Taxotere

Generic Name: docetaxel (Intravenous route)

doe-se-TAX-el

Intravenous route(Solution)

Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based therapy receiving docetaxel at 100 mg/m(2). Docetaxel should generally not be given to patients with bilirubin greater than the ULN, or to patients with SGOT and/or SGPT greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN. These patients are at increased risk for developing severe or life-threatening toxicities. Monitor LFTs prior to each treatment cycle. Docetaxel therapy should not be given to patients with neutrophil counts of less than 1500 cells/mm(3); obtain frequent blood counts to monitor for neutropenia. Severe hypersensitivity reactions, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Use is contraindicated in patients with a severe hypersensitivity to docetaxel or polysorbate 80. Severe fluid retention may occur .

Commonly used brand name(s)

In the U.S.

• Docefrez


• Taxotere

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For Taxotere

Docetaxel belongs to the group of medicines called antineoplastics. It is used to treat breast cancer, non-small cell lung cancer, head and neck cancer , gastrointestinal (stomach) and prostate cancer. Docetaxel is sometimes used in combination with other medicines for certain types of 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.

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


• Lung cancer, small cell


• Ovarian cancer

Before Using Taxotere

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Atazanavir


• Bacillus of Calmette and Guerin Vaccine, Live


• Clarithromycin


• Doxorubicin Hydrochloride


• Indinavir


• Influenza Virus Vaccine, Live


• Itraconazole


• Ketoconazole


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Nefazodone


• Nelfinavir


• Ritonavir


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Saquinavir


• Smallpox Vaccine


• Telithromycin


• Thalidomide


• Typhoid Vaccine


• Varicella Virus Vaccine


• Voriconazole


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cisplatin


• Dalfopristin


• Quinupristin


• Sorafenib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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)—The risk of severe disease affecting other parts of the body may be increased.

• 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.

Proper Use of docetaxel

This section provides information on the proper use of a number of products that contain docetaxel. It may not be specific to Taxotere. Please read with care.

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using Taxotere

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.

Taxotere Side Effects

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.

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 or discomfort


• 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.

A kind of leukemia called acute myeloid leukemia [AML] can occur if you are taking a combination of docetaxel and cyclophosphamide to treat your breast cancer. Tell your doctor right away if you develop a lot of infections, experience bone or joint pain, or have a fever.

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

Some 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


• headache


• hoarseness


• 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

incidence not known

• Burning, dry or itching eyes


• burning upper abdominal pain


• confusion


• difficulty having a bowel movement [stool]


• discharge from eyes


• excessive tearing


• mood or mental changes


• pain all over body


• pain and redness of skin at place of earlier radiation treatment


• rapid breathing


• redness, pain, swelling of eye, eyelid, or inner lining of eyelid


• stomach pain


• sunken eyes


• tearing of the eyes


• wrinkled skin

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Taxotere side effects (in more detail)

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More Taxotere resources

• Taxotere Side Effects (in more detail)
• Taxotere Use in Pregnancy & Breastfeeding
• Taxotere Drug Interactions
• Taxotere Support Group
• 1 Review for Taxotere - Add your own review/rating

• Taxotere Consumer Overview


• Taxotere Prescribing Information (FDA)


• Taxotere Monograph (AHFS DI)


• Taxotere MedFacts Consumer Leaflet (Wolters Kluwer)


• Docefrez Prescribing Information (FDA)


• Docetaxel Professional Patient Advice (Wolters Kluwer)


• Docetaxel Prescribing Information (FDA)

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