Docetaxel

Docetaxel is a prescription medication used to treat certain types of breast, lung, prostate, stomach, and head and neck cancers.  It may be used alone or in combination with other medicines. Docetaxel belongs to a group of drugs called taxanes, which stop the growth and spread of cancer cells.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider, once every 3 weeks.

Common side effects of docetaxel include changes in taste, anemia, nausea, vomiting, and hair loss.

Docetaxel is a prescription anti-cancer medicine used to treat certain people with:

• breast cancer
• non-small cell lung cancer
• prostate cancer
• stomach cancer
• head and neck cancer

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

Docetaxel may be found in some form under the following brand names:

• Docefrez

• Taxotere

Docetaxel may cause serious side effects. See "Drug Precautions" section.

The most common side effects of docetaxel include:

• changes in your sense of taste
• feeling short of breath
• constipation
• decreased appetite
• changes in your fingernails or toenails
• swelling of your hands, face or feet
• feeling weak or tired
• joint and muscle pain
• nausea and vomiting
• diarrhea
• mouth or lips sores
• hair loss
• rash
• redness of the eye, excess tearing
• skin reactions at the site of docetaxel administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin.
• tissue damage if docetaxel leaks out of the vein into the tissues

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of docetaxel. For more information ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ketoconazole
• ritonavir
• rifampin
• rifabutin

This is not a complete list of docetaxel drug interactions. Ask your doctor or pharmacist for more information.

Docetaxel may cause serious side effects including death. See the Black Box Warning.

• Acute Myeloid Leukemia (AML), a type of blood cancer, can happen in people who take docetaxel along with certain other medicines. Tell your doctor about all the medicines you take.
• Other blood disorders or changes in blood counts due to leukemia and other blood disorders may occur years after treatment with docetaxel.
• Skin reactions including redness and swelling of your arms and legs with peeling of your skin may occur.
• Neurologic symptoms including numbness, tingling, or burning in your hands and feet can happen with this medication.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of docetaxel there are no specific foods that you must exclude from your diet when receiving docetaxel.

Before you receive docetaxel, tell your doctor if you:

• are allergic to any medicines
• have liver problems
• have any other medical conditions
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Docetaxel may affect the way other medicines work, and other medicines may affect the way docetaxel works.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. It has been shown that use of docetaxel in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if docetaxel is excreted in human breast milk or if it will harm your nursing baby.

• Docetaxel will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
• Docetaxel is usually given every 3 weeks.
• Your doctor will decide how long you will receive treatment with docetaxel.
• Your doctor will check your blood cell counts and other blood tests during your treatment with docetaxel to check for side effects.
• Your doctor may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while taking docetaxel.

Your doctor will determine the dose and schedule of your docetaxel treatments depending on your condition and your response to the medicine. Your height and weight are used to calculate the dose as well.

Breast Cancer

• For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of docetaxel is 60 mg/m2 to 100 mg/m2 administered intravenously (throught the vein) over 1 hour every 3 weeks.
• For the adjuvant treatment of operable node-positive breast cancer, the recommended docetaxel dose is 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.

Non-Small Cell Lung Cancer

• For treatment after failure of prior platinum-based chemotherapy, docetaxel was evaluated as monotherapy, and the recommended dose is 75 mg/m2 administered intravenously (through the vein) over 1 hour every 3 weeks. A dose of 100 mg/m2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized, controlled trials.
• For chemotherapy-naïve patients, docetaxel was evaluated in combination with cisplatin. The recommended dose of docetaxel is 75 mg/m2 administered intravenously (through the vein) over 1 hour immediately followed by cisplatin 75 mg/m2 over 30–60 minutes every 3 weeks.

Prostate Cancer

• For hormone-refractory metastatic prostate cancer, the recommended dose of docetaxel is 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion (through the vein). Prednisone 5 mg orally twice daily is administered continuously.

Gastric Adenocarcinoma

• For gastric adenocarcinoma, the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion (through the vein), followed by cisplatin 75 mg/m2, as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.

Head and Neck Cancer

Patients must receive premedication with antiemetics, and appropriate hydration (prior to and after cisplatin administration). Prophylaxis for neutropenic infections should be administered. All patients treated on the docetaxel containing arms of the TAX323 and TAX324 studies received prophylactic antibiotics.

• Induction chemotherapy followed by radiotherapy (TAX323) 
  For the induction treatment of locally advanced inoperable SCCHN, the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion followed by cisplatin 75 mg/m2 intravenously over 1 hour, on day one, followed by fluorouracil as a continuous intravenous infusion at 750 mg/m2 per day for five days. This regimen is administered every 3 weeks for 4 cycles. Following chemotherapy, patients should receive radiotherapy.

• Induction chemotherapy followed by chemoradiotherapy (TAX324) 
  For the induction treatment of patients with locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN, the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3 hour infusion, followed by fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4. This regimen is administered every 3 weeks for 3 cycles. Following chemotherapy, patients should receive chemoradiotherapy.

Premedication Regimen

All patients should be premedicated with oral corticosteroids (see below for prostate cancer) such as dexamethasone 16 mg per day (e.g., 8 mg BID) for 3 days starting 1 day prior to docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.

For hormone-refractory metastatic prostate cancer, given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the docetaxel infusion.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all scheduled medical appointments. Your doctor will need to periodically monitor your progress and check for side effects. Be sure to keep appointments for laboratory and/or medical tests (e.g., blood cell counts and liver function tests) 
• Monitor your body temperature regularly and immediately tell your doctor if you develop a fever.
• Tell your doctor right away if you develop signs of allergy (hypersensitivity).
• Watch for signs of fluid retention such as swelling of legs and ankles, weight gain, and difficulty breathing.

Docetaxel can cause serious side effects, including death.

The chance of death in people who receive docetaxel is higher if you:

• have liver problems
• receive high doses of docetaxel
• have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum

Docetaxel can affect your blood cells. Your doctor should do routine blood tests during treatment with docetaxel. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your doctor may not treat you with docetaxel until you have enough white blood cells. People with low white blood counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your doctor's instructions for how often to take your temperature while taking docetaxel. Call your doctor right away if you have a fever.

Serious allergic reactions can happen in people who take docetaxel. Serious allergic reactions are medical emergencies that can lead to death and must be treated right away. Tell your doctor right away if you have any of these signs of a serious allergic reaction:

• trouble breathing
• sudden swelling of your face, lips, tongue, throat, or trouble swallowing
• hives (raised bumps), rash, or redness all over your body

Your body may hold too much fluid (severe fluid retention) during treatment with docetaxel. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each docetaxel treatment. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your docetaxel treatment if you forget to take the corticosteroid dose or do not take it as your doctor tells you.