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. Do not give 1st dose <24 hr following 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. Do not give 1st dose <24 hr following cytotoxic chemotherapy or w/in 24 hr of bone marrow infusion. Titrate dose against neutrophil response once neutrophil nadir has been passed. Mobilisation of PBPC 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 single daily 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. Mobilisation of PBPC in normal donor prior to allogeneic peripheral blood progenitor cell transplantation 10 mcg/kg daily SC inj for 4-5 consecutive days. Patient w/ severe chronic & congenital neutropenia Initially 12 mcg/kg daily as single dose or in divided doses. Idiopathic or cyclic neutropenia Initially 5 mcg/kg daily SC inj as single dose or divided doses. Dose adjustment: 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 Same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Hypersensitivity. Fructose intolerance.
Special Precautions
Not be used in severe congenital neutropenia (Kostmann's syndrome) w/ abnormal cytogenetics. Myelodysplastic syndrome or chronic myelogenous leukaemia. Secondary AML. De novo AML patients <55 yr w/ good cytogenetics. Monitor bone density during continuous therapy >6 mth; complete blood & platelet counts; spleen size urinalysis, ANC. 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); occurence of myelodysplastic syndromes or leukaemia. Patients under high-dose chemotherapy. Transient thromboyctopenia following therapy & leukapheresis. Anticoagulated or known defects in haemostasis. Severe chronic neutropenia w/ abnormal cytogenetics. Causes of transient neutropenia eg, viral infections. Splenic enlargement. Autoimmune neutropenia. Known bone marrow infiltrating infections or malignancy. Sickle cell disease. Hereditary fructose intolerance. May affect ability to drive & use machines. Pregnancy. Not recommended in lactation. Neonates.
Adverse Reactions
Elevated alkaline phosphatase, LDH, uric acid, decreased glucose, hyperuricemia; nausea/vomiting; elevated GGT; Chest & musculoskeletal pain; leukocytosis, thrombocytopenia; anaemia, splenomegaly, hepatomegaly. Headache, constipation, anorexia, diarrhoea, mucositis; alopecia, skin rash, cutaneous vasculitis, inj site pain; fatigue, generalised weakness; osteoporosis; spleen disorder.
Drug Interactions
May cause severe thrombocytopenia w/ concomitant use of single or combined chemotherapeutic agents. Exacerbated severe neutropenia w/ 5-fluorouracil. Potentiated effect by lithium.
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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