Zarzio

Reduction in the duration of neutropenia & incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (except chronic myeloid leukaemia & 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. Mobilisation of peripheral blood progenitor cells (PBPCs). Increase in neutrophil counts & reduction in the incidence & duration of infection-related events in long term administration in adults or childn w/ severe congenital, cyclic, or idiopathic neutropenia w/ ANC ≤0.5 x 10⁹/L, & history of severe or recurrent infections. Persistent neutropenia (ANC ≤1 x 10⁹/L) in patients w/ advanced HIV infection.

Established cytotoxic chemotherapy 0.5 MU (5 mcg)/kg daily as SC inj or IV infusion over 30 min. 1st dose should be administered at least 24 hr after cytotoxic chemotherapy. Myeloablative therapy followed by bone marrow transplantation Initially 1 MU (10 mcg)/kg daily as 30-min or 24-hr IV infusion or as continuous 24-hr SC infusion. 1st dose should be administered at least 24 hr following cytotoxic chemotherapy & at least 24 hr after bone marrow infusion. PBCP mobilisation in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation 1 MU (10 mcg)/kg daily as 24-hr SC continuous infusion or SC inj for 5-7 consecutive days. PBPC mobilisation after myelosuppressive chemotherapy 0.5 MU (5 mcg)/kg daily as SC inj from the 1st day after completion of chemotherapy until the expected neutrophil nadir is passed & neutrophil count has recovered to normal range. PBPC mobilisation in normal donors prior to allogeneic PBPC transplantation 1 MU (10 mcg)/kg daily as SC inj for 4-5 consecutive days. Congenital neutropenia Initially 1.2 MU (12 mcg)/kg daily by SC inj as single dose or in divided doses. Idiopathic or cyclic neutropenia Initially 0.5 MU (5 mcg)/kg daily by SC inj as single dose or in divided doses. Reversal of neutropenia in patient w/ HIV infection Initially 0.1 MU (1 mcg)/kg daily by SC inj w/ titration up to max of 0.4 MU (4 mcg)/kg daily until a normal neutrophil count is reached & can be maintained. Maintenance of normal neutrophil counts Initial dose adjustment to alternate day dosing w/ 30 MU (300 mcg) daily by SC inj.

Hypersensitivity.

Discontinue use in patients w/ clinically significant hypersensitivity; in case of acute resp distress syndrome. Not to be administered in patients w/ history of hypersensitivity to filgrastim or pegfilgrastim; severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution. Not to be used to increase cytotoxic chemotherapy dose beyond established dosage regimens. Not indicated for use in myelodysplastic syndrome or chronic myelogenous leukaemia. Glomerulonephritis; capillary leak syndrome; splenomegaly & splenic rupture; malignant cell growth; immunogenicity; vascular disorders, including veno-occlusive disease & fluid vol disturbances, in patients undergoing high-dose chemotherapy followed by transplantation; Graft versus Host disease (GvHD) & fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation; transient abnormal bone scans. Neutrophil response may be diminished in patients w/ reduced myeloid progenitors. Patients w/ secondary acute myelogenous leukaemia; sickle cell trait or disease; high-dose chemotherapy. Monitor platelet counts especially during the 1st few wk of therapy; bone density in patients w/ underlying osteoporotic bone diseases who undergo continuous therapy for >6 mth; haematocrit. Regularly perform WBC count during therapy. May have minor influence on ability to drive & use machines. Not recommended during pregnancy. Lactation. De novo administration in AML patients <55 yr w/ good cytogenetics [t(8;21), t(15;17), & inv(16)]. Patients undergoing PBPC mobilisation: Recommended min yield or acceleration of platelet recovery to the same degree may not be achieved in patients who have undergone very extensive prior myelosuppressive therapy. Progenitor yield may be reduced in patients treated w/ some cytotoxic agents (eg, melphalan, carmustine, & carboplatin) when administered over prolonged periods prior to attempts at mobilisation. Normal donors undergoing PBPC mobilisation: Should only be considered for purposes of allogeneic stem cell transplantation. Normal donors <16 yr or >60 yr. Do not perform leukapheresis if platelets <75 x 10⁹/L & in donors who are anticoagulated or who have known haemostasis defects. Monitor donors receiving G-CSFs for PBPC mobilisation until haematological indices return to normal. Perform systematic record & tracking of stem-cell donors for at least 10 yr to ensure monitoring of long-term safety. Recipients of allogeneic PBPCs mobilised w/ filgrastim: May be associated w/ increased risk of acute & chronic GvHD. SCN patients: Perform CBC w/ differential & platelet counts, & evaluate bone marrow morphology & karyotype prior to treatment; morphologic & cytogenetic bone marrow exam at regular intervals (approx every 12 mth); urinalysis regularly. Exclude cases of transient neutropenia eg, viral infections. Patients, including neonates, w/ autoimmune neutropenia. Patients w/ HIV infection: Closely monitor ANC especially during the 1st few wk of therapy. Regularly monitor blood counts. Infections & malignancies causing myelosuppression.

Thrombocytopenia, anaemia; headache; diarrhoea, vomiting, nausea; alopecia; musculoskeletal pain; fatigue, mucosal inflammation, pyrexia. Sepsis, bronchitis, URTI, 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.

Not recommended to be used in the period from 24 hr before to 24 hr after chemotherapy. May exacerbate severity of neutropenia w/ 5-fluorouracil. Effect may be potentiated w/ lithium.

Haematopoietic Agents / Supportive Care Therapy

L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.

Rx