Important Safety Information

WARNING: Taxotere® treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood-cell counts, allergic reaction, and retention of excess fluid (edema).

Taxotere® should not be given to patients with low white–blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere® or any of the ingredients in Taxotere®.

Before each Taxotere® treatment, all patients treated with Taxotere® must receive another medicine called dexamethasone. This drug can help reduce the risk of fluid retention (edema) and allergic reactions.

Taxotere® should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere® in adjuvant therapy for breast cancer.

The most common severe side effects are low white–blood-cell count, anemia, fatigue, diarrhea, and mouth and throat irritation. Low white–blood-cell count can lead to life-threatening infections. The earliest sign of infection may be fever, so tell your doctor right away if you have a fever.

Other common side effects from Taxotere® include nausea, vomiting, hair loss, rash, infusion-site reactions, odd sensations (such as numbness, tingling, or burning) or weakness in the hands and feet, nail changes, muscle and/or bone pain, or excessive tearing.

Because of the potential risk of fetal harm, pregnant women should not receive Taxotere®. Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere®.

Before receiving Taxotere®, tell your doctor if

• You have any allergies
• You are taking any other medicines — including nonprescription (over-the-counter) drugs, vitamins, and dietary or herbal supplements

When taking Taxotere®, contact your doctor if

• You have symptoms of an allergic reaction (warm sensation, tightness in your chest, itching/hives, or shortness of breath)
• You experience any other side effects

Please see adjacent page for patient information leaflet for detailed information about these side effects, and talk to your doctor about any questions you may have.