docetaxel

Generic Name: docetaxel (doe se TAX el)
Brand Name: Docefrez, Taxotere

What is docetaxel?

Docetaxel is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Docetaxel is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head/neck cancer.

Docetaxel may also be used for purposes not listed in this medication guide.

What is the most important information I should know about docetaxel?

Docetaxel can cause life-threatening side effects, especially if you have liver disease or if you have ever had a severe allergic reaction to docetaxel.

Docetaxel can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

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Docetaxel may cause fluid retention or severe skin reactions. Tell your doctor if you have swelling of your ankles or feet, rapid weight gain, or redness and peeling of the skin on your hands or feet.

Docetaxel can also affect your nervous system. Tell your doctor if you have any numbness, burning pain, tingly feeling, or severe weakness.

What should I discuss with my healthcare provider before receiving docetaxel?

You should not use this medication if you are allergic to docetaxel, or to drugs made with polysorbate 80.

To make sure docetaxel is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease;

• heart disease, congestive heart failure;

• fluid retention or swelling problems; or

• if you have ever had an allergic reaction to docetaxel.

FDA pregnancy category D. Do not use docetaxel if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether docetaxel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving docetaxel.

Older adults may be more likely to have side effects from this medicine.

How is docetaxel given?

Docetaxel is injected into a vein through an IV. A healthcare provider will give you this injection. You may receive other cancer medicines at the same time.

You may need to take a steroid medicine for a few days before your docetaxel injection. This may help prevent certain side effects of docetaxel. Try not to miss any doses of your steroid medication.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when docetaxel is injected.

Docetaxel can be harmful if it gets on your skin during an IV infusion. If this happens, wash right away with soap and water.

Docetaxel can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your docetaxel injection, or if you miss a dose of your steroid medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving docetaxel?

Avoid coming into contact with your body fluids (including urine, feces, vomit, semen, vaginal fluid). Chemotherapy can pass into body fluids. Patients or caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Docetaxel side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, red skin rash; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• extreme weakness;

• severe vomiting or diarrhea;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling of your ankles or feet, rapid weight gain;

• urinating less than usual or not at all;

• redness or peeling of the skin on your hands and feet;

• numbness, burning pain, or tingly feeling; or

• redness, swelling, burning, irritation, or skin changes where the injection was given.

Common side effects may include:

• feeling weak or tired;

• nausea, vomiting, diarrhea, constipation;

• muscle pain;

• altered sense of taste;

• temporary hair loss; or

• fingernail or toenail changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: docetaxel side effects (in more detail)

Docetaxel Dosing Information

Usual Adult Dose for Non-Small Cell Lung Cancer:

Initial dose: 75 mg/m2 IV over one hour. Courses of docetaxel may be repeated at 3 week intervals, after adequate recovery from toxicity.

When docetaxel is used as monotherapy for NSCLC treatment after failure of prior platinum based chemotherapy, the following guidelines apply: For patients who are dosed initially at 75 mg/m2 and who experience either febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or other grade 3 or 4 nonhematologic toxicities during docetaxel treatment should have treatment withheld until resolution of the toxicity and then resumed at 55 mg/m2. Patients who develop a grade 3 or greater peripheral neuropathy should have docetaxel treatment discontinued entirely.

When docetaxel is used as a part of combination chemotherapy in chemotherapy-naive NSCLC patients, the following guidelines apply: For patients who are dosed initially at 75 mg/m2 in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is less than 25,000 cells/mm3, in patients who experience febrile neutropenia, and in patients with serious nonhematologic toxicities, the docetaxel dosage in subsequent cycles should be reduced to 65 mg/m2. In patients who require a further dose reduction, a dose of 50 mg/m2 of docetaxel is recommended.

Usual Adult Dose for Breast Cancer:

Locally advanced or metastatic breast cancer after failure of prior treatment:
60 to 100 mg/m2 IV over one hour. Courses of docetaxel (as a single agent) may be repeated at 3 week intervals, after adequate recovery from toxicity.

Patients who are initially dosed at 100 mg/m2 and who experience either febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during therapy should have their dosage decreased to 75 mg/m2. If the patient continues to experience these reactions, the dosage should either be further decreased 55 mg/m2 or treatment should be discontinued. Conversely, patients who are dosed initially at 60 mg/m2 and who do not experience the above effects may tolerate higher doses. Patients who develop a grade 3 or greater peripheral neuropathy should have docetaxel treatment discontinued entirely. Patients initiated at 60 mg/m2 who do not develop toxicity may tolerate higher doses.

Docetaxel in combination with doxorubicin and cyclophosphamide recommended as adjuvant treatment of patients with operable node-positive breast cancer:
docetaxel 75 mg/m2 intravenously administered one 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 hematologic toxicities.

Docetaxel in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is greater than or equal to 1,500 cells/mm3. Patients who experience febrile neutropenia should receive G-CSF in all subsequent cycles. Patients who continue to experience this reaction should remain on G-CSF and have their docetaxel reduced to 60 mg/m2. Patients who experience severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have their dosage of docetaxel reduced from 75 mg/m2 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, treatment should be discontinued.

Patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g. 8 mg twice a day) for 3 days starting one day prior to docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.

Usual Adult Dose for Prostate Cancer:

Initial dose: Docetaxel 75 mg/m2 intravenously once over one hour. Prednisone 5 mg orally twice daily is administered continuously. 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. Courses of docetaxel may be repeated at 3 week intervals, after adequate recovery from toxicity.

Docetaxel should be administered when the neutrophil count is greater than or equal to 1,500 cells/mm3. Patients who experience either febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have the dosage of docetaxel reduced from 75 mg/m2 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.

Usual Adult Dose for Gastric Cancer:

Initial dose: Docetaxel 75 mg/m2 as a 1 hour intravenous infusion, 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.

Patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g. 8 mg twice a day) for 3 days starting one day prior to docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.

Patients treated with docetaxel in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In the study, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days. If an episode of febrile neutropenia, prolonged neutropenia, or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur, the docetaxel dose should be reduced from 60 mg/m2 to 45 mg/m2. In case of Grade 4 thrombocytopenia, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. Patients should not be treated with subsequent cycles of docetaxel until neutrophils recover to a level greater than 1,500 cells/mm3 and platelets recover to a level greater than 100,000 cells/mm3. Treatment should be discontinued if these toxicities persist.

The recommended dose modifications for gastrointestinal toxicities in patients treated with docetaxel in combination with cisplatin and fluorouracil are as follows:

Diarrhea grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, also reduce the docetaxel dose by 20%.

Diarrhea grade 4:
For the first episode, reduce the dose of both docetaxel and fluorouracil by 20%.
For the second episode, discontinue treatment.

Stomatitis grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, stop fluorouracil only, at all subsequent cycles.
For the third episode, reduce the dose of docetaxel by 20%.

Stomatitis grade 4:
For the first episode, stop fluorouracil only, at all subsequent cycles.
For the second episode, reduce the dose of docetaxel by 20%.

Usual Adult Dose for Head and Neck Cancer:

In combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck:

Initial dose: 75 mg/m2 as a 1 hour intravenous infusion
This is 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.

Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration). All patients on the docetaxel-containing arm of the TAX 323 study also received prophylactic antibiotics.

Patients treated with docetaxel in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In the study, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days. If an episode of febrile neutropenia, prolonged neutropenia, or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur, the docetaxel dose should be reduced from 60 mg/m2 to 45 mg/m2. In case of Grade 4 thrombocytopenia, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. Patients should not be treated with subsequent cycles of docetaxel until neutrophils recover to a level greater than 1,500 cells/mm3 and platelets recover to a level greater than 100,000 cells/mm3. Treatment should be discontinued if these toxicities persist.

The recommended dose modifications for gastrointestinal toxicities in patients treated with docetaxel in combination with cisplatin and fluorouracil are as follows:

Diarrhea grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, also reduce the docetaxel dose by 20%.

Diarrhea grade 4:
For the first episode, reduce the dose of both docetaxel and fluorouracil by 20%.
For the second episode, discontinue treatment.

Stomatitis grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, stop fluorouracil only, at all subsequent cycles.
For the third episode, reduce the dose of docetaxel by 20%.

Stomatitis grade 4:
For the first episode, stop fluorouracil only, at all subsequent cycles.
For the second episode, reduce the dose of docetaxel by 20%.

Usual Pediatric Dose for Solid Tumors:

The efficacy of docetaxel in pediatric patients as monotherapy or in combination has not been established. The overall safety profile in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.

Docetaxel monotherapy was evaluated in a dose-finding phase 1 trial in 61 pediatric patients (median age 12.5 years, range 1-22 years) with a variety of refractory solid tumors. The recommended dose was 125 mg/m2 as a 1-hour intravenous infusion every 21 days. The primary dose limiting toxicity was neutropenia.
The recommended dose for docetaxel monotherapy was evaluated in a phase 2 single-arm trial in 178 pediatric patients (median age 12 years, range 1-26 years) with a variety of recurrent/refractory solid tumors. Efficacy was not established with tumor response rates ranging from one complete response (CR) (0.6%) in a patient with undifferentiated sarcoma to four partial responses (2.2%) seen in one patient each with Ewing Sarcoma, neuroblastoma, osteosarcoma, and squamous cell carcinoma.

Docetaxel was studied in combination with cisplatin and 5-fluorouracil (TCF) versus cisplatin and 5-fluorouracil (CF) for the induction treatment of nasopharyngeal carcinoma (NPC) in pediatric patients prior to chemoradiation consolidation. Seventy-five patients (median age 16 years, range 9 to 21 years) were randomized (2:1) to docetaxel (75 mg/m2) in combination with cisplatin (75 mg/m2) and 5-fluorouracil (750 mg/m2) (TCF) or to cisplatin (80 mg/m2) and 5-fluorouracil (1000 mg/m2/day) (CF). The primary endpoint was the CR rate following induction treatment of NPC. One patient out of 50 in the TCF group (2%) had a complete response while none of the 25 patients in the CF group had a complete response.

What other drugs will affect docetaxel?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with docetaxel, especially:

• imatinib;

• nefazodone;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• heart medication--nicardipine, quinidine;

• hepatitis C medications--boceprevir, telaprevir; or

• HIV or AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

This list is not complete. Other drugs may interact with docetaxel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

• Your doctor or pharmacist can provide more information about docetaxel.