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WARNINGS

Mylotarg (gemtuzumab ozogamicin for injection) 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.

There are no controlled trials demonstrating efficacy and safety using Mylotarg (gemtuzumab ozogamicin for injection) in combination with other chemotherapeutic agents. Therefore, Mylotarg (gemtuzumab ozogamicin for injection) should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials.

Severe myelosuppression occurs when Mylotarg (gemtuzumab ozogamicin for injection) is used at recommended doses.

HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS, PULMONARY EVENTS

Mylotarg (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) and resolved. Mylotarg (gemtuzumab ozogamicin for injection) 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/µL prior to administration of Mylotarg. (See WARNINGS.)

HEPATOTOXICITY

Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported in association with the use of Mylotarg (gemtuzumab ozogamicin for injection) 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). Patients who receive Mylotarg (gemtuzumab ozogamicin for injection) either before or after HSCT, patients with underlying hepatic disease or abnormal liver function, and patients receiving Mylotarg (gemtuzumab ozogamicin for injection) in combinations with other chemotherapy are at increased risk for developing VOD, including severe VOD. Death from liver failure and from VOD has been reported in patients who received Mylotarg (gemtuzumab ozogamicin for injection) . Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD. These symptoms can include: rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations in bilirubin and/or liver enzymes. However, careful monitoring may not identify all patients at risk or prevent the complications of hepatotoxicity. (See WARNINGS and ADVERSE REACTIONS sections.)