Docetaxel Injection

IMPORTANT WARNING:

Tell your doctor if you have or have ever had liver disease or have ever been treated with cisplatin (Platinol) or carboplatin (Paraplatin) for lung cancer. You may have a higher risk of developing certain serious side effects such as low levels of certain types of blood cells, severe mouth sores, severe skin reactions, and death.

Docetaxel injection may cause low levels of white blood cells in the blood. Your doctor will order laboratory tests regularly during your treatment to check whether the number of white blood cells in your body has decreased. Your doctor may also recommend that you check your temperature frequently during your treatment. Follow these instructions carefully. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, or other signs of infection.

Docetaxel injection may cause severe allergic reactions. Tell your doctor if you are allergic to docetaxel injection or drugs made with polysorbate 80, an ingredient found in some medications. Ask your doctor if you are unsure if a medication you are allergic to contains polysorbate 80. If you experience any of the following symptoms, call your doctor immediately: rash, hives, itching, warm sensation, chest tightness, fainting, dizziness, nausea or difficulty breathing or swallowing.

Docetaxel injection may cause serious or life-threatening fluid retention (condition where the body keeps excess fluid). Fluid retention does not usually start immediately, and most commonly occurs around the fifth dosing cycle. If you experience any of the following symptoms, call your doctor immediately: swelling of the hands, feet, ankles, or lower legs; weight gain; shortness of breath; difficulty swallowing; hives; redness; rash; chest pain;cough; hiccups; rapid breathing; fainting; lightheadedness; swelling of the stomach area; pale, grayish skin; or pounding heartbeat.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to docetaxel injection.

Talk to your doctor about the risks of using docetaxel injection.

WHY is this medicine prescribed?

Docetaxel injection is used alone or in combination with other medications to treat certain types of breast, lung, prostate, stomach, and head and neck cancers. Docetaxel injection is in a class of medications called taxanes. It works by stopping the growth and spread of cancer cells.

Are there OTHER USES for this medicine?

Docetaxel injection is also sometimes used to treat ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed). Talk to your doctor about the risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Docetaxel injection comes as a liquid to be given intravenously (into a vein) by a doctor or nurse in a hospital or clinic. It is usually given over 1 hour once every 3 weeks. Your doctor will tell you how often you will receive docetaxel. The schedule depends on the condition you have and on how your body responds to the medication.

Your doctor will probably prescribe a steroid medication such as dexamethasone for you to take during each dosing cycle to help prevent certain side effects. Be sure to follow the directions carefully and take this medication exactly as prescribed. If you forget to take your medication or do not take it on schedule, be sure to tell your doctor before receiving your docetaxel injection.

Because certain docetaxel injection preparations contains alcohol, you may experience certain symptoms during or for 1–2 hours after your infusion. If you experience any of these symptoms, tell your doctor right away: confusion, stumbling, becoming very sleepy, or feeling like you are drunk.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using docetaxel injection,

• tell your doctor and pharmacist if you are allergic to docetaxel injection, paclitaxel (Abraxane, Taxol), any other medications, or any of the ingredients in docetaxel injection.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using docetaxel injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you drink or have ever drunk large amounts of alcohol.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. You should not become pregnant while you are using docetaxel injection. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for up to 6 months after your last dose. If you are a male, you and your female partner should use birth control during your treatment and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use to prevent pregnancy during this time. If you or your partner become pregnant while using docetaxel injection, call your doctor immediately. Docetaxel injection may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are using docetaxel injection and for 2 weeks after the final dose.

• you should know that docetaxel injection may contain alcohol that could make you drowsy or affect your judgment, thinking, or motor skills. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Call your doctor right away if you are unable to keep an appointment to receive a dose of docetaxel injection.

What SIDE EFFECTS can this medicine cause?

Docetaxel injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vomiting
• constipation
• changes in taste
• extreme tiredness
• muscle, joint, or bone pain
• hair loss
• nail changes
• increased eye tearing
• sores in the mouth and throat
• redness, dryness, or swelling at the site where the medication was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• blistering skin
• numbness, tingling, or burning sensation in the hands or feet
• weakness in the hands and feet
• unusual bleeding or bruising
• nosebleeds
• blurred vision
• loss of vision
• stomach pain or tenderness, diarrhea, or fever

Docetaxel injection may increase your risk of developing other cancers, such as blood or kidney cancer, several months or years after treatment. Your doctor will monitor you during and after your docetaxel treatment. Talk to your doctor about the risks of receiving this medication.

Docetaxel injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• sore throat, fever, chills, and other signs of infection
• sores in the mouth and throat
• skin irritation
• weakness
• numbness, tingling, or burning sensation in the hands or feet

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.