docetaxel

Pronunciation

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?

You should not receive this medicine if you have ever had a severe allergic reaction to docetaxel or to any medicine that contains polysorbate 80.

Docetaxel can cause severe side effects including death, especially if you receive high doses, if you have liver disease, or if you have non-small cell lung cancer and you have been treated in the past with chemotherapy that contains platinum (cisplatin, carboplatin, oxaliplatin).

Slideshow: 2013 Drug News Round-Up - Top 20 Stories

Docetaxel can also cause a life-threatening allergic reaction. 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.

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.

Docetaxel may cause fluid retention or severe skin reactions. Call 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.

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

You should not receive this medicine if you have a low white blood cell (WBC) count, or if you have ever had a severe allergic reaction to docetaxel or to any medicine that contains polysorbate 80.

Tell your doctor about your complete health history and all medications you have used. Docetaxel can cause severe side effects including death, especially:

  • if you receive high doses;

  • if you have liver disease; or

  • if you have non-small cell lung cancer and you have been treated in the past with chemotherapy that contains platinum (cisplatin, carboplatin, oxaliplatin).

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

  • kidney disease;

  • a history of liver disease or alcoholism;

  • heart disease, congestive heart failure;

  • fluid retention or swelling problems;

  • an allergy to any medicines;

  • if you need to limit your alcohol intake; or

  • if you have lung cancer and you have received docetaxel in the past.

Using docetaxel may increase your risk of developing other types of cancer, such as leukemia. Ask your doctor about your specific risk.

FDA pregnancy category D. Do not use docetaxel if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with docetaxel. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

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.

How is docetaxel given?

Docetaxel is injected into a vein through an IV, usually once every 3 weeks. A healthcare provider will give you this injection. You may receive other cancer medicines at the same time.

You may also need to take an oral steroid medicine to help prevent certain side effects of docetaxel. The steroid is usually taken within 12 to 24 hours before your docetaxel injection, and may be continued for a day or two afterward. 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.

You may need to have your vision checked if you have any vision problems while receiving docetaxel.

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 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 contains alcohol and may cause a drunken feeling when the medicine is injected into your vein. Avoid drinking alcohol on the day of your docetaxel injection.

This medicine may impair your thinking or reactions for 1 to 2 hours after injection. Be careful if you drive or do anything that requires you to be alert.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and 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.

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:

  • sudden vision problems;

  • extreme weakness, severe vomiting or diarrhea;

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

  • numbness, burning pain, or tingly feeling;

  • a feeling of being drunk--confusion, stumbling, extreme drowsiness;

  • signs of infection--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

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

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

  • fluid retention--little or no urinating, swelling of your ankles or feet, rapid weight gain; or

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

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

Common side effects may include:

  • mild weakness;

  • altered sense of taste;

  • nausea, vomiting, loss of appetite;

  • constipation, diarrhea;

  • temporary hair loss;

  • muscle pain;

  • mild skin rash; 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: 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?

Docetaxel contains alcohol. Using other drugs that can make you sleepy can worsen the feeling of being drunk. Ask your doctor before taking a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with docetaxel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about docetaxel.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.02. Revision Date: 2014-07-22, 1:38:03 PM.

Hide
(web3)