Confidential page 1 of 53 highlights of prescribing information. For the 2 x 5 ml syringe package, the contents of both syringes must be injected to receive the 500 mg. Highlights of prescribing information for all patients. The use of granulocyte colonystimulating factors was 42% in cyramza with docetaxel treated patients versus 37% in patients who received placebo with docetaxel.
Sequential intravesical gemcitabine and docetaxel for the. It is a signal which warns that the intravenous chemotherapy drug docetaxel contains ethanol. Taxotere is sterile, nonpyrogenic, and is available in. Learn about jevtana, a nccn designated category 1 secondline therapy for patients with metastatic castrationresistant prostate cancer mcrpc previously treated with a docetaxel containing regimen. Information for the patient docetaxel accord 20 mg1 ml concentrate for solution for infusion docetaxel accord 80 mg4 ml concentrate for solution for infusion docetaxel accord 160 mg8 ml concentrate for solution for infusion docetaxel. Chemotherapy dosing in the setting of liver dysfunction. This solution is readytouse and may be administered directly to the patient without further preparation. These side effects may be more severe when taxotere is used with other cancer medicines. Docetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. The vinorelbine package insert empirically recommends reducing the vinorelbine dose by 50% for serum bilirubin levels of 2.
Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. In combination with docetaxel, the recommended dose of xeloda is 1250 mgm2 twice daily for 2 weeks followed by a 7day rest period, combined with docetaxel at 75 mgm2 as a 1hour iv infusion every 3 weeks 2. Docetaxel injection as a single agent is indicated for the treatment of patients with locally. Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
See full prescribing information for complete boxed warning. 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. Select patients for therapy based on an fdaapproved companion diagnostic for trastuzumab see dosage and administration 2. For patients who are dosed initially at taxotere 75 mgm 2 in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is taxotere dosage in subsequent cycles should be. Locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy. Docetaxel is administered as a onehour infusion every three weeks. Jevtana is a prescription medicine used with the steroid medicine prednisone to treat men with prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has worsened after treatment with other medicines, including docetaxel.
Breast cancer in the adjuvant treatment of operable nodepositive and nodenegative breast cancer, the recommended dose of docetaxel is 75 mgm2 administered 1hour after doxorubicin 50 mgm2 and. Taxotere as a single agent is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure. 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 fda prescribing information, side effects and uses. Docetaxel injection this product information is intended only for residents of the united states. For the full list of side effects of taxotere, see the package leaflet. These highlights do not include all the information needed to use aloxi safely and effectively. Docetaxel injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable nodepositive breast cancer. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution.
This document provides specific information to each section of the overall policy. Contraindications to prednisone also apply to the combination with taxotere please refer to product monograph for prednisone. Taxotere must not be used in patients who have a neutrophil count of less than 1,500 cellsmm3 or who have severe problems with their liver. Jevtana is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castrationresistant prostate cancer previously treated with a docetaxel containing treatment regimen.
Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable nodepositive breast cancer. During and following paclitaxel, docetaxel, or docetaxel carboplatin. Pharmacokinetic optimization of docetaxel dosing frederike engels. Prophylactic granulocyte colony stimulating factor gcsf may be used to mitigate the risk of hematological toxicities see dosage and administration 2. Low white blood cells, which can cause you to get serious infections, and may lead to death. Taxotere is sterile, nonpyrogenic, and is available in single dose vials containing 20 mg 0. In combination with docetaxel after failure of prior anthracyclinecontaining therapy. See important safety information and full prescribing information, including boxed warning. Taxotere docetaxel dose, indications, adverse effects. Men who are 65 years or older may be more likely to have these problems. For capecitabine dose modifications, see capecitabine summary of product. Taxotere and american taxotere with hospira docetaxel injection. Highlights of prescribing information initial dose of.
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. Dacogen decitabine for injection description dacogen decitabine for injection contains decitabine 5aza2deoxycytidine, an analogue of the natural nucleoside 2deoxycytidine. Refer to the manufacturer package insert for specific instructions. Highlights of prescribing information initial dose of 4. The active substance in docetaxel accord, docetaxel, belongs to the group of cancer medicines known as taxanes. Taxotere docetaxel injection concentrate, intravenous infusion. Due to the potential for serious adverse reactions in nursing infants from docetaxel, advise women to discontinue breastfeeding during treatment and for 1 to 2 weeks after the final dose. Dailymed docetaxel docetaxel anhydrous injection, solution. Docetaxel injection, usp is a sterile, nonpyrogenic, clear, colorless to pale yellow solution at. Taxotere dose is 75 mgm2 administered 1 hour after doxorubicin 50 mgm2 and cyclophosphamide 500 mgm2 every 3 weeks for 6 courses. The labelling and package leaflet were amended accordingly. It is highly lipophilic and practically insoluble in water. Prophylactic gcsf may be used to mitigate the risk of hematological toxicities see dosage and administration 2.
Patients were treated with 6 weekly instillations of gemcitabine 1 gram of gemcitabine in 50 ml of sterile water followed immediately by docetaxel 37. Cytoxan cyclophosphamide for injection, usp cytoxan. Treatmentrelated mortality increases with abnormal liver function, at higher doses, and in patients with nsclc and prior platinumbased therapy receiving docetaxel at 100 mgm2 5. It is a cardioprotective agent for use in conjunction with doxorubicin. Breast cancer in the adjuvant treatment of operable nodepositive and nodenegative breast cancer, the recommended dose of docetaxel is 75 mgm2 administered 1hour after doxorubicin 50 mgm2 and cyclophosphamide. You are encouraged to report negative side effects of medical devices or prescription drugs to the fda. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Docetaxel is a white to almostwhite powder with an empirical formula of c 43h 53no 14 3h 2o, and a molecular weight of 861. Taxotere docetaxel injection concentrate is a clear yellow to brownishyellow viscous solution.
Page 5 of 62 contraindications to doxorubicin and cyclophosphamide also apply to their combination. Docetaxel injection dose is 75 mgm2 administered 1hour after doxorubicin 50 mgm2 and cyclophosphamide 500 mgm2 every 3 weeks for 6 courses. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Taxotere in combination with cisplatin and fluorouracil is indicated for the treatment of. Taxotere monotherapy is indicated for the treatment of patients with locally. Abraxane is indicated for the firstline treatment of locally advanced or metastatic nonsmall cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Taxotere in combination with prednisone is indicated for the treatment of patients with androgen independent hormone refractory metastatic prostate cancer. Taxotere procedural steps taken and scientific information after the authorisation application number scope opinion notification1 issued on 2. Starting and staying on track with jevtana important safety information jevtana may cause serious side effects, including.
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