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Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®
Date:6/21/2010

apeutic agents. Therefore, Mylotarg should only be used as a single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials.  Severe myelosuppression occurs when Mylotarg is used at recommended doses.

Mylotarg administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events have been fatal.  In most cases, infusion-related symptoms occurred during the infusion or within 24 hours of administration of Mylotarg and resolved.

Mylotarg infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.  Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Mylotarg (gemtuzumab ozogamicin for Injection) treatment should be strongly considered for patients who develop anaphylaxis, pulmonary edema, or acute respiratory distress syndrome.  Since patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome, physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000 per microliter prior to administration of Mylotarg.

Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported in association with the use of Mylotarg as a single agent, as part of a combination chemotherapy regimen, and in patients without a history of liver disease or hematopoietic stem-cell transplant (HSCT).  (See WARNINGS and ADVERSE REACTIONS sections of the full Information.) Patients who receive Mylotarg either before or after HSCT, patients with underlying hepatic disease or abnormal liver function, and patients receiving Mylotarg in combinations with other chemotherapy
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