Docivyx 80 mg/8 mL (10 mg/mL) intravenous solution

Generic name:
Docetaxel - injection

Pronunciation
(doh-seh-TAX-ell)

Brand name(s)
Taxotere

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."

Before using this medication, tell your doctor you medical history, especially of liver problems, current/recent infections, and low blood cell counts. Your doctor should monitor your labs (such as liver function, blood counts) closely while you are receiving this medication.

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.

Read the Patient Information Leaflet if available from your pharmacist before you start receiving docetaxel and each time you get a treatment. If you have any questions, ask your doctor, nurse, or pharmacist.

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

Your doctor may prescribe pre-medications (such as 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.

See also Warning section.

Pain or swelling at the injection site, nausea, vomiting, diarrhea, excessive tearing, tiredness, dizziness, drowsiness, feeling drunk, constipation, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell 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, hair loss may be permanent for some people.

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

Tell your doctor right away if you have any serious side effects, including:

• unusual tiredness/weakness
• swelling ankles/feet/hands
• unexplained weight gain
• swelling abdomen
• easy bruising/bleeding
• mouth sores
• numbness/tingling of arms/legs
• muscle/joint pain
• eye pain
• irregular heartbeat
• stomach/abdominal pain
• severe diarrhea
• diarrhea with blood or mucus
• severe headache

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.

Docetaxel sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain (flank pain)
• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

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.

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 (such as pulmonary effusions)
• heart problems (such as heart failure)
• weak immune system (such as neutropenia)
• blood problems (such as 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).

Docetaxel can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using docetaxel before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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

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. Men and women using this medication should ask about reliable forms of birth control during treatment and for some time after the last dose. If you or your partner becomes 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, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

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), ritonavir, HIV drugs (such as atazanavir), 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.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as blood cell counts, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.