Taxotere package insert pdf in word

Taxotere docetaxel injection concentrate is a clear yellow to brownishyellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. 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. Use only a 21 gauge needle to withdraw taxotere from the vial because larger bore needles e. Docetaxel fda prescribing information, side effects and uses. Highlights of prescribing information these highlights do not include all the information needed to use docetaxel safely and effectively.

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. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Taxotere docetaxel dose, indications, adverse effects. Serious irreversible myocardial toxicity with delayed congestive. It may be used by itself or along with other chemotherapy medication. Call your doctor for instructions if you miss an appointment for your docetaxel injection, or if you miss a dose of your steroid medication. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and nonsmallcell lung cancer. Find patient medical information for taxotere intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. 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. Antineoplastic pregnancy risk category d fda box warning give under supervision of physician experienced in cancer chemotherapy, in facility with adequate diagnostic and treatment resources. Taxotere docetaxel injection concentrate, 20 mgml and.

Treatmentrelated death is more likely if patient has abnormal hepatic function, is. For more detail, see how taxotere works section below. The aim of this study was to characterize population pharmacokinetics and the exposureneutropenia relationship with nanoparticle albumin. Docetaxel injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior platinumbased chemotherapy. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over.

Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid. The spl will be accessible from publicly available. Data published by thiesen and kramer in 1999 suggested acceptable physicochemical stability for up to 28 days 4. 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 white to almostwhite powder with an empirical formula of c 43h 53no 14 3h 2o, and a molecular weight of 861. Taxotere docetaxel for injection side effects, images.

Docetaxel medical definition merriamwebster medical. Counseling information of the package insert, and the patient package insert ppi of taxotere labeling. 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. It does not take the place of talking to your doctor, nurse or pharmacist. Do not substitute herceptin trastuzumab for or with adotrastuzumab emtansine. Taxotere is classified as a plant alkaloid, a taxane and an antimicrotubule agent. There is an increased chance of death in patients treated with this drug who have poor liver function, are treated with higher doses, in patients with nonsmall cell lung cancer and a history of using other platinumbased chemotherapy drugs. Taxotere is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and headneck cancer. Docetaxel injection, usp requires no prior dilution with a diluent and is ready to add to the infusion solution. Docetaxel injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable nodepositive breast cancer. Each of the medications are designed to kill breast cancer cells or slow the growth of those. Docetaxel injection in combination with cisplatin is indicated for the treatment of patients with. As a type of chemotherapy, taxotere is used to kill cancer cells affecting the breast, prostate, or lung. It is highly lipophilic and practically insoluble in water.

The 1vial taxotere, now at 20mgml concentration, is ready to be added directly into the infusion solution. Adriamycin must not be given by the intramuscular or subcutaneous route. This emedtv article offers a more indepth look at taxotere and its specific uses, side effects, and information on how the medication is given. Taxol is the first of a new class of anticancer agents known as taxanes. Taxotere patient information including if i miss a dose. Taxol contains paclitaxel, a natural product with antitumour activity. May cause damage to organs through prolonged or repeated exposure. Click the orange links and well show you extra information. The fda rejected the request, noting that taxotere was more toxic than its competing drug taxol already approved by the fda and that more research into taxoteres side effects was needed.

The schmidt firm, pllc is currently accepting taxotere induced injury cases in all 50 states. Taxotere definition of taxotere by medical dictionary. Taxotere docetaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Docetaxel injection as a single agent is indicated for the treatment of patients with locally. This emedtv article takes a closer look at taxoteres effects on the body and explains how it works to treat cancer. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Taxotere injection 20 mgml requires no prior dilution with a diluent and is ready to add to the infusion solution. Severe local tissue necrosis will occur if there is extravasation during administration.

Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer. Docetaxel clinical pharmacology mechanism of action. Taxotere has a significant risk of longterm alopecia. Sanofi initially sought food and drug administration fda approval for taxotere in 1994. Taxotere in combination with cisplatin and fluorouracil is indicated for the treatment of. One would think that a roughly 3% chance of developing permanent hair loss should have been significant enough to warrant at least some mention on taxoteres label right from the start. Highlights of prescribing information initial dose of. Taxotere is an anticancer antineoplastic or cytotoxic chemotherapy drug. Taxotere is sterile, nonpyrogenic, and is available in.

Taxotere in combination with prednisone is indicated for the treatment of patients with androgen independent hormone refractory metastatic prostate cancer. Dailymed docetaxel docetaxel anhydrous injection, solution. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. Docetaxel injection, for intravenous use initial u. Taxotere in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease. Pronunciation of taxotere with 2 audio pronunciations and more for taxotere. Approved in treatment of breast cancer, nonsmall cell lung cancer, advanced stomach cancer, head and neck cancer. Taxotere is a drug that is approved to treat breast cancer, prostate cancer, and other types of cancer. Taxotere docetaxel injection concentrate, intravenous infusion iv is an antineoplastic anticancer agent used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and headneck cancer what are side effects of taxotere. Prophylactic gcsf may be used to mitigate the risk of hematological toxicities see dosage and administration 2. With 1vial taxotere, the pharmaceutical ingredients of taxotere and the one hour iv infusion administration to the patient remain the same. Taxotere 20 mgml concentrate solution for injection, singleuse.

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