If toxicity recurred after drug rechallenge, and further interruptions were considered insufficient to manage the toxicity, gefitinib discontinuation. Docetaxel fda prescribing information, side effects and uses. Repurposing screen identifies mebendazole as a clinical candidate. Effects on quality of life of weekly docetaxelbased chemotherapy in. Docetaxel is a chemotherapy drug described by the national cancer institute nci drug dictionary as a semisynthetic, secondgeneration taxane derived from a. This phase iii study was designed to evaluate the potential benefits of adding docetaxel to s1 without a platinum compound in patients with advanced gastric cancer. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic nonsmall cell lung cancer who have not previously received chemotherapy for this condition. Five fatal cases of neutropenic enterocolitis associated with a generic version of docetaxel have led one cancer centre to swap the drug for paclitaxel. A healthcare provider will give you this injection. A phase i study of liposomalencapsulated docetaxel ledt. 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.
The present study focuses on adjuvant docetaxel in reallife breast cancer. Initially, the unilateral thigh pain and swelling in a patient undergoing. Docetaxel injection, for intravenous use initial u. Infiltration into lymphatic vessels is a critical step in breast cancer metastasis.
Food and drug administration fda has approved a new onevial formulation of its chemotherapeutic agent. Docetaxel was previously available as a twovial formulation which included two vials a concentrated docetaxel vial and a diluent vial, resulting in a reconstituted concentration of 10 mgml. Docetaxel kabi 20 mg1 ml concentrate for solution for infusion docetaxel. Breast cancer, docetaxel resistance, taxane, exome sequencing. The mean pi for the triplicate wells containing library drugs and docetaxel had to be greater than the mean pi of docetaxelalone wells by 10%. Ndc 7248521504, singleuse vial individually packaged in a carton. Docetaxel facilitates lymphatictumor crosstalk to promote. Docetaxel alone or in combination with vaccine to treat.
Trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastroesophageal adenocarcinoma, j clin oncol, 2005, 2324. Pdf evidence for the conversion of docetaxel into 7. Docetaxel or pemetrexed with cisplatin achieve comparable. Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Fatal neutropenic enterocolitis with docetaxel in france. Docefrez docetaxel side effects, images, uses, dosage. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for taxotere docetaxel skip to. The recommended dose of jevtana is based on calculation of the body surface area bsa, and is 20 mgm. This chemotherapeutic agent is approved for the treatment of multiple. Aseptically withdraw the required amount of docetaxel injection solution 10 mg docetaxelml with a calibrated syringe and inject as a single injection into a 250 ml infusion bag or. Can cancer patients really get drunk from docetaxel. See full prescribing information for docetaxel injection. Docetaxel is an antineoplastic agent used to treat breast cancer and nonsmall cell. The first direct comparison of treating nonsquamous lung cancer with either pemetrexed or docetaxel in addition to cisplatin has shown that the two combinations achieve similar progression.
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. Addition of docetaxel to s1 without platinum prolongs. In metastatic breast cancer, weekly docetaxel as single agent was active. Docetaxel injection this product information is intended only for residents of the united states. Docetaxel is a semisynthetic microtubule disrupting anticancer drug indicated for the treatment of breast, prostate, nonsmallcell lung, head and neck, and gastric cancers 17. Lymphatics undergo changes that facilitate metastasis as a result of activation of the cells lining lymphatic. Intravenous chemotherapy drugs are dosed based on a patients. Cytoxan cyclophosphamide for injection, usp cytoxan.
Docetaxel accord 20 mg1 ml concentrate for solution for infusion docetaxel accord 80 mg4 ml concentrate for solution for infusion docetaxel accord 160. Since 2005 this is, to our knowledge, the fifth reported case of docetaxel related inflammatory. The anticancer drug docetaxel taxotere is formulated in the nonionic surfactant polysorbate 80 tween 80. Docetaxel alone or in combination with vaccine to treat breast cancer the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Phase ii study of gefitinib in combination with docetaxel as firstline. Docetaxel injection, usp is a sterile, nonpyrogenic, clear, colorless to pale yellow solution at 10 mgml concentration. Teikoku pharma usa and eagle pharmaceuticals enter into. 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. Schothorst kl, schmitz pi, bokma hj, verweij j, seynaeve c, dutch. It is a natural carrier of endogenous hydrophobic molecules. Toxicities associated with docetaxelbased regimens in the. Docetaxel can be harmful if it gets on your skin during an iv infusion. Highlights of prescribing information these highlights do not include all the information needed to use.
The value of pediatric clearance in the section 12. Albuminbound paclitaxel abi007 albumin has a number of characteristics that make it an attractive drug vehicle in oncology. Docetaxel injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable nodepositive breast cancer. Early in the clinical development of docetaxel, it became clear that docetaxel administration is. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and.
As an example, hospira sells three sizes of docetaxel, but the solution is a constant 10 milligrams of docetaxel per milliliter. Dailymed docetaxel docetaxel anhydrous injection, solution. Gemcitabine is a nucleoside analog that inhibits cell growth by incorporating into dna and prohibiting dna polymerases. Read all of this leaflet carefully before you start using this medicine because it. Docetaxel injection is an antineoplastic agent intended for the treatment of breast cancer, nonsmall cell lung cancer nsclc, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Taxotere docetaxel injection concentrate, intravenous infusion iv initial u. Docetaxel name of proposed course of treatment include brief explanation if medical term not clear docetaxel chemotherapy for the.
As with paclitaxel, the vehicle of docetaxel polysorbate 80 has also been reported to cause hypersensitivity reaction in dogs, the clinical formulation also contains ethanol, and docetaxel. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic nonsmall cell lung cancer who have not previously received chemo. Jevtana is a cytotoxic anticancer drug and caution should be exercised when handling and preparing jevtana solutions, taking into account the use of containment devices, personal protective equipment e. 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 nonalcohol formula docetaxel injection eagle pharmaceuticals, inc.
Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. The stepwise evolution of the exome during acquisition of docetaxel. Click here for typical product data set taxotere, tertbutyl14 c mor pure delivered. Docetaxel is a drug used to treat certain types of cancer. Antimultiple myeloma set domaincontaining protein, antinuclear set domaincontaining protein 2, antiprobable histonelysine nmethyltransferase nsd2, antiprotein trithorax5, antiwolf. In all patients, weakness abated after 1 to 2 months of drug cessation. Docetaxel accord docetaxel package leaflet l01cd02. See full prescribing information for complete boxed warning. It is highly lipophilic and practically insoluble in water. The primary objective was to define the maximum tolerated dose mtd and doselimiting toxicity dlt of iv docetaxel and ip oxaliplatin in women with recurrent ovarian ov, fallopian tube ft or. Docetaxel is available under the trade name taxotere. Taxotere as a single agent is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior platinum. Retain in the original package to protect from light. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are.
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