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There is no known antidote for overdoses of ELLENCE. A 36-year-old man with non-Hodgkin's lymphoma received a daily 95 mg/m² dose of ELLENCE Injection for 5 consecutive days. Five days later, he developed bone marrow aplasia, grade 4 mucositis, and gastrointestinal bleeding. No signs of acute cardiac toxicity were observed. He was treated with antibiotics, colony-stimulating factors, and antifungal agents, and recovered completely. A 63-year-old woman with breast cancer and liver metastasis received a single 320 mg/m² dose of ELLENCE. She was hospitalized with hyperthermia and developed multiple organ failure (respiratory and renal), with lactic acidosis, increased lactate dehydrogenase, and anuria. Death occurred within 24 hours after administration of ELLENCE. Additional instances of administration of doses higher than recommended have been reported at doses ranging from 150 to 250 mg/m² . The observed adverse events in these patients were qualitatively similar to known toxicities of epirubicin. Most of the patients recovered with appropriate supportive care.
If an overdose occurs, provide supportive treatment (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) until the recovery of toxicities. Delayed CHF has been observed months after anthracycline administration. Observe patients carefully over time for signs of CHF and provided with appropriate supportive therapy.
Patients should not be treated with ELLENCE Injection if they have any of the following conditions:
Cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see WARNINGS AND PRECAUTIONS] Previous treatment with maximum cumulative dose of anthracyclines [see WARNINGS AND PRECAUTIONS].
Hypersensitivity to ELLENCE, other anthracyclines, or anthracenediones [see ADVERSE REACTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/30/2014
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