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HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS, PULMONARY EVENTS

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Abstract

(gemtuzumab ozogamicin for Injection) for intravenous use only WARNINGS Mylotarg should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients. Controlled trials have failed to demonstrate efficacy and safety using Mylotarg in combination with other chemotherapeutic agents (see CLINICAL STUDIES section). Therefore, Mylotarg should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when Mylotarg is used at recommended doses

Year: 2010
OAI identifier: oai:CiteSeerX.psu:10.1.1.173.4280
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