Taxotere contains the active ingredient docetaxel, which is in an anhydrous form. It is an antineoplastic agent from the taxoid family and is available as a sterile injection at a concentration of 20 mg/mL. The injection comes in single-dose vials with dosage strengths of 20 mg, 80 mg, or 160 mg, and is ready to be added to an infusion solution for injection. Key inactive ingredients include polysorbate 80, dehydrated alcohol, and anhydrous citric acid for pH adjustment.

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in vision such as blurry vision, seeing halos around lights, vision loss -Infection—fever, chills, cough, or sore throat -Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded -Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing -Pain, tingling, or numbness in the hands or feet -Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting -Swelling of the ankles, hands, or feet -Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain -Unusual bruising or bleeding Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Change in nail shape, thickness, or color -Change in taste -Hair loss -Increased tears

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Kidney disease -Liver disease -Low white blood cell levels -Tingling of the fingers or toes or other nerve disorder -An unusual or allergic reaction to docetaxel, polysorbate 80, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Live virus vaccines This medication may also interact with the following: -Certain antibiotics, such as clarithromycin, telithromycin -Certain antivirals for HIV or hepatitis -Certain medications for fungal infections, such as itraconazole, ketoconazole, voriconazole -Grapefruit juice -Nefazodone -Supplements, such as St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop. You may need blood work done while you are taking this medication. This medication can cause serious side effects and infusion reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Be sure to follow the directions from your care team. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever. Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication. Some products may contain alcohol. Ask your care team if this medication contains alcohol. Be sure to tell all care teams you are taking this medicine. Certain medications, like metronidazole and disulfiram, can cause an unpleasant reaction when taken with alcohol. The reaction includes flushing, headache, nausea, vomiting, sweating, and increased thirst. The reaction can last from 30 minutes to several hours. This medication may affect your coordination, reaction time, or judgement. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or if you get pregnant within 2 months after stopping therapy. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 2 months after stopping it. Talk to your care team about reliable forms of contraception. Do not breast-feed while taking this medication and for 1 week after stopping therapy. Use a condom during sex and for 4 months after stopping therapy. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects. This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

This medication can decrease white blood cell levels in your body. White blood cells help protect your body from infection. Your care team will check your blood cell levels while you are taking this medication. Talk to your care team right away if you have symptoms of an infection, such as fever, chills, cough, sore throat, or general feeling of discomfort or being unwell. You should not receive this medicine if you have had an allergic reaction to Polysorbate 80. This medicine can cause a serious and life-threatening allergic reaction. It can happen after your first dose of this medicine or after receiving additional doses even if you did not previously have an allergic reaction. Your healthcare provider will watch you closely for an allergic reaction when you receive this medicine. This medicine increases the risk of death in certain people with lung cancer. Risk of death is higher if you: have non-small cell lung cancer; got platinum chemotherapy treatment; have liver problems; and get high doses of this medicine. Tell your healthcare provider if you have any problems with your liver or biliary tract. There is a higher risk of serious, life-threatening reactions when this medicine is given to those with liver disease. Severe infections, bleeding, mouth sores, skin toxicity, and death have been reported. Your healthcare provider will check your liver before each cycle with this medicine. This medicine may cause severe, life-threatening fluid retention. Your healthcare provider will give you a corticosteroid medicine to decrease the risk of fluid retention. Take the corticosteroid exactly as instructed.