Doxorubicin Hydrochloride Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling.

• Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1) ] • Secondary Malignancies [see Warnings and Precautions (5.2) ] • Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3) ] • Severe Myelosuppression [see Warnings and Precautions (5.4) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] • Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.7) ] The most common (>10%) adverse reactions are alopecia, nausea and vomiting.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc.

at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Breast Cancer The safety data below were collected from 1492 women who received doxorubicin hydrochloride at a dose of 60 mg/m 2 and cyclophosphamide at a dose of 600 mg/m 2 (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer.

The median number of cycles received was

Selected adverse reactions reported in this study are provided in Table

No treatment-related deaths were reported in patients on either arm of the study.

Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes Adverse Reactions AC Includes pooled data from patients who received either AC for 4 cycles or AC for 4 cycles followed by CMF for 3 cycles N = 1492 Conventional CMF N = 739 % % AC = doxorubicin hydrochloride, cyclophosphamide;