Neupogen

Filgrastim

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 duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. Peripheral blood progenitor cells (PBPCs) mobilisation. Long-term administration to increase neutrophil counts & reduce incidence & duration of infection-related events in childn or adults 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 to reduce risk of bacterial infections, when other options to manage neutropenia are inappropriate. Patients w/ AML. Reduce duration of neutropenia & related clinical sequelae in patients undergoing induction or consolidation chemotherapy.

Established cytotoxic chemotherapy 0.5 MU (5 mcg)/kg daily as SC inj or IV infusion over 30 min. Administer 1st dose 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 continuous 24 hr SC infusion. Administer 1st dose at least 24 hr after cytotoxic chemotherapy & at least 24 hr after bone marrow infusion. PBPC mobilization when used alone 1 MU (10 mcg)/kg daily as 24-hr SC continuous infusion or single daily SC inj for 5-7 consecutive days. PBPC mobilisation after myelosuppressive chemotherapy 0.5 MU (5 mcg)/kg daily as SC inj from 1st day after completion of chemotherapy. PBPC mobilisation in normal donors prior to allogeneic PBPC transplantation 1 MU (10 mcg)/kg daily SC for 4-5 consecutive days. Congenital neutropenia Initially 1.2 MU (12 mcg)/kg daily SC as single dose or in divided doses. Idiopathic or cyclic neutropenia Initially 0.5 MU (5 mcg)/kg daily SC as single dose or in divided doses. Patients w/ HIV infection Reversal of neutropenia Initially 0.1 MU (1 mcg)/kg daily given as SC inj, w/ titration up to max of 0.4 MU (4 mcg)/kg daily until normal neutrophil count is reached & can be maintained (ANC >2 x 10⁹/L). Maintaining normal neutrophil counts Alternate-day dosing w/ 30 MU (300 mcg) daily by SC inj.

Hypersensitivity.

Permanently discontinue if hypersensitivity occur. Do not administer in patients w/ history of hypersensitivity to filgrastim or pegfilgrastim. Patients w/ recent history of lung infiltrates or pneumonia. Discontinue therapy if preliminary signs of acute resp distress syndrome (ARDS) occur. Urinalysis monitoring for glomerulonephritis. Closely monitor patients who develop capillary leak syndrome. Carefully monitor spleen size for splenomegaly & spleen rupture. Malignant cell growth. Myelodysplastic syndrome or chronic myelogenous leukaemia. De novo AML (<55 yr w/ good cytogenetics). Closely monitor platelet counts & ANC especially during 1st few wk of therapy; severe chronic neutropenia who develop thrombocytopenia. Perform WBC count at regular intervals during therapy; discontinue use if leukocyte counts >50 x 10⁹/L. Potential for immunogenicity. Aortitis. Sickle cell trait or sickle cell disease. Monitor bone density in patients w/ underlying osteoporotic bone diseases who undergo continuous therapy >6 mth; sign & symptoms of MDS/AML in patient w/ breast & lung cancer. Do not use to increase cytotoxic chemotherapy dose beyond dosage regimens. High-dose chemotherapy. Regularly monitor hematocrit; caution in administering single or combination chemotherapeutic agents known to cause severe thrombocytopenia. Patients w/ substantially reduced myeloid progenitors. Vascular disorders; GvHD; transient abnormal bone scans. Patients who have undergone very extensive prior myelosuppressive therapy. Normal donors <16 or >60 yr. Do not administer in patients w/ severe congenital neutropenia who develop leukaemia. Perform CBC counts w/ differential & platelet counts, & bone marrow morphology & karyotype evaluation prior to treatment. Neonates & patients w/ autoimmune neutropenia. Infections & malignancies causing myelosuppression. Fructose intolerance. Minor influence on the ability to drive & use machines. Not recommended during pregnancy. Lactation.

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.

Severity of neutropenia may be exacerbated w/ 5-fluorouracil.

Haematopoietic Agents / Supportive Care Therapy

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

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