Docetaxel Side Effects

6 ADVERSE REACTIONS The most serious adverse reactions from docetaxel are: • Toxic Deaths [ see Boxed Warning , Warnings and Precautions (5.1) ] • Hepatic Impairment [ see Boxed Warning , Warnings and Precautions (5.2) ] • Hematologic Effects [ see Boxed Warning , Warnings and Precautions (5.3) ] • Enterocolitis and Neutropenic Colitis [ see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [ see Boxed Warning , Warnings and Precautions (5.5) ] • Fluid Retention [ see Boxed Warning , Warnings and Precautions (5.6) ] • Second Primary Malignancies [ see Warnings and Precautions (5.7) ] • Cutaneous Reactions [ see Warnings and Precautions (5.8) ] • Neurologic Reactions [ see Warnings and Precautions (5.9) ] • Eye Disorders [ see Warnings and Precautions (5.10) ] • Asthenia [ see Warnings and Precautions (5.11) ] • Alcohol Content [ see Warnings and Precautions (5.13) ] The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.

Incidence varies depending on the indication.

Adverse reactions are described according to indication.

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.

Responding patients may not experience an improvement in performance status on therapy and may experience worsening.

The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established.

Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc.

at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience Breast Cancer Monotherapy with Docetaxel for Locally Advanced or Metastatic Breast Cancer after Failure of Prior Chemotherapy Docetaxel 100 mg/m 2 : Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received docetaxel administered at 100 mg/m 2 as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests;