Zuellig Pharma
Concise Prescribing Info
Reduction in the duration of neutropenia & the incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (w/ the exception of chronic myeloid leukaemia & myelodysplastic syndromes) & for the reduction in the duration of neutropenia & its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. Mobilisation of autologous peripheral blood progenitor cells alone or following myelosuppressive chemotherapy & the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic PBPC). In patients, childn or adults w/ severe congenital, cyclic or idiopathic neutropenia w/ an absolute neutrophil count (ANC) ≤0.5 x 109/L & history of severe or recurrent infections to increase neutrophil counts & to reduce the incidence & duration of infection-related events. Persistent neutropenia (ANC ≤1 x 109/L) in patients w/ advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Dosage/Direction for Use
Established cytotoxic chemotherapy 0.5 MU (5 mcg)/kg/day as a daily SC inj or 30-min IV infusion. Patient treated w/ myeloablative therapy followed by bone marrow transplantation 1 MU (10 mcg)/kg/day as a 30-min or 24-hr IV infusion or by continuous 24-hr SC infusion. Mobilisation of PBPC in patient undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation w/ or w/o bone marrow transplantation PBPC mobilisation when used alone: 1 MU (10 mcg)/kg/day as a 24-hr continuous SC infusion or a single daily SC inj for 5-7 consecutive days. PBPC mobilisation after myelosuppressive chemotherapy: 0.5 MU (5 mcg)/kg/day by SC inj from the 1st day after completion of chemotherapy until the expected neutrophil nadir is passed & neutrophil count has recovered to normal range. Mobilisation of PBPC in normal donors prior to allogeneic PBPC transplantation 10 mcg/kg/day SC for 4-5 consecutive days. Congenital neutropenia Initially 1.2 MU (12 mcg)/kg/day SC in single or divided doses. Idiopathic or cyclic neutropenia Initially 0.5 MU (5 mcg)/kg/day SC in single or divided doses. HIV infection Reversal of neutropenia: Initially 0.1 MU (1 mcg)/kg/day SC w/ titration up to max 0.4 MU (4 mcg)/kg/day until a normal neutrophil count is reached & can be maintained (ANC >2 x 109/L). Maintaining normal neutrophil counts: Alternate-day dosing w/ 30 MU (300 mcg)/day SC.
Special Precautions
Do not use to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Do not administer in patients w/ severe congenital neutropenia (who develop leukaemia or have evidence of leukaemic evolution); history of hypersensitivity to filgrastim or pegfilgrastim. Potential for immunogenicity. Patients w/ myelodysplastic syndrome or chronic myelogenous leukaemia; secondary AML; <55 yr w/ good cytogenetics (t(8;21), t(15;17) & inv(16)); severe chronic neutropenia (SCN) who develop abnormal cytogenetics; sickle cell trait/disease. Monitor bone density in patients w/ underlying osteoporotic bone diseases who undergo continuous Neupogen therapy for >6 mth. Discontinue in case of preliminary signs of acute resp distress syndrome. Closely monitor patients who develop symptoms of capillary leak syndrome; aortitis. Monitor spleen size (risk of splenomegaly & splenic rupture), WBC, platelet count & hematocrit; urinalysis; ANC especially during the 1st few wk of therapy. Patients on high-dose chemotherapy. Neutrophil response may be diminished in patients w/ reduced precursors (eg, those treated w/ extensive radiotherapy or chemotherapy, or those w/ bone marrow infiltration by tumour). Transient abnormal bone scans. Exclude causes of transient neutropenia eg, viral infections. Patients & neonates w/ autoimmune neutropenia. Should not be taken by patients w/ rare hereditary problems of fructose intolerance. Pregnancy. Lactation (not recommended). Childn (normal donors <16 yr). Elderly (normal donors >60 yr).
Adverse Reactions
Cancer patients: Increased blood uric acid & lactate dehydrogenase, decreased appetite; headache; oropharyngeal pain, cough, dyspnoea; diarrhoea, vomiting, constipation, nausea; increased γ-glutamyl transferase & blood alkaline phosphatase; rash, alopecia; musculoskeletal pain; asthenia, fatigue, mucosal inflammation, pain. Drug hypersensitivity; hypotension; haemoptysis; dysuria; chest pain. PBPC mobilisation in normal donors: Thrombocytopenia, leukocytosis; headache; musculoskeletal pain. Splenomegaly; increased blood lactate dehydrogenase; dyspnoea; increased blood alkaline phosphatase. SCN patients: Splenomegaly, anaemia; hyperuricaemia, decreased blood glucose & increased blood lactate dehydrogenase; headache; epistaxis; diarrhoea; hepatomegaly, increased blood alkaline phosphatase; rash; musculoskeletal pain, arthralgia. Splenic rupture, thrombocytopenia; cutaneous vasculitis, alopecia; osteoporosis; haematuria, glomerulonephritis; inj site reaction. HIV patients: Musculoskeletal pain. Splenomegaly.
Drug Interactions
Neutropenia severity may be exacerbated w/ 5-fluorouracil. Potentiated effect w/ lithium.
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Neupogen soln for inj 30 Million unit/0.5 mL
0.5 mL x 1's
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