Zarzio

Zarzio

filgrastim

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Firma Vai Hong
Concise Prescribing Info
Contents
Filgrastim
Indications/Uses
Reduction in duration of neutropenia & incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (w/ exception of 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 (PBPC). Increase neutrophil counts & reduce incidence and duration of infection-related events in adults & childn w/ severe congenital, cyclic or idiopathic neutropenia w/ an absolute neutrophil count (ANC) of ≤0.5 x 109/L & history of severe or recurrent infections. Treatment of persistent neutropenia (ANC ≤1 x 109/L) in patients w/ advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Dosage/Direction for Use
Cytotoxic chemotherapy 0.5 MU/kg/day SC inj or IV infusion over 30 min. 1st dose to be administered not <24 hr following cytotoxic chemotherapy. Patient treated w/ myeloablative therapy followed by bone marrow transplantation 1 MU/kg/day IV short-term infusion over 30 min or SC or IV continuous infusion over 24 hr. 1st dose to be administered not <24 hr following cytotoxic chemotherapy & w/in 24 hr of bone marrow infusion. Mobilisation of PBPC Patient undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation 1 MU/kg/day continuous SC infusion over 24 hr for 5-7 consecutive days. After myelosuppressive therapy, 0.5 MU/kg/day from the 1st day after completion of chemotherapy until neutrophil count has recovered to normal range. Normal donors prior to allogeneic PBPC transplantation 1 MU/kg/day continuous SC infusion over 24 hr for 4-5 consecutive days. Chronic congenital neutropenia 1.2 MU/kg/day SC inj as single or in divided doses until neutrophil count reaches >1.5 x 109/L then minimal effective dose. Chronic idiopathic or cyclic neutropenia 0.5 MU/kg/day SC inj as single or in divided doses until neutrophil count reaches >1.5 x 109/L. Reversal of neutropenia in HIV patients 0.1 MU/kg/day SC inj daily w/ titration up to max of 0.4 MU/kg/day until neutrophil count is maintained at >2 x 109/L. Maintenance: 30 MU/day.
Contraindications
Special Precautions
Do not use to increase the dose of cytotoxic chemotherapy beyond established posology regimens. Severe congenital neutropenia. Malignant cell growth. Patients w/ myelodysplastic syndrome, chronic myelogenous leukaemia, secondary AML. Discontinue or reduce dose if leukocyte counts rise to >70 x 109/L. Risks associated w/ increased doses of chemotherapy including cardiac, pulmonary, neurologic & dermatologic effects. Regular monitoring of platelet count & haematocrit. Patients undergoing high-dose chemotherapy. Consider transient abnormal bone scans associated w/ growth factor therapy when interpreting bone-imaging results. Prior exposure to cytotoxic agents. Pay attention to method of quantitation in the assessment of progenitor cell yields. Immunological interactions associated w/ increased risk of acute & chronic GvHD. Closely monitor platelet counts & ANC. Perform CBC, regular urine analyses & evaluate bone marrow morphology & karyotype prior to treatment. Exclude causes of transient neutropenia. Evaluate spleen size regularly. Risk associated w/ increased doses of myelosuppressive medicinal products. Infections and malignancies causing myelosuppression. Patients w/ history of pulmonary infiltrates or pneumonia; sickle cell disease. Monitor bone density in patients w/ underlying osteoporotic bone diseases. Capillary leak syndrome. Rare hereditary problems of fructose intolerance. Pregnancy & lactation.
Adverse Reactions
Drug hypersensitivity; increased blood uric acid, increased blood lactate dehydrogenase, decreased appetite; headache; hypotension; oropharyngeal pain, cough, dyspnoea, haemoptysis; diarrhoea, vomiting, constipation, nausea; increased γ-glutamyl trasnferase, increased blood aklaline phosphatase; rash, alopecia; musculoskeletal pain, dysuria; asthenia, fatigue, mucosal inflammation; chest pain. Leucocytosis, thrombocytopenia, splenomegaly, anaemia; hyperuricemia, decreased blood glucose; epistaxis; hepatomegaly; cutaneous vasculitis; arthralgia, osteoporosis; haematuria, inj site reaction.
Drug Interactions
May exacerbate severity of neutropenia w/ 5-FU. Increased effect w/ lithium.
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Presentation/Packing
Form
Zarzio soln for inj or infusion 30 Million unit/0.5 mL
Packing/Price
5 × 1's
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