoea, cough, oropharyngeal pain, epistaxis; oral pain, constipation; hepatomegaly, increased blood alkaline phosphatase; rash, erythema; muscle spasms; dysuria, haematuria; chest pain, pain, asthenia, malaise, peripheral oedema; transfusion reaction.
Drug Interactions
May exacerbate severity of neutropenia w/ 5-fluorouracil. May likely potentiate the effect w/ lithium.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Neupogen soln for inj 300 mcg/mL
4 × 1's
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