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Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
Date:6/2/2008

bone marrow function, which is usually reversible and dose dependent, should be anticipated and is likely to increase the risk of infection, including severe sepsis. Administration of Clolar results in a rapid reduction of peripheral leukemia cells. Patients should be evaluated and monitored for signs and symptoms of tumor lysis syndrome and cytokine release (e.g., tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome (SIRS)/capillary leak syndrome, and organ dysfunction. Clolar should be discontinued immediately in the event of clinically significant signs or symptoms of SIRS or capillary leak syndrome.

The most common side effects seen after Clolar treatment, regardless of causality, were gastrointestinal tract symptoms, including vomiting, nausea, and diarrhea; hematologic effects including anemia, leukopenia, thrombocytopenia, neutropenia, and febrile neutropenia; and infection.

Liver and kidney function should be assessed prior to and during treatment with Clolar, as the liver is a target organ for Clolar toxicity and Clolar is excreted primarily through the kidneys. Concomitant use of medications known to induce hepatic toxicity should be avoided. Cardiac disorders, including tachycardia, pericardial effusion, and left ventricular systolic dysfunction, have been noted in up to 35% of pediatric patients treated with Clolar. However, the presence of these disorders in patients prior to Clolar administration and/or previous therapy or concurrent illness in patients receiving Clolar makes the etiology of these disorders unclear.

Clolar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant and avoid breast feeding while receiving treatment with Clolar.

For more information about Clolar, please call 1-800-RX CLOLAR or visit http://www.CLOLAR.com
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SOURCE Genzyme Corp.
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