Pronunciation:

doe-se-TAX-el

Brand Names:

• Taxotere

Dosage Forms:

• Powder for Solution
• Solution

Warnings:

Docetaxel should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

The incidence of treatment-related mortality associated with docetaxel therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m(2).

Docetaxel should generally not be given to patients with bilirubin greater than the upper limit of normal (ULN), or to patients with SGOT and/or SGPT greater than 1.5 times ULN concomitant with alkaline phosphatase greater than 2.5 times ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase greater than 1.5 times ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death. Bilirubin, SGOT or SGPT, and alkaline phosphatase values should be obtained prior to each cycle of docetaxel therapy and reviewed by the treating physician.

Docetaxel therapy should not be given to patients with neutrophil counts of less than 1500 cells/mm(3). In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood cell counts should be performed on all patients receiving docetaxel.

Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received the recommended 3-day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy. Docetaxel must not be given to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80.

Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) .

Treatment-related mortality is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy. Docetaxel should generally not be given to patients with abnormal liver enzymes or elevated bilirubin levels. These patients are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Docetaxel therapy should not be given to patients with neutrophil counts of less than 1500 cells/mm(3). Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported with therapy. Severe fluid retention may occur .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

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 This Medicine:

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.

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.

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.

Other medicines—

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

Other interactions—

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 This Medicine:

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 This Medicine:

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.

Side Effects of This Medicine:

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 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.