Neupogen

Neupogen

filgrastim

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va 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/ the 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. Mobilisation of peripheral blood progenitor cells (PBPCs). 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 when other options to manage neutropenia are inappropriate.
Dosage/Direction for Use
Established cytotoxic chemotherapy 0.5 MU (5 mcg)/kg/day as SC inj or IV infusion over 30 min. Administer 1st dose at least 24 hr after cytotoxic chemotherapy. In myeloablative therapy followed by bone marrow transplantation Initially, 1 MU (10 mcg)/kg/day as 30-min or 24-hr IV infusion or by continuous 24-hr SC infusion. Administer 1st dose at least 24 hr following cytotoxic chemotherapy & at least 24 hr after bone marrow infusion. PBPC mobilisation when used alone 1 MU (10 mcg)/kg/day 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/day as SC inj from 1st day after completion of chemotherapy until expected neutrophil nadir is passed & neutrophil count normalizes. PBPC mobilisation in normal donors prior to allogeneic PBPC transplantation 1 MU (10 mcg)/kg/day as SC inj for 4-5 consecutive days. Congenital neutropenia Initially, 1.2 MU (12 mcg)/kg/day SC as a single dose or in divided doses. Idiopathic or cyclic neutropenia Initially, 0.5 MU (5 mcg)/kg/day SC as a single dose or in divided doses. Patients w/ HIV infection Reversal of neutropenia Initially, 0.1 MU (1 mcg)/kg/day SC w/ titration up to max of 0.4 MU (4 mcg)/kg/day until normal neutrophil count is reached & maintained (ANC >2 x 109/L). Doses up to 1 MU (10 mcg)/kg/day were required in small number of patients (<10%). Maintaining normal neutrophil counts Alternate-day dosing w/ 30 MU (300 mcg)/day SC.
Contraindications
Special Precautions
Hypersensitivity occurring on initial or subsequent treatment. Reports of pulmonary adverse effects, particularly interstitial lung disease; glomerulonephritis; capillary leak syndrome; splenomegaly & splenic rupture; malignant cell growth; thrombocytopenia; aortitis. Not indicated for use in myelodysplastic syndrome, or chronic myelogenous leukaemia. Patients w/ secondary AML; de novo AML patients <55 yr w/ good cytogenetics (t(8;21), t(15;17), & inv(16)); patients w/ sickle cell trait or sickle cell disease. Potential risks associated w/ severe leukocytosis. Perform WBC count at regular intervals during therapy. Discontinue if leukocyte counts exceed 50 x 109/L after expected nadir. Discontinue or reduce dose if leukocyte counts rise to >70 x 109/L during period of administration for PBPC mobilisation. Potential for immunogenicity. Monitor bone density in patients w/ underlying osteoporotic bone diseases who undergo continuous Neupogen therapy for >6 mth. Rare hereditary problems of fructose intolerance. Minor influence on the ability to drive & use machines. Pregnancy & lactation. Cancer patients: Do not use to increase dose of cytotoxic chemotherapy beyond established dosage regimens. Special caution when treating patients w/ high-dose chemotherapy. Regularly monitor platelet count & haematocrit. Patients w/ substantially reduced myeloid progenitors. Reports of vascular disorders; GvHD & fatalities in patients receiving G-CSF after allogeneic bone marrow transplant; transient abnormal bone scans. Patients undergoing PBPC mobilisation: Patients who have undergone very extensive myelosuppressive therapy. Normal donors undergoing PBPC mobilisation: Should only be considered for the purposes of allogeneic stem cell transplantation. Transient thrombocytopenia following filgrastim administration & leukapheresis. Transient cytogenetic abnormalities. Monitor donors until haematological indices return to normal. Normal donors <16 yr or >60 yr. Increased risk of acute & chronic GvHD when compared w/ bone marrow transplantation. Severe chronic neutropenia (SCN) patients: Should not be administered in SCN patients who develop leukaemia or have evidence of leukaemic evolution. Closely monitor blood cell counts. Perform complete blood cell counts w/ differential & platelet counts, & an evaluation of bone marrow morphology & karyotype prior to treatment. Perform morphologic & cytogenetic bone marrow exam in patients at regular intervals. Cases of transient neutropenia eg, viral infections should be excluded. Perform regular urinalysis. Neonates & patients w/ autoimmune neutropenia. Patients w/ HIV infection: Closely monitor absolute neutrophil count (ANC) especially during the 1st few wk of therapy. Perform regular monitoring of blood counts. Patients w/ known bone marrow infiltrating infections or malignancy.
Adverse Reactions
Thrombocytopenia, anaemia; headache; diarrhoea, vomiting, nausea; alopecia; musculoskeletal pain; fatigue, mucosal inflammation, pyrexia. Sepsis, bronchitis, upper resp tract infection, UTI; splenomegaly; Hb decreased; decreased appetite, blood lactate dehydrogenase increased; insomnia; dizziness, hypoaesthesia, paraesthesia; HTN, hypotension; haemoptysis, dyspnoea, cough, oropharyngeal pain, epistaxis; oral pain, constipation; hepatomegaly, blood alkaline phosphatase increased; rash, erythema; muscle spasms; dysuria, haematuria; chest pain, pain, asthenia, malaise, oedema peripheral; transfusion reaction.
Drug Interactions
Exacerbated neutropenia w/ 5-fluorouracil. Use of Neupogen is not recommended in the period from 24 hr before or 24 hr after chemotherapy w/ myelosuppressive cytotoxic agents.
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Presentation/Packing
Form
Neupogen inj (vial) 0.3 mg/mL
Packing/Price
4 × 1's
Form
Neupogen pre-filled inj 0.3 mg/0.5 mL
Packing/Price
1's
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