Permanently discontinue in patients w/ clinically significant hypersensitivity. Do not administer in patients w/ history of hypersensitivity to pegfilgrastim or filgrastim. Long-term effects in acute myeloid leukaemia (AML).
De novo AML patients <55 yr w/ cytogenetics t(15;17). Do not use in patients w/ myelodysplastic syndrome (MDS), chronic myelogenous leukaemia, & in patients w/ secondary AML. Do not use to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Higher risk of pulmonary adverse events particularly interstitial pneumonia in patients w/ recent history of pulmonary infiltrates or pneumonia. Discontinue in case of preliminary signs of acute resp distress syndrome. Glomerulonephritis. Closely monitor patients who develop symptoms of capillary leak syndrome. Carefully monitor spleen size (eg, clinical exam, ultrasound) & consider diagnosis of splenic rupture in patients w/ left upper abdominal pain or shoulder tip pain. Regularly monitor platelet count & haematocrit. Monitor for signs & symptoms of MDS/AML in patients w/ breast & lung cancer. Patients w/ sickle cell trait or disease. Perform WBC count at regular intervals during therapy & discontinue immediately if leukocyte counts >50 x 10
9/L. Do not restart treatment if SJS develops. Potential for immunogenicity. Aortitis. Mobilisation of blood progenitor cells in patients or healthy donors. Latex sensitivity. Increased haematopoietic bone marrow activity associated w/ transient +ve bone-imaging findings. Contains sorbitol. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn.