Generic Name: DOCETAXEL - INJECTION
Pronounced: (doh-seh-TAX-ell)

Taxotere IV Warning

Docetaxel has caused severe (rarely fatal) allergic reactions and swelling (fluid retention/edema) even with the use of preventive medications. This drug must not be used in patients who have previously had an allergic reaction to it or to other medications containing polysorbate 80.

There is an increased risk of serious (possibly fatal) reactions in patients using docetaxel who have liver problems, patients receiving higher doses, and patients with non-small cell lung cancer who have received certain other chemotherapy drugs known as "platinums."

If you have a low white blood cell count or liver problems, notify your doctor before using docetaxel.

Seek immediate medical attention if you experience swelling, dizziness or fainting, difficulty breathing, irregular heartbeat, severe swelling of the abdomen, skin rash, easy bleeding or bruising, sores in the mouth or throat, or symptoms of infection such as fever and sore throat.

Your doctor will closely monitor you and your blood counts and liver tests while you are receiving docetaxel.

Taxotere IV Side Effects

See also Warning section.

Pain or swelling at the injection site, nausea, vomiting, diarrhea, excessive tearing, fatigue, dizziness, constipation, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve nausea and vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss and nail changes may occur. Normal hair growth and nail appearance should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• swelling of the hands/feet/legs
• unexplained weight gain
• numbness or tingling of the hands or feet
• muscle or joint pain
• persistent weakness or fatigue
• eye pain

Tell your doctor immediately if any of these rare but very serious side effects occur:

• irregular heartbeat
• severe stomach pain
• black or bloody stools
• severe headache
• decrease in the amount of urine

Seek immediate medical attention if any of these rare but very serious side effects occur:

• chest pain

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Taxotere IV Precautions

Before receiving docetaxel, tell your doctor or pharmacist if you are allergic to it; or to other drugs containing polysorbate 80; or if you have any other allergies. This product may contain other inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Docetaxel should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• liver problems
• lung problems (e.g., pulmonary effusions)
• heart problems (e.g., congestive heart failure)
• weak immune system (e.g., neutropenia)

Before receiving docetaxel, tell your doctor or pharmacist your medical history, especially of:

• pregnancy
• blood problems (e.g., anemia, thrombocytopenia)
• blood pressure problems

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

This medication and the pre-medications that you take before you take docetaxel may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages as they may aggravate some of the side effects and make your stomach and intestines more likely to bleed.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially anemia, dizziness, diarrhea, infection, swelling, mouth sores, and weight loss.

This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby. Consult your doctor before taking docetaxel and discuss the use of reliable birth control methods during therapy and for 3 months afterwards. If you become pregnant or think you may be pregnant, inform your doctor immediately.

It is not known if this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Taxotere IV Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.