Sunday 25 December 2011

docetaxel


Generic Name: docetaxel (doe se TAX el)

Brand Names: 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?


Do not use docetaxel if you are pregnant. It could harm the unborn baby. You should not use this medication if you are allergic to docetaxel, or to drugs made with polysorbate 80.

Before you receive docetaxel, tell your doctor if you have liver or kidney disease, heart disease, congestive heart failure, or fluid retention or swelling problems.


You may need to take a steroid medicine to 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. To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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 you can safely receive docetaxel, tell your doctor if you have any of these other conditions:



  • 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. You will receive this injection in a clinic or hospital setting. Docetaxel must be given slowly, and the IV infusion can take up to 1 hour to complete. You may receive other cancer medicines at the same time.


Docetaxel is usually given once every 3 weeks, depending on the type of cancer being treated. Follow your doctor's instructions.


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. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.


To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

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.

Overdose symptoms may include some of the serious side effects listed in this medication guide.


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 side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • 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;




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




  • swelling of your ankles or feet, 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.



Less serious side effects may include:



  • feeling weak or tired;




  • mild nausea, vomiting, diarrhea, constipation, or loss of appetite;




  • muscle pain;




  • missed menstrual periods;




  • 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.


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 other medicines you use, especially:



  • conivaptan (Vaprisol);




  • imatinib (Gleevec);




  • isoniazid (for treating tuberculosis);




  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);




  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);




  • an antidepressant such as nefazodone;




  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others; or




  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra).



This list is not complete and other drugs may interact with docetaxel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More docetaxel resources


  • Docetaxel Side Effects (in more detail)
  • Docetaxel Dosage
  • Docetaxel Use in Pregnancy & Breastfeeding
  • Docetaxel Drug Interactions
  • Docetaxel Support Group
  • 1 Review for Docetaxel - Add your own review/rating


  • docetaxel Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Docefrez Prescribing Information (FDA)

  • Docetaxel Prescribing Information (FDA)

  • Docetaxel Professional Patient Advice (Wolters Kluwer)

  • Docetaxel Monograph (AHFS DI)

  • Docetaxel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Taxotere Prescribing Information (FDA)

  • Taxotere Consumer Overview



Compare docetaxel with other medications


  • Breast Cancer
  • Breast Cancer, Metastatic
  • Gastric Cancer
  • Head and Neck Cancer
  • Non-Small Cell Lung Cancer
  • Prostate Cancer
  • Solid Tumors


Where can I get more information?


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

See also: docetaxel side effects (in more detail)


Tuesday 20 December 2011

Zalidar Efe




Zalidar Efe may be available in the countries listed below.


Ingredient matches for Zalidar Efe



Paracetamol

Paracetamol is reported as an ingredient of Zalidar Efe in the following countries:


  • Portugal

Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Zalidar Efe in the following countries:


  • Portugal

International Drug Name Search

Sunday 18 December 2011

Dupofol




Dupofol may be available in the countries listed below.


Ingredient matches for Dupofol



Salicylic Acid

Salicylic Acid is reported as an ingredient of Dupofol in the following countries:


  • Argentina

International Drug Name Search

Wednesday 14 December 2011

Egilipid




Egilipid may be available in the countries listed below.


Ingredient matches for Egilipid



Simvastatin

Simvastatin is reported as an ingredient of Egilipid in the following countries:


  • Czech Republic

  • Poland

International Drug Name Search

Saturday 10 December 2011

Clotrimazol Vagin Bayhealth




Clotrimazol Vagin Bayhealth may be available in the countries listed below.


Ingredient matches for Clotrimazol Vagin Bayhealth



Clotrimazole

Clotrimazole is reported as an ingredient of Clotrimazol Vagin Bayhealth in the following countries:


  • Spain

International Drug Name Search

Thursday 8 December 2011

Ketorolaco Trometamol




Ketorolaco Trometamol may be available in the countries listed below.


Ingredient matches for Ketorolaco Trometamol



Ketorolac

Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Ketorolaco Trometamol in the following countries:


  • Chile

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Ruifulin




Ruifulin may be available in the countries listed below.


Ingredient matches for Ruifulin



Itopride

Itopride hydrochloride (a derivative of Itopride) is reported as an ingredient of Ruifulin in the following countries:


  • China

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