Docetaxel for Injection

TAXOTERE
(TAX-O-TEER)
(docetaxel) Injection Concentrate Intravenous Infusion

Read this Patient Information before you receive your first treatment with TAXOTERE and each time before you are treated. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about TAXOTERE?

TAXOTERE can cause serious side effects, including death.

1. The chance of death in people who receive TAXOTERE is higher if you:

• have liver problems
• receive high doses of TAXOTERE
• have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum

2. TAXOTERE can affect your blood cells. Your doctor should do routine blood tests during treatment with TAXOTERE. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your doctor may not treat you with TAXOTERE until you have enough white blood cells. People with low white blood counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your doctor's instructions for how often to take your temperature while taking TAXOTERE. Call your doctor right away if you have a fever.

3. Serious allergic reactions can happen in people who take TAXOTERE. Serious allergic reactions are medical emergencies that can lead to death and must be treated right away.

Tell your doctor right away if you have any of these signs of a serious allergic reaction:

• trouble breathing
• sudden swelling of your face, lips, tongue, throat, or trouble swallowing
• hives (raised bumps), rash, or redness all over your body

4. Your body may hold too much fluid (severe fluid retention) during treatment with TAXOTERE. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each TAXOTERE treatment. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your TAXOTERE treatment if you forget to take the corticosteroid dose or do not take it as your doctor tells you.

What is TAXOTERE?

TAXOTERE is a prescription anti-cancer medicine used to treat certain people with:

• breast cancer
• non-small cell lung cancer
• prostate cancer
• stomach cancer
• head and neck cancer

It is not known if TAXOTERE is effective in children.

Who should not receive TAXOTERE?

Do not receive TAXOTERE if you:

• have had a severe allergic reaction to:
  • docetaxel, the active ingredient in TAXOTERE, or
• any other medicines that contain polysorbate 80. Ask your doctor or pharmacist if you are not sure.
  See “What is the most important information I should know about TAXOTERE?” for the signs and symptoms of a severe allergic reaction.
• have a low white blood cell count.

What should I tell my doctor before receiving TAXOTERE?

Before you receive TAXOTERE, tell your doctor if you:

• are allergic to any medicines. See “Who should not receive TAXOTERE?” Also, see the end of this leaflet for a complete list of the ingredients in TAXOTERE.
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant. TAXOTERE can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if TAXOTERE passes into your breast milk. You and your doctor should decide if you will receive TAXOTERE or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAXOTERE may affect the way other medicines work, and other medicines may affect the way TAXOTERE works.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How will I receive TAXOTERE?

• TAXOTERE will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
• TAXOTERE is usually given every 3 weeks.
• Your doctor will decide how long you will receive treatment with TAXOTERE.
• Your doctor will check your blood cell counts and other blood tests during your treatment with TAXOTERE to check for side effects of TAXOTERE.
• Your doctor may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving TAXOTERE.

What are the possible side effects of TAXOTERE?

TAXOTERE may cause serious side effects including death.

• See “What is the most important information I should know about TAXOTERE?”
• Acute Myeloid Leukemia (AML), a type of blood cancer, can happen in people who take TAXOTERE along with certain other medicines.
• Other Blood Disorders. Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with TAXOTERE.
• Skin Reactions including redness and swelling of your arms and legs with peeling of your skin.
• Neurologic Symptoms including numbness, tingling, or burning in your hands and feet.
• Vision Problems including blurred vision or loss of vision.
• TAXOTERE Injection contains alcohol. The alcohol content in TAXOTERE Injection may impair your ability to drive or use machinery right after receiving TAXOTERE Injection. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive TAXOTERE Injection treatment.

The most common side effects of TAXOTERE include:

• changes in your sense of taste
• feeling short of breath
• constipation
• decreased appetite
• changes in your fingernails or toenails
• swelling of your hands, face or feet
• feeling weak or tired
• joint and muscle pain
• nausea and vomiting
• diarrhea
• mouth or lips sores
• hair loss
• rash
• redness of the eye, excess tearing
• skin reactions at the site of TAXOTERE administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin.
• tissue damage if TAXOTERE leaks out of the vein into the tissues

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of TAXOTERE. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about TAXOTERE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about TAXOTERE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TAXOTERE that is written for health professionals.

For more information, call 1-800-633-1610.

What are the ingredients in TAXOTERE?

Active ingredient: docetaxel

Inactive ingredients include: ethanol and polysorbate 80

Docetaxel is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Docetaxel is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head/neck cancer.

Docetaxel may also be used for purposes not listed in this medication guide.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.