Severe local tissue necrosis will occur if there is extravasation during administration. Doxorubicin must not be given by the IM or SC route (see Dosage & Administration).
Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure (CHF) may occur either during therapy or months to years after termination of therapy. Cardiac toxicity may occur at lower cumulative doses whether or not cardiac risk factors are present. Children are at increased risk for developing delayed cardiotoxicity.
Secondary acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS), with or without a preleukemic phase, has been reported in patients treated with athracyclines, including doxorubicin. The occurrence of refractory secondary AML or MDS is more common when anthracyclines are given in combination with DNA-damaging antineoplastic agents or radiotherapy, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. Secondary leukemia can have a 1- to 3-year latency period, and can occur as late as 10 years following treatment. Children are also at risk of developing secondary AML.
Dosage should be reduced in patients with impaired hepatic function.
Severe myelosuppression may occur.
Doxorubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
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