Highlights of prescribing information initial dose of. Docetaxel teva in combination with doxorubicin is indicated for the treatment of. Desferal deferoxamine mesylate for injection usp vials rx only prescribing information description desferal, deferoxamine mesylate usp, is an ironchelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Taxotere docetaxel injection, for intravenous use initial u.
Docetaxel hospira 10 mgml concentrate for solution for. Docetaxel dtx or dxl, sold under the brand name taxotere among others, is a chemotherapy medication used to treat a number of types of cancer. It can also be used with other cancer medicines capecitabine, cyclophosphamide, doxorubicin or trastuzumab in patients who have not yet received treatment for their cancer or after other treatments have failed, depending on the type and stage of. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are. The printed package leaflet of the medicinal product must state the name and. Jevtana is a prescription anticancer medicine used with the steroid medicine prednisone. Information for the user docetaxel ebewe 10 mgml concentrate for solution for infusion docetaxel read all of this leaflet carefully before you start using this medicine. Docetaxel injection usp is indicated for the treatment of patients with locally advanced or. Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel injection, for intravenous use initial u. Docetaxel accord is a cancer medicine used to treat the following types of cancer. Taxotere, in combination with doxorubicin as first line therapy, should be reserved for patients with potentially life threatening disease such as visceral or lung metastatic disease.
Docetaxel docetaxel injection, solution baxter healthcare corporationhighlights of prescribing information these highlights do not include all the information needed to use docetaxel injection safely and effectively. Docetaxel injection therapy should not be given to patients with neutrophil counts of 10 x uln or bilirubin 5 x uln. Docetaxel injection this product information is intended only for residents of the united states. Docetaxel injection, usp requires no prior dilution with a diluent and is ready to add to the infusion solution. Highlights of prescribing information adequately rehydrate. These highlights do not include all the information needed to use. Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. During and following paclitaxel, docetaxel, or docetaxelcarboplatin. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and nonsmallcell lung cancer. May be harmful by inhalation, ingestion, or skin absorption.
As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel. Dermatologic toxicities occurred in 90% of patients and were severe ncictc grade 3 and higher in 15% of patients receiving vectibix monotherapy see dosage and administration 2. Policy document for taxotere docetaxel docefrezdocetaxel. Dailymed docetaxel docetaxel anhydrous injection, solution. All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously. The most commonly reported adverse reactions of docetaxel alone are. For capecitabine dose modifications, see capecitabine summary of product. Premedication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the xeloda plus docetaxel combination. During and following paclitaxel, docetaxel, or docetaxel carboplatin.
Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention see full. Desferal is supplied as vials containing 500 mg of deferoxamine mesylate usp in sterile. Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable nodepositive breast cancer. The use of granulocyte colonystimulating factors was 42% in cyramza with docetaxel treated patients versus 37% in patients who received placebo with docetaxel. Information for the patient docetaxel accord 20 mg. Highrisk is defined as erprpositive with one of the following features. Taxotere is sterile, nonpyrogenic, and is available in. Highlights of prescribing information these highlights do not.
Previous therapy should have included an anthracycline. Docetaxel accord 160 mg8 ml concentrate for solution for infusion. Initial dose of 4 mgkg as an intravenous infusion over 90 minutes then at 2 mgkg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks paclitaxel or docetaxel or 18 weeks docetaxel carboplatin. Jevtana is used to treat men with castrationresistant prostate cancer prostate cancer that is resistant to medical or surgical treatments that lower testosterone that has worsened progressed after treatment with other medicines, including docetaxel. This leaflet is part iii of a threepart product monograph. Docetaxel is a white to almostwhite powder with an empirical formula of c 43 h 53 no 14, and a molecular weight of 807. Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and nonsmallcell lung cancer. Docetaxel clinical pharmacology mechanism of action. Patient counseling information and fdaapproved patient labeling revised.
Taxotere docetaxel injection concentrate is a clear yellow to brownishyellow. Docetaxel fda prescribing information, side effects and uses. Taxotere 20 mgml concentrate solution for injection, singleuse. Taxotere docetaxel injection concentrate is a clear yellow to brownishyellow viscous solution. Policy document for taxotere docetaxel docefrez docetaxel docetaxel generic the overall objective of this policy is to support the appropriate and cost effective use of the medication. It may be used by itself or along with other chemotherapy medication.
Policy document for taxotere docetaxel docefrezdocetaxel docetaxel generic the overall objective of this policy is to support the appropriate and cost effective use of the medication. Successful desensitization to docetaxel after severe. If you have any further questions, ask your doctor or pharmacist. Gemzar vials contain no antimicrobial preservatives and are intended for single use only.
Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer. Docetaxel injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant sections or subsections omitted from the full prescribing information are not listed. Highlights of prescribing information initial dose of 4 mg. Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
This document provides specific information to each section of the overall policy. See full prescribing information for docetaxel injection. Taxotere is used with prednisone or prednisolone antiinflammatory medicines when the cancer cannot be treated by greatly reducing the bodys production of testosterone castrationresistant prostate cancer. Docetaxel injection as a single agent is indicated for the treatment of patients with locally. Mar 12, 2020 docetaxel is a white to almostwhite powder with an empirical formula of c 43 h 53 no 14, and a molecular weight of 807. Docetaxel teva, inndocetaxel european medicines agency. Docetaxel injection, usp is a sterile, nonpyrogenic, clear, colorless to pale yellow solution at.
These highlights do not include all the information needed to use gamunex c safely and effectively. Treatmentrelated mortality increases with abnormal liver function, at higher doses, and in patients with nsclc and prior platinumbased therapy receiving docetaxel injection concentrate at 100 mgm. Docetaxel injection, usp is a sterile, nonpyrogenic, clear, colorless to pale yellow solution at 10 mgml concentration. See full prescribing information for complete boxed warning. Highlights of prescribing information initial dose of 4. Mar 15, 2012 the semisynthetic taxane derivative docetaxel has become vital to the treatment of many malignancies and has received approval from the food and drug administration for the treatment of early and advanced breast cancer, advanced nonsmall cell lung cancer, hormone refractory prostate cancer, advanced gastricgastroesophageal junction cancer, and locally advanced head and neck cancer.
Docetaxel 30 mgm 2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. The semisynthetic taxane derivative docetaxel has become vital to the treatment of many malignancies and has received approval from the food and drug administration for the treatment of early and advanced breast cancer, advanced nonsmall cell lung cancer, hormone refractory prostate cancer, advanced gastricgastroesophageal junction cancer, and locally advanced head and neck cancer. Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received docetaxel administered at 100 mgm 2 as a 1hour infusion every 3 weeks. Docetaxel is a white to almostwhite powder with an empirical formula of c 43h 53no 14 3h 2o, and a molecular weight of 861.
Treatmentrelated mortality increases with abnormal liver function, at higher doses, and in patients with nsclc and prior platinumbased therapy receiving taxotere at 100 mgm2 5. Taxol paclitaxel is obtained via a semisynthetic process from taxus baccata. Prostate cancer treatment regimens cancer therapy advisor. Highlights of prescribing information for all patients. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention see full prescribing information for complete boxed warning. Prophylactic granulocyte colony stimulating factor gcsf may be used to mitigate the risk of hematological toxicities see dosage and administration 2. May cause eye, skin, or respiratory system irritation. Taxotere is sterile, nonpyrogenic, and is available in single dose vials containing 20 mg 0.
Feb 14, 2020 docetaxel was administered in combination with cisplatin and 5fluorouracil tcf, at dose levels of 75 mgm 2 in a 1hour intravenous infusion day 1 in 28 patients aged 10 to 21 years median 16 years, 17 patients were older than 16. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Hypersensitivity to docetaxel or polysorbate 80 4 neutrophil counts of docetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Dec 12, 2019 docetaxel 75 mgm 2 every 3 weeks for 10 cycles.
This solution is readytouse and may be administered directly to the patient without further preparation. Docetaxel accord 20 mg1 ml concentrate for solution for infusion. Docetaxel accord 80 mg4 ml concentrate for solution for infusion. Docetaxel injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable nodepositive breast cancer. Initial dose of 4 mgkg as an intravenous infusion over 90 minutes then at 2 mgkg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks paclitaxel or docetaxel or 18 weeks docetaxelcarboplatin. Taxotere docetaxel injection concentrate, intravenous infusion. It is highly lipophilic and practically insoluble in water. Docetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable nodepositive breast cancer. Read all of this leaflet carefully before you start using this medicinebecause it. Docetaxel injection dose is 75 mgm2 administered 1hour after doxorubicin 50 mgm2 and cyclophosphamide 500 mgm2 every 3 weeks for 6 courses. Docetaxel injection therapy should not be given to patients with neutrophil counts of docetaxel injection see warnings and precautions 5. Follow applicable special handling and disposal procedures. Jevtana cabazitaxel injection for advanced prostate cancer.
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