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These highlights do not include all the information needed to use ADRIAMYCIN (DOXOrubicin HCl) safely and effectively. See full prescribing information for ADRIAMYCIN (Doxorubicin HCl). ADRIAMYCIN (DOXOrubicin HCl) Injection, USP, for intravenous use Initial U.S. Approval: 1974
Medication labelWhy this: Advisory · dailymed-prescription
Cardiomyopathy: Myocardial damage, including acute left ventricular failure can occur with doxorubicin. The risk of cardiomyopathy is proportional to the cumulative exposure with incidences from 1% to 20% for cumulative doses from 300 mg/m2 to 500 mg/m2 when doxorubicin is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess LVEF before and regularly during and after treatment with doxorubicin [see Warnings and Precautions (5.1)]. Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin [see Warnings and Precautions (5.2)]. Extravasation and Tissue Necrosis: Extravasation of doxorubicin can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting.Immediately terminate the drug, and apply ice to the affected area [see Warnings and Precautions (5.3)]. Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4)]. Adriamycin (DOXOrubicin HCl) Injection, USP and Adriamycin (DOXOrubicin HCl) for Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14.1)]. Doxorubicin is indicated for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia Hodgkin lymphoma non-Hodgkin lymphoma (NHL) metastatic breast cancer metastatic Wilms’ tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcoma metastatic ovarian carcinoma
- generic_name
- doxorubicin hydrochloride
- product_names
- Doxorubicin Hydrochloride
- ndc
- 0143-9369, 0143-9369-01, 0143-9370, 0143-9370-01, 0143-9371, 0143-9371-01, 0143-9372, 0143-9372-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en