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Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting
Date:5/29/2009

leukemic blasts in bone marrow or peripheral blood (10 percent), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy. Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious or anaphylactic reactions occur, Leukine therapy should immediately be discontinued and appropriate therapy initiated. Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates or CHF; respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, pleural and or/pericardial effusion, supraventricular tachycardia, sequestration of granulocytes in the pulmonary circulation and dyspnea have been reported in patients after Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration. Adverse events occurring in 10 percent of AML patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, and anorexia. If ANC 20,000 cells/mm3 or if platelet counts 500,000 mm3, Leukine administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed. Leukine therapy should be discontinued if disease progression is detected during treatment.

For more information about Leukine, including full prescribing information, visit www.leukine.com.

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