IDT Biologika


Concise Prescribing Info
Reduction in the duration of neutropenia & in the 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. Mobilisation of peripheral blood progenitor cells (PBPCs). Increase neutrophil counts & reduce incidence & duration of infection-related events in adult or childn w/ severe congenital, cyclic or idiopathic neutropenia & history of severe or recurrent infections. Treatment of persistent neutropenia in patients w/ advanced HIV infection.
Dosage/Direction for Use
SC Established cytotoxic chemotherapy 5 mcg/kg/day. 1st dose should be administered at least 24 hr after cytotoxic chemotherapy. Patient treated w/ myeloablative therapy followed by bone marrow transplantation 10 mcg/kg/day. 1st dose should be administered at least 24 hr following cytotoxic chemotherapy & at least 24 hr after bone marrow infusion. Mobilisation of PBPCs in patient undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation 10 mcg/kg/day for 5-7 consecutive days. Timing of leukapheresis: 1 or 2 on days 5 & 6. Maintain dosing until the last leukapheresis. PBPC mobilisation after myelosuppressive chemotherapy 5 mcg/kg/day from the 1st day after completion of chemotherapy until the expected neutrophil nadir is passed & neutrophil count has recovered to normal range. Mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation 10 mcg/kg/day for 4-5 consecutive days. Start leukapheresis at day 5 & continued until day 6 if needed. Congenital neutropenia Starting dose: 12 mcg/kg/day as single dose or divided doses. Idiopathic or cyclic neutropenia Starting dose: 5 mcg/kg/day as single dose or divided doses. Reversal of neutropenia in patient w/ HIV infection Starting dose: 1 mcg/kg/day w/ titration up to max of 4 mcg/kg/day until a normal neutrophil count is reached & can be maintained. Maintenance of normal neutrophil counts Initial dose adjustment to alternate day dosing: 300 mcg/day.
Special Precautions
Hypersensitivity including anaphylactic reactions. Patients w/ recent history of lung infiltrates or pneumonia. Discontinue if acute resp distress syndrome occurs. Glomerulonephritis. Capillary leak syndrome; monitor patients who develop symptoms of capillary leak syndrome. Diagnosis of splenic rupture should be considered in donors &/or patients reporting left upper abdominal or shoulder tip pain. Malignant cell growth. Not indicated for myelodysplastic syndrome or chronic myelogenous leukaemia. Patients w/ secondary acute myelogenous leukaemia, de novo AML patients <55 yr w/ good cytogenetics, sickle cell trait or disease, osteoporosis, cancer patients. Discontinue if leukocyte count is >50 x 109/L. Immunogenicity. High-dose chemotherapy. Patients & normal donors undergoing PBPC mobilisation, recipients of allogeneic PBPCs mobilised w/ filgrastim. Should not be administered to patients w/ severe congenital neutropenia who develop leukemic evolution. Autoimmune neutropenia. HIV. Infections & malignancies causing myelosuppression. Monitor urinalysis, platelet counts (especially during the 1st wk), hematocrit. Perform WBC count at regular intervals during therapy. Evaluate bone marrow morphology & karyotype prior to treatment. Should not be administered 24 hr before or after a myelosuppressive cytotoxic chemotherapy. May have minor influence on the ability to drive & use machines. Pregnancy & lactation. Neonates.
Adverse Reactions
Thrombocytopenia, anemia; headache; diarrhea, vomiting, nausea; alopecia; musculoskeletal pain; fatigue, mucosal inflammation, pyrexia. Sepsis, bronchitis, upper resp tract infection, UTI; splenomegaly, decreased Hg; decreased appetite, increased blood lactate dehydrogenase; insomnia; dizziness, hypoaesthesia, paraesthesia; HTN, hypotension; hemoptysis, dyspnea, cough, oropharyngeal pain, epistaxis; oral pain, constipation; hepatomegaly, increased blood alkaline phosphatase; rash, erythema; muscle spasms; dysuria, hematuria; chest pain, pain, asthenia, malaise, peripheral edema; transfusion reaction.
Drug Interactions
May exacerbate severity of neutropenia w/ 5-fluorouracil. Potentiation w/ lithium. 
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Zarzio soln for inj 30 Million unit per 0.5 mL
(w/ inj needle (stainless steel), needle safety guard) 0.5 mL x 5 × 1's
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