The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

Doxorubicin Hydrochloride Injection/for Injection is an anthracycline topoisomerase inhibitor indicated: •as a component of multiagent adjuvant chemotherapy for the treatment of women with axillary lymph node involvement following resection of primary breast cancer. •for the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma.

•Single agent: 60 to 75 mg/m2 given intravenously every 21 days. •In combination: 40 to 75 mg/m2 given intravenously every 21 to 28 days. •Discontinue Doxorubicin Hydrochloride Injection/for Injection in patients who develop signs or symptoms of cardiomyopathy. •Reduce dose in patients with hepatic impairment.

The most common (>10%) adverse reactions are alopecia, nausea and vomiting.

•Severe myocardial insufficiency. •Recent myocardial infarction. •Severe persistent drug-induced myelosuppression. •Severe hepatic impairment. •Severe hypersensitivity to doxorubicin hydrochloride.

•Radiation-Induced Toxicity: Can be increased by the administration of Doxorubicin Hydrochloride Injection/for Injection. Radiation recall can occur in patients who receive Doxorubicin Hydrochloride Injection/for Injection after prior radiation therapy. •Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms.