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 accompanying full prescribing information,
including boxed WARNING.
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here for information on drug anti-counterfeiting.
Taxotere® (docetaxel) Injection Concentrate Indications
Breast Cancer
TAXOTERE® is indicated for the treatment of patients with locally
advanced or metastatic breast cancer after failure of prior chemotherapy
TAXOTERE® in combination with doxorubicin and cyclophosphamide is
indicated for the adjuvant treatment of patients with operable node-positive breast
cancer
Non-Small Cell Lung Cancer
TAXOTERE®, as a single agent, is indicated for the treatment of patients
with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure
of prior platinum-based chemotherapy
TAXOTERE® in combination with cisplatin is indicated for the treatment
of patients with unresectable, locally advanced or metastatic NSCLC who have not
previously received chemotherapy for this condition.
Prostate Cancer
TAXOTERE® in combination with prednisone is indicated for the treatment
of patients with androgen independent (hormone refractory) metastatic prostate cancer.
Gastric Cancer
TAXOTERE® in combination with cisplatin and fluorouracil is indicated
for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma
of the gastroesophageal junction, who have not received prior chemotherapy for advanced
disease.
Head and Neck Cancer
TAXOTERE® in combination with cisplatin and fluorouracil is indicated
for the induction treatment of patients with locally advanced squamous cell carcinoma
of the head and neck (SCCHN).