Zuellig Pharma
Concise Prescribing Info
Reduction in duration of neutropenia & incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (except chronic myeloid leukemia & myelodysplastic syndrome). Reduction in duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation. Mobilisation of peripheral blood progenitor cells (PBPC). Increase neutrophil counts & reduce incidence & duration of infection-related events in patients w/ severe congenital cyclic or idiopathic neutropenia w/ ANC ≤0.5 x 109/L & history of severe or recurrent infections. Persistent neutropenia in patients w/ advanced HIV infection.
Dosage/Direction for Use
Established cytotoxic chemotherapy 5 mcg/kg daily SC inj or IV infusion over 30 min, 1st dose to be given at least 24 hr after cytotoxic chemotherapy. Patient treated w/ myeloablative therapy followed by bone marrow transplantation Initially 10 mcg/kg daily as 30-min or 24-hr IV infusion or continuous 24-hr SC infusion. 1st dose to be given at least 24 hr after cytotoxic chemotherapy or bone marrow infusion. Titrate dose against neutrophil response once neutrophil nadir has been passed. PBPC mobilisation in patient undergoing myelosuppressive or myeloablative therapy followed by autologous peripheral blood progenitor cell transplantation Monotherapy: 10 mcg/kg daily as 24-hr SC continuous infusion or SC inj for 5-7 consecutive days. Timing of leukapheresis: 1 or 2 leukaphereses on days 5 & 6, additional leukaphereses may be necessary. Maintain filgrastim dosing until last leukapheresis. Post-myelosuppressive chemotherapy 5 mcg/kg daily SC inj from 1st day of chemotherapy completion until expected neutrophil nadir is passed & neutrophil count has been to normal range. PBPC mobilisation in normal donor prior to allogeneic PBPC transplantation 10 mcg/kg daily SC inj for 4-5 consecutive days. Severe chronic & congenital neutropenia Initially 12 mcg/kg daily as single or in divided doses. Idiopathic or cyclic neutropenia Initially 5 mcg/kg daily SC inj as single or in divided doses. Initial dose may be doubled or halved depending upon patient's response after 1-2 wk. Patient w/ HIV infection Reversal of neutropenia: Initially 1 mcg/kg daily SC inj w/ titration up to max 4 mcg/kg daily until normal neutrophil count is reached & can be maintained. Maintaining normal neutrophil counts: Initial dose adjustment to alternate day dosing w/ 300 mcg daily SC inj. Ped use in severe chronic neutropenia & cancer setting Adult dose receiving myelosuppressive cytotoxic chemotherapy.
Special Precautions
Hypersensitivity to filgrastim or pegfilgrastim. Discontinue use in preliminary signs of adult resp distress syndrome, suspected or confirmed pulmonary adverse events; leukocyte count >50 x 109/L or >70 x 109/L (during PBPC mobilisation). Not to be used in myelodysplastic syndrome or chronic myelogenous leukaemia; severe congenital neutropenia w/ developed leukaemia or evidence of leukaemic evolution. Not be used to increase dose of cytotoxic chemotherapy beyond established dosage regimens. Glomerulonephritis; capillary leak syndrome; splenomegaly, splenic rupture; malignant cell growth; secondary AML; De novo AML patients <55 yr w/ good cytogenetics; thrombocytopenia; aortitis; sickle cell trait or sickle cell disease; high-dose chemotherapy; substantially reduced myeloid progenitors, bone marrow infiltration by tumour; vascular disorders; transient abnormal bone scans; autoimmune neutropenia; known bone marrow infiltrating infections or malignancy. Monitor bone density during continuous therapy >6 mth; urinalysis, spleen size, haematocrit, ANC, CBC w/ differential & platelet counts. Assessment of progenitor cell yields; PBPC mobilisation normal donors <16 & >60 yr, anticoagulated or known defects in haemostasis; increased risk of acute & chronic GvHD. Exclude causes of transient neutropenia eg, viral infections. Immunogenicity. Concomitant treatment w/ extensive RT or chemotherapy. Not to be given in patients w/ hereditary fructose intolerance. May affect ability to drive & use machines. Not recommended during pregnancy. Lactation. Neonates.
Adverse Reactions
Thrombocytopenia; anaemia; headache; diarrhoea, vomiting, nausea; alopecia; musculoskeletal pain; fatigue, mucosal inflammation. Sepsis, bronchitis, upper resp tract infection, UTI; splenomegaly, decreased Hb; decreased appetite, increased blood lactate dehydrogenase; insomnia; dizziness, hypo- & 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
Exacerbated severe neutropenia w/ 5-fluorouracil. Potentiated effect by lithium. Not recommended in the period from 24 hr before to 24 hr after chemotherapy.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Nivestim soln for inj/infusion (pre-filled syringe) 300 mcg/0.5 mL
0.5 mL x 10 × 1's
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