In the U.S.—

In Canada—

• Antineoplastic

Docetaxel ( doe-se-TAX-el) belongs to the group of medicines called antineoplastics. It is used to treat breast cancer, non-small cell lung cancer, and prostate cancer.

Docetaxel interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by docetaxel, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Docetaxel may also be used to treat other conditions as determined by your doctor.

Before you begin treatment with docetaxel, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Docetaxel is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For docetaxel, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to docetaxel. Also tell your health care professional if you are allergic to any other substances such as polysorbate 80.

Pregnancy—Tell your doctor if you are pregnant or if you intend to become pregnant. Studies in rats and rabbits have shown that docetaxel causes miscarriages and deaths of the fetus, as well as problems in the mother.

Be sure that you have discussed this with your doctor before taking this medicine. It is best to use some kind of birth control while you are receiving docetaxel. Tell your doctor right away if you think you have become pregnant while receiving docetaxel.

Breast-feeding—It is not known whether docetaxel passes into breast milk. However, because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—Docetaxel has been studied in a limited number of children. The study showed that children are especially sensitive to the effects of docetaxel and cannot be given usual doses of the medicine.

Older adults— Elderly people are especially sensitive to the effects of docetaxel. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving docetaxel, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with x-rays or cancer medicines—Docetaxel may increase the effects of these medicines or radiation therapy on the blood

• Erythromycins (medicine for infection) or
• Ketoconazole (e.g., Nizoral) or
• Midazolam (e.g., Versed) or
• Orphenadrine (e.g., Norflex) or
• Testosterone (male hormone) or
• Troleandomycin—Higher blood levels of docetaxel may occur, increasing the chance of serious side effects

• Alcohol abuse or history of—The risk of some side effects affecting the muscles and nerves may be increased

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Fluid in lungs—docetaxel may make your condition worse

• Infection—Docetaxel may decrease your body's ability to fight infection

• Liver disease—The chance of serious side effects is greatly increased

This medicine often causes nausea and vomiting, which is usually mild. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Your doctor may direct you to take a corticosteroid medicine such as dexamethasone (e.g., Decadron), starting the day before you receive an injection of docetaxel and may continue for a few days after a docetaxel treatment. This other medicine decreases the chance of an allergic reaction to docetaxel and certain other side effects. It is very important that you take each dose of the corticosteroid medicine as directed.

Dosing—

The dose of docetaxel will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, and whether or not other medicines are also being taken. If you are receiving docetaxel at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of docetaxel, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with docetaxel, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Docetaxel may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the past several months. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Docetaxel can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

• Less common
  • Black, tarry stools;  blood in urine or stools;  cough or hoarseness (accompanied by fever or chills);  difficult or labored breathing;  difficult or painful urination (accompanied by fever or chills) ;  difficulty swallowing;  dizziness;  fast heartbeat;  fever or chills;  heart problems;  hives;  itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue;  lower back or side pain (accompanied by fever or chills);  noisy, rattling breathing;  pinpoint red spots on skin;  shortness of breath;  skin rash;  tightness in chest;  troubled breathing while at rest;  unusual bleeding or bruising;  unusual tiredness or weakness;  wheezing 
  
  

• Rare
  • Chest pain;  fast or irregular heartbeat ;  shortness of breath 
  
  

Docetaxel sometimes causes allergic reactions, especially during the first few treatments. Tell your doctor or nurse right away if you notice back pain or itching during an injection. Your doctor or nurse will be watching out for other signs of an allergic reaction while you are receiving this medicine, and will be ready to treat any serious effects right away.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Swelling of abdomen, face, fingers, hands, feet, or lower legs ;  unusual tiredness or weakness;  weight gain 
  
  

• Less common
  • Red, scaly, swollen, or peeling areas of skin (severe) 
  
  

• Rare
  • Decrease in blood pressure, sometimes with dizziness or fainting ;  increase in blood pressure, sometimes with dizziness or headaches 
  
  

This medicine may also cause the following side effects that your doctor will watch out for:

• More common
  • Anemia;  low white blood cell count 
  
  

• Less common
  • High or low blood pressure;  low platelet count in blood 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• More common
  • Burning, numbness, tingling, or pain in arms, hands, legs, or feet;  congestion;  diarrhea ;  dryness or soreness of throat;  nausea;  skin rash or redness (mild);  sores or ulcers on the lips or tongue or inside the mouth;  weakness in arms, hands, legs, or feet 
  
  

• Less common
  • Bloody nose;  body aches or pain;  change in color of fingernails or toenails;  congestion;  dry, red, hot, or irritated skin at place of injection;  dryness or soreness of throat;  hoarseness;  headache;  loosening or loss of fingernails or toenails, sometimes painful;  pain in joints or muscles;  pain, swelling, or lump under the skin at place of injection;  runny nose;  tender, swollen glands in neck;  trouble in swallowing;  voice changes ;  vomiting 
  
  

This medicine usually causes a temporary loss of hair. After treatment with docetaxel has ended, normal hair growth should return.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, docetaxel is used in certain patients with the following medical conditions:

• Bladder cancer
• Esophageal cancer
• Head and neck cancer
• Lung cancer, small cell
• Ovarian cancer
• Stomach cancer

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.