Taxotere Vial

GENERIC NAME(S): Docetaxel

OTHER NAME(S): Taxotere Solution

WARNINGS:

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.

Get medical help right away 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.

Who should not take Taxotere Vial?

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Uses

Uses

This medication is used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). Docetaxel is a member of a family of drugs called taxanes. This drug works by slowing cell growth.

How to use Taxotere Vial

Read the Patient Information Leaflet available from your pharmacist. Consult your doctor, nurse or pharmacist if you have any questions.

This medication is given by injection into a vein by a health care professional, generally over 1 hour every 3 weeks or as directed by your doctor. The dosage and frequency is based on your medical condition, body size, and response to treatment.

Your doctor may prescribe pre-medications (e.g., corticosteroids such as dexamethasone) to prevent side effects like swelling (fluid retention/edema) and allergic reactions. These are generally started 1 day before treatment and continued for a total of 3 days. Carefully follow your doctor's orders to prepare for your treatment. If you forget to take your pre-medication, or do not take it on schedule, tell your doctor or nurse before you receive your docetaxel treatment.

Side Effects

Side Effects

See also Warning section.

Pain or swelling at the injection site, nausea, vomiting, diarrhea, excessive tearing, fatigue, dizziness, drowsiness, feeling drunk, 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 any of 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. However, in some cases, the hair loss may be permanent.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication can decrease your body's ability to fight an infection. Tell your doctor right away if you develop any signs of an infection (such as a sore throat that doesn't go away, fever, or chills).

Although docetaxel is used to treat cancer, it may rarely increase your risk of getting other cancers (such as acute myeloid leukemia-AML, Non-Hodgkin's Lymphoma, kidney cancer). This may occur months to years after treatment. Your doctor should monitor you closely while you receive this medication and after treatment with this medication.

Tell your doctor right away if you have any serious side effects, including: 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, irregular heartbeat, stomach/abdominal pain, severe diarrhea, diarrhea with blood or mucus, severe headache.

Get medical help right away if you have any very serious side effects, including: chest pain, vision changes (such as blurred vision, decreased vision, seeing flashes of light).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

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

Precautions

Precautions

See also Warning section.

Before using docetaxel, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (taxane-type drugs such as paclitaxel, cabazitaxel); or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate 80), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving docetaxel, tell your doctor or pharmacist your medical history, especially of: liver problems, lung problems (e.g., pulmonary effusions), heart problems (e.g., congestive heart failure), weak immune system (e.g., neutropenia), blood problems (e.g., anemia, thrombocytopenia), blood pressure problems.

This medication may make you dizzy or drowsy. It also contains alcohol, which can increase these symptoms and also make you feel drunk. Caution is advised if you have liver disease or any other condition that requires you to limit/avoid alcohol. Marijuana (cannabis) can also make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness for 1 to 2 hours after you receive this medication and until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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.

Older adults may be more sensitive to the side effects of this drug, especially anemia, dizziness, diarrhea, infection, swelling, mouth sores, and weight loss.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using docetaxel. Docetaxel may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should use reliable forms of birth control during treatment and for 6 months after stopping treatment. Men using this medication should use reliable forms of birth control during treatment and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 1 week after stopping treatment. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: medications that may have a bad reaction with alcohol (such as disulfiram, metronidazole, tinidazole).

Other medications can affect the removal of docetaxel from your body, which may affect how docetaxel works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), HIV drugs (such as ritonavir), St. John's wort, among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as other alcohol-containing medications or alcoholic beverages, marijuana (cannabis), opioid pain or cough relievers (such as codeine, hydrocodone), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (e.g., blood cell counts and liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all scheduled medical appointments.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic and will not be stored at home.Information last revised July 2019. Copyright(c) 2019 First Databank, Inc.

Images
Taxotere 20 mg/mL (1 mL) intravenous solution
Taxotere 20 mg/mL (1 mL) intravenous solutioniconicon
Taxotere 20 mg/mL (1 mL) intravenous solution

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Taxotere 80 mg/4 mL (20 mg/mL) intravenous solution
Taxotere 80 mg/4 mL (20 mg/mL) intravenous solutioniconicon
Taxotere 80 mg/4 mL (20 mg/mL) intravenous solution

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pale yellow
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No data.
Taxotere 20 mg/mL (1 mL) intravenous solution
Taxotere 20 mg/mL (1 mL) intravenous solution

color
pale yellow
shape
No data.
imprint
No data.
This medicine is a pale yellow, vial
Taxotere 80 mg/4 mL (20 mg/mL) intravenous solution
Taxotere 80 mg/4 mL (20 mg/mL) intravenous solution

color
pale yellow
shape
No data.
imprint
No data.
This medicine is a pale yellow, vial

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

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.