VIAL (lyophilized powder): 1 x 20 ml x 5 mg.
Do not administer as an I.V. push or bolus.
The recommended dose is 9 mg/m2
, infused over a 2-hour period. Physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white blood count to below 30,000/mcl prior to administration. Appropriate measures (e.g. hydration and allopurinol) must be taken to prevent hyperuricemia. Patients should receive the following prophylactic medications one hour before administration: Diphenhydramine 50 mg po and acetaminophen 650-1,000 mg po; thereafter, two additional doses of acetaminophen 650-1,000 mg po, one every 4 hours as needed. Vital signs should be monitored during infusion and for four hours following infusion. The recommended treatment course is a total of 2 doses with 14 days between the doses. Full recovery from hematologic toxicities is not a requirement for administration of the second dose.
Treatment of patients with CD3
3 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. The safety and efficacy of Mylotarg in patients with poor performance status and organ dysfunction has not been established.
Known hypersensitivity to gemtuzumab ozogamicin or any of its components: anti-CD3
3 antibody (hP67.6), calicheamicin derivatives, or inactive ingredients.
Do not administer as I.V. push or bolus. 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. Administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of treatment should be strongly considered for patients who develop anaphylaxis, pulmonary edema, or acute respiratory distress syndrome. Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported in association when used 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 either before or after HSCT, patients with underlying hepatic disease or abnormal liver function, and patients receiving Mylotarg in combinations with other chemotherapy are at increased risk for developing VOD. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD. Severe myelosuppression will occur in all patients given the recommended dose of this agent. Careful hematologic monitoring is required. Systemic infections should be treated. Can produce a post-infusion symptom complex of fever and chills, and less commonly hypotension and dyspnea that may occur during the first 24 hours after administration. In clinical trials, most patients received the following prophylactic medications before administration: diphenhydramine 50 mg po and acetaminophen 650 1000 mg po; thereafter, two additional doses of acetaminophen 650 1000 mg po, one every 4 hours as needed. Vital signs should be monitored during infusion and for the four hours following infusion. Pulmonary signs, symptoms and clinical findings, include dyspnea, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, and acute respiratory distress syndrome. Patients with WBC counts > 30,000/mcl may be at increased risk. Physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/mcl prior to administration. Patients with symptomatic intrinsic lung disease may also be at greater risk of severe pulmonary reactions.Tumor Lysis Syndrome: Physicians should consider reducing the peripheral white blood count to <30,000 mcL prior to administration.
Pregnancy and lactation
: If used in pregnancy, or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment.
Fever, nausea, chills, vomiting, headache, dyspnea, hypotension, hypertension, hyperglycemia, hypoxia. Fever and chills were commonly reported despite prophylactic treatment with acetaminophen and antihistamines. Generally, these symptoms occurred at the end of the 2 hour infusion and resolved after 2 to 4 hours with supportive therapy including acetaminophen, diphenhydramine, and intravenous fluids.
No formal studies have been conducted.