Zuellig Pharma
Concise Prescribing Info
Reduction in the duration of neutropenia & incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (w/ exception of chronic myeloid leukemia & 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. Mobilization of peripheral blood progenitor cells (PBPC). Severe congenital, cyclic or idiopathic neutropenia & history of severe or recurrent infections. Persistent neutropenia in patients w/ advanced HIV infection.
Dosage/Direction for Use
Established cytotoxic chemotherapy 0.5 MU/kg daily as SC inj or IV infusion over 30 min. Patient treated w/ myeloablative therapy followed by bone marrow transplantation Initially 1 MU/kg daily as 30-min or 24-hr IV infusion or continuous 24-hr SC infusion. PBPC mobilization in patient undergoing myelosuppressive therapy followed by autologous PBPC transplantation Monotherapy: 1 MU/kg daily as 24-hr SC continuous infusion or SC inj for 5-7 days. After myelosuppressive chemotherapy: 0.5 MU/kg daily SC inj. PBPC mobilization in normal donor prior to allogeneic PBPC transplantation 1 MU/kg daily SC inj for 4-5 consecutive days. Severe chronic neutropenia Initially 1.2 MU/kg daily SC inj as single or in divided doses. Idiopathic or cyclic neutropenia Initially 0.5 MU/kg daily SC inj as single or in divided doses. Reversal of neutropenia in HIV infected patient Initially 0.1 MU/kg daily SC inj w/ titration up to max: 0.4 MU/kg daily. Maintenance: Initial dose adjustment to alternate day dosing w/ 30 MU daily SC inj.
Special Precautions
Hypersensitivity. Not to be used in myelodysplastic syndrome or chronic myelogenous leukemia. Recent history of pulmonary infiltrates or pneumonia; glumerulonephritis; malignant cell growth; secondary AML, De novo AML patients <55 yr. Immunogenicity; aortitis; sickle cell trait or disease; osteoporis; vascular disorders. Not to perform leukapheresis in anticoagulated donors or w/ known haemostasis defect. Not to be used in patients w/ severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution. Patients w/ reduced precursors neutrophil response; autoimmune neutropenia; bone marrow infiltrating infections or malignancy. Monitor for preliminary signs of acute resp distress syndrome; urinalysis; bone density. Closely monitor patients who develop capillary leak syndrome & spleen size. Monitor for signs & symptoms of myelodysplastic syndrome/AML in patients w/ breast & lung cancer. Regularly perform CBC count w/ differential & platelet counts; hematocrit levels. Perform morphologic and cytogenetic bone marrow exam at regular intervals. Normal donors <16 or >60 yr. May cause allergic reactions due to latex. High-dose use. Not to be given in patients w/ fructose intolerance. May affect ability to drive & use machines. Not recommended during pregnancy. Lactation. Neonates, babies & young childn <2 yr.
Adverse Reactions
Thrombocytopenia, anaemia; headache; diarrhoea, vomiting, nausea; alopecia; musculoskeletal pain; fatigue, mucosal inflammation, pyrexia. Sepsis, bronchitis, upper resp tract infection, UTI; splenomegaly; decreased Hb; decreased appetite, increased blood LDH; 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
Myelosuppressive cytotoxic chemotherapy. Exacerbated severity of neutropenia w/ 5-fluorouracil.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Neupogen inj (pre-filled syringe) 30 Million unit/mL
Neupogen inj (vial) 30 Million unit/mL
5 × 1's
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