What Docetaxel Injection Concentrate is used for and how to use it
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Docetaxel (doe-se-Taks-el) Injection Concentrate – Consumer Medicine Information

Manufacture: Actavis
Country: United States
Condition: Breast Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Stomach Cancer
Class: Antineoplastic detoxifying agents, Mitotic inhibitors
Form: Liquid solution, Intravenous (IV)
Ingredients: Docetaxel, Citric Acid Anhydrous, Kollidon 12 Pf (povidone P12), Polysorbate 80, Ethanol

Intravenous Infusion

Read this Patient Information before you receive your first treatment with docetaxel injection concentrate 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 docetaxel injection concentrate?

Docetaxel injection concentrate can cause serious s ide effects, including death.

  • The chance of death in people who receive docetaxel injection concentrate is higher if you:
    • have liver problems
    • receive high doses of docetaxel injection concentrate
    • have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
  • Docetaxel injection concentrate can affect your blood cells . Your doctor should do routine blood tests during treatment with docetaxel injection concentrate. 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 docetaxel injection concentrate 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 docetaxel injection concentrate. Call your doctor right away if you have a fever.
  • Serious allergic reactions can happen in people who take docetaxel injection concentrate. 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
  • Your body may hold too much fluid (severe fluid retention) during treatmentwith docetaxel injection concentrate. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each docetaxel injection concentrate treatment. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your docetaxel injection concentrate treatment if you forget to take corticosteroid dose or do not take it as your doctor tells you.

What is docetaxel injection concentrate?

Docetaxel injection concentrate 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
  • The effectiveness of docetaxel injection concentrate in children has not been established.

Who should not take docetaxel injection concentrate?

Do not take docetaxel injection concentrate if you:

  • have had a severe allergic reaction to:
  • docetaxel, the active ingredient in docetaxel injection concentrate, 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 docetaxel injection concentrate?” 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 docetaxel injection concentrate?

Before you receive docetaxel injection concentrate, tell your doctor if you:

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Docetaxel injection concentrate may affect the way other medicines work, and other medicines may affect the way docetaxel injection concentrate works.

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

How will I receive docetaxel injection concentrate?

  • Docetaxel injection concentrate will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
  • Docetaxel injection concentrate is usually given every 3 weeks.
  • Your doctor will decide how long you will receive treatment with docetaxel injection concentrate.
  • Your doctor will check your blood cell counts and other blood tests during your treatment with docetaxel injection concentrate to check for side effects of docetaxel injection concentrate.
  • 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 taking docetaxel injection concentrate.

What are the possible side effects of docetaxel injection concentrate?

Docetaxel injection concentrate may cause serious side effects including death.

  • See “What is the most important information I should know about docetaxel injection concentrate?”
  • Acute Myeloid Leukemia (AML), a type of blood cancer, can happen in people who take docetaxel injection concentrate 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 docetaxel injection concentrate.
  • 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.

The most common side effects of docetaxel injection concentrate 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 docetaxel injection concentrate administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin
  • tissue damage if docetaxel injection concentrate leaks out of the vein into the tissues

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

These are not all the possible side effects of docetaxel injection concentrate. 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 docetaxel injection concentrate

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 docetaxel injection concentrate. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about docetaxel injection concentrate that is written for health professionals.

For more information call Actavis at 1-800-432-8534.

What are the ingredients in docetaxel injection concentrate?

Active ingredient: docetaxel

Inactive ingredients : citric acid anhydrous, kollidon 12 PF (povidone P12), polysorbate 80 and ethanol