"May 14, 2013 -- Actress and activist Angelina Jolie's recent decision to have a preventive double mastectomy highlights the difficult choices facing women who find out they have a high risk for breast cancer because of their genes.
(docetaxel) for Injection
Read this Patient Information before you receive your first treatment with DOCEFREZ 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 DOCEFREZ?
DOCEFREZ can cause serious side effects, including death.
1. The chance of death in people who receive DOCEFREZ is higher if you:
- have liver problems
- receive high doses of DOCEFREZ
- have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
2. DOCEFREZ can affect your blood cells. Your doctor should do routine blood tests during treatment with DOCEFREZ. 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 DOCEFREZ 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 DOCEFREZ. Call your doctor right away if you have a fever.
3. Serious allergic reactions can happen in people
who take DOCEFREZ. 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 DOCEFREZ. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each DOCEFREZ treatment. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your DOCEFREZ treatment if you forget to take corticosteroid dose or do not take it as your doctor tells you.
What is DOCEFREZ?
DOCEFREZ is a prescription anti-cancer medicine used to treat certain people with:
The effectiveness of DOCEFREZ in children has not been established.
Who should not take DOCEFREZ?
Do not take DOCEFREZ if you:
- have had a severe allergic reaction to:
- docetaxel, the active ingredient in DOCEFREZ, 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 DOCEFREZ?” 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 DOCEFREZ?
Before you receive DOCEFREZ, tell your doctor if you:
- are allergic to any medicines. See “Who should not take DOCEFREZ?” Also, see the end of this leaflet for a list of the ingredients in DOCEFREZ.
- have liver problems
- have any other medical conditions
- are pregnant or plan to become pregnant. DOCEFREZ can harm your unborn baby.
- are breast-feeding or plan to breast-feed. It is not known if DOCEFREZ passes into your breast milk. You and your doctor should decide if you will take DOCEFREZ or breast-feed.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. DOCEFREZ may affect the way other medicines work, and other medicines may affect the way DOCEFREZ 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 DOCEFREZ?
- DOCEFREZ will be given to you as an intravenous injection into your vein, usually over 1 hour.
- DOCEFREZ is usually given every 3 weeks.
- Your doctor will decide how long you will receive treatment with DOCEFREZ
- Your doctor will check your blood cell counts and other blood tests during your treatment with DOCEFREZ to check for side effects of DOCEFREZ.
- 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 DOCEFREZ.
What are the possible side effects of DOCEFREZ?
DOCEFREZ may cause serious side effects including death.
- See “What is the most important information I should know about DOCEFREZ?”
- Acute Myeloid Leukemia (AML), a type of blood cancer, can happen in people who take DOCEFREZ along with certain other medicines. Tell your doctor about all the medicines you take.
- Other Blood Disorders – Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docefrez.
- 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 DOCEFREZ include:
- changes in your sense of taste
- feeling short of breath
- 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
- mouth or lips sores
- hair loss
- redness of the eye, excess tearing
- skin reactions at the site of DOCEFREZ administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin.
- tissue damage if DOCEFREZ 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 DOCEFREZ. For more information ask your doctor or pharmacist.
Call your doctor or for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.
General information about DOCEFREZ
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 DOCEFREZ. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about DOCEFREZ that is written for healthcare professionals.
For more information contact Caraco Pharmaceutical Laboratories, Ltd. at 1-800-818-4555.
What are the ingredients in DOCEFREZ?
Active ingredient: docetaxel
Inactive ingredients include: ethanol in polysorbate 80 (Diluent)
Last reviewed on RxList: 8/2/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Docefrez Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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