Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment. Permanently discontinue in patients w/ clinically significant hypersensitivity. Caution in patients w/ AML. Do not use in patients w/ myelodysplastic syndrome, chronic myelogenous leukaemia, & secondary AML. Do not use to increase dose of cytotoxic chemotherapy beyond established dosage regimens. Reports of pulmonary adverse reactions, in particular interstitial pneumonia; glomerulonephritis; capillary leak syndrome; splenomegaly & splenic rupture; aortitis. Regular monitoring of platelet count & haematocrit is recommended. Take special care when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia. Caution in patients w/ sickle cell trait or sickle cell disease. Perform WBC count at regular intervals during therapy. Discontinue immediately if leukocyte counts >50 x 10
9/L after expected nadir. Do not restart treatment in patients who developed SJS. Potential for immunogenicity. Transient +ve bone-imaging findings. Contains sorbitol. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Paed population.
De novo AML patients <55 yr w/ cytogenetics t(15;17). Patients receiving high dose chemotherapy.