To demonstrate the superiority of cabazitaxel plus prednisone at 25 mgm2 arm a or 20 mgm2 arm b versus docetaxel plus prednisone arm c in term of overall survival os in participants with metastatic castration resistant prostate cancer mcrpc and not previously treated with chemotherapy. Treatment with cabazitaxel was prognostic for survival. Cancer cells that express pgp become resistant to taxanes, and the effectiveness of docetaxel can be limited by its high substrate affinity for pgp. Jevtana will be given by a drip infusion into one of your veins intravenous use in. The pdf file should be the first option within the insert dialog window. Side effects of jevtana cabazitaxel injection, warnings, uses. Cabazitaxel versus docetaxel both with prednisone in patients with metastatic castration resistant prostate cancer firstana the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Jevtana cabazitaxel injection, for intravenous use initial u. This article also provides some important tips about when and how to receive your infusion. Cabazitaxel is a novel tubulinbinding taxane that differs from docetaxel because of its poor affinity for pglycoprotein pgp, an atpdependent drug efflux pump. The prostate is a gland that is sized and shaped like a walnut, which is found in a mans reproductive system and located below the bladder, near the rectum and around the urethra. Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to.
Cabazitaxel is metabolized in the liver primarily by cyp 3a45 isoenzymes and, to a lesser degree, by cyp2c8 enzymes. Cabazitaxel binds to and stabilizes tubulin, resulting in the inhibition of microtubule depolymerization and cell division, cell cycle arrest in the g2m phase, and the inhibition of tumor cell proliferation. Jevtana is indicated in combination with prednisone for the treatment of patients with. Fda label information for this drug is available at dailymed. Cabazitaxel patients were pretreated with a single dose of iv antihistamine, corticosteroids 8 mg dexamethasone or equivalent and h2 antagonist except cimetidine 30 minutes before cabazitaxel. Insert pdf file content into a powerpoint presentation. Toxicity management was followed as described in the prescribing information document on cabazitaxel.
Call your doctor for medical advice about side effects. Treatment was repeated every 21 days for a maximum of 10 cycles. In these studies, cabazitaxel was given at a dosage of 25 mgm. It is prepared by semisynthesis with a precursor extracted from yew needles. Cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. People receiving cabazitaxel should be aware that the drug can cause infections and other serious problems. In the insert object box, select create from file, and then enter the pdf file location. Several trials have tried to enhance the antitumor activity of cabazitaxel by adding a second agent with a distinct mechanism of action. One patient experienced a grade 1 allergic reaction and the other grade 3 hives. Each ml of concentrate contains 40 mg cabazitaxel anhydrous, 1. Cabazitaxel was used according to the summary of product characteristics. Click the image and it will be inserted into the slide. Learn about jevtana, a nccn designated category 1 secondline therapy for patients with metastatic castrationresistant prostate cancer mcrpc previously treated with a docetaxelcontaining regimen. Cabazitaxel is approved to be used with prednisone to treat prostate cancer that has metastasized spread to other parts of the body in men whose cancer is castration resistant has not responded to treatments that lower testosterone levels and who have already been treated with chemotherapy that included docetaxel.
Unfortunately, use of the drug was limited for many patients due to. Obtain frequent blood counts to monitor for neutropenia. The jevtana injection is a clear yellow to brownishyellow viscous solution, if appropriately stored. Jevtana is contraindicated in patients with neutrophil counts of. It was described as clearly a major advance in secondary chemotherapy for advanced. Cabazitaxel side effects, dosage, interactions drugs. No formal pharmacokinetic studies were conducted with cabazitaxel in patients with renal. This is not a complete list of side effects and others may occur. Cabazitaxel is usually given after other cancer medicines have been tried without success.
Cabazitaxel is a semisynthetic derivative of the natural taxoid 10deacetylbaccatin iii with potential antineoplastic activity. Mean cabazitaxel halflife will be plotted over time for cabazitaxel day 1, cycle 1 and cabazitaxel coadministered with enzalutamide day1, cycle 2. Cabazitaxel with prednisone is commonly given with the goal of improving survival in men with prostate cancer, but usually not with the goal of cure. Jevtana cabazitaxel injection, for intravenous use. Cabazitaxel is given to shrink the tumor and decrease symptoms associated with metastatic prostate cancer. Jevtana is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic. This emedtv segment explains that the guidelines for dosing with cabazitaxel will vary for each person, depending on things such as your body surface area. Food and drug administration fda and european medicines agency approval as a therapy for patients with metastatic hormoneresistant prostate cancer mhrpc previously treated with a docetaxelcontaining regimen package insert, jevtana sanofi.
Jevtana cabazitaxel dosing, indications, interactions. Firstline all among 58 oncaspartreated patients enrolled in study 1, clinical allergic reactions were reported in 2 patients 3%. Cabazitaxel is the main circulating compound in human plasma. Jevtana cabazitaxel injection for advanced prostate cancer. Cabazitaxel for metastatic castrationresistant prostate cancer. For a complete listing, see the dosage forms, composition and packaging section of the product monograph. Cabazitaxel drug monograph pharmacy benefit management. To determine the efficacy and safety of cabazitaxel in metastatic. Cabazitaxel is minimally excreted via the kidney 2. Set aside the jevtana injection and supplied diluent vials. Cabazitaxel to treat prostate cancer chemotherapy news. It was developed by sanofiaventis and was approved by the u. This emedtv article lists other important precautions and warnings with cabazitaxel and explains why the drug is not suitable for some people. Cancer care ontario is committed to ensuring accessible services and communications to individuals with disabilities.
It is an antineoplastic agent that belongs to the taxane class. Impact of cabazitaxel on 2year survival and palliation of tumour. Nccn clinical practice guidelines in oncology prostate cancer version 2. Cancer cells that express pgp become resistant to taxanes, and the effectiveness. Fda for the treatment of hormonerefractory prostate cancer on june 17, 2010. Cabazitaxel is extensively metabolised in the liver 95%, mainly by the cyp3a isoenzyme 80% to 90%. Cabazitaxel injection comes as a liquid to be given intravenously into a vein over 1 hour by a doctor or nurse in a medical facility. Our jevtana cabazitaxel side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Patients receiving concomitant capecitabine and oral coumarin. Jevtana cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body jevtana is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic jevtana is usually given after other cancer medicines have been tried without success.
Jevtana will be given by a drip infusion into one of your veins intravenous use in hospital for about an hour. Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic cabazitaxel is usually given after other cancer medicines have been tried without success. The quality of the pdf file is reduced with this method, but you can open the full pdf file by doubleclicking the image when viewing or editing in normal view. Cabazitaxel for hormonerelapsed metastatic prostate. Cabazitaxel is a secondgeneration taxane that exhibited cytotoxic activity against a broad range of cancer cell lines and tumor models with greater potency than docetaxel in multidrugresistant tumor cells, prompting its development as an agent to overcome docetaxel resistance, perhaps because of its weaker binding affinity to pglycoprotein.
The patient has castrationresistant metastatic prostate cancer and. Download figure open in new tab download powerpoint. Jevtana must be prepared diluted before it is given. Side effects of jevtana cabazitaxel injection, warnings. Jun 11, 2018 jevtana must be prepared diluted before it is given. Mar 10, 2011 cabazitaxel is a novel tubulinbinding taxane that differs from docetaxel because of its poor affinity for pglycoprotein pgp, an atpdependent drug efflux pump. Cabazitaxel is the first chemotherapy to have shown a survival benefit in this setting since docetaxel. In firstana, cabazitaxel and docetaxel were compared in a headtohead randomized trial designed to show superiority of cabazitaxel over docetaxel with respect to overall survival. It is a microtubule inhibitor, and the fourth taxane to be approved as a cancer therapy. Jevtana 60 mg solution for injection, singledose vial. The prostate is a gland that is sized and shaped like a walnut, which is found in a mans reproductive system and located below the bladder.
Final appraisal determination cabazitaxel for hormone relapsed metastatic prostate cancer treated with docetaxel issue date. Contraindicated for use in pregnant women because drug can cause fetal harm and potential loss of pregnancy. To receive any information on this website in an alternate format, please contact communications by phone at. Jevtana cabazitaxel injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. Noncompartmental pharmacokinetic analysis will be performed on individual concentrationtime data to calculate halflife from 0 hours to last measurable concentration for cabazitaxel. Practical information for handling and administration of jevtana for doctors, nurses and pharmacists is provided with this leaflet. Jevtana is usually given after other cancer medicines have been tried without success. Firstline chemotherapy for metastatic castrationresistant prostate cancer mcrpc with docetaxel d every 3 weeks plus prednisone yields a median overall survival os of nearly 19 months. Clinical concepts for cabazitaxel in the management of metastatic. Cabazitaxel previously xrp6258, trade name jevtana is a semisynthetic derivative of a natural taxoid. The recommended dose of jevtana is based on calculation of the body surface area bsa, and is administered as a onehour intravenous infusion every. It is prepared by semisynthesis with a precursor extracted from yew needles the chemical name of cabazitaxel is 2. Please be sure to complete this form in its entirety.
Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic. Patients had their luteinising hormonereleasing hormone lhrh agonist therapy continued. Seven metabolites were detected in plasma including 3 active metabolites issued form odemethylations, with the main one accounting for 5% of parent exposure. Cabazitaxel versus docetaxel both with prednisone in patients. Jevtana cabazitaxel 215000030020 antimicrotubular criteria for coveragenoncoverage jevtana cabazitaxel will be considered for coverage under the pharmacy benefit program when the following criteria are met. Xelodawarfarin interaction xeloda warfarin interaction. April 2016 nhs trusts purchase cabazitaxel in preprepared intravenousinfusion bags, not in vials, and the company provides cabazitaxel with the discount agreed in the patient access scheme. Sequencing of cabazitaxel and abiraterone acetate after. Enzalutamide and cabazitaxel in treating patients with. The pharmacokinetics of cabazitaxel showed doseproportional drug exposure.
You will need to take prednisone every day during your treatment with cabazitaxel injection. Aug, 2015 mean cabazitaxel halflife will be plotted over time for cabazitaxel day 1, cycle 1 and cabazitaxel coadministered with enzalutamide day1, cycle 2. Each ml contains 40 mg cabazitaxel anhydrous and 1. Crossover to cabazitaxel was not allowed for the mitoxantrone group. Cabazitaxel in metastatic castrationresistant prostate cancer. Tell your doctor if you have ever had an unusual or. Indicate the full name of the medication administered including strength if applicable e. Missing information makes it difficult to approve requests and creates a longer processing time. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are. It is important that you take prednisone exactly as prescribed by your doctor. Jevtana is a nccn designated category 1 secondline therapy for mcrpc.
Taxotere docetaxel injection concentrate, intravenous infusion iv prescribing information. 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. Jevtana cabazitaxel is a chemotherapy drug used to treat prostate cancer, a disease that occurs when cells in the prostate start to grow out of control. Jan 01, 2020 cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Based on the results of the tropic trial, cabazitaxel 25 mgm 2 has been fdaapproved since 2010 specifically for metastatic crpc patients who have already received prior docetaxel chemotherapy. Cabazitaxel binds mainly to human serum albumin 82% and lipoproteins. Jevtana summary of product characteristics smpc emc. Preparation and administration for jevtana cabazitaxel. Nov 09, 2018 cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. April 2016 nhs trusts purchase cabazitaxel in preprepared intravenousinfusion bags, not in vials, and the company provides cabazitaxel with. Cabazitaxel, a microtubule inhibitor, is a chemotherapeutic agent for the treatment of advanced prostate cancer. Listing a study does not mean it has been evaluated by the u. Jan 22, 2020 jevtana cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Cabazitaxel jevtana medical clinical policy bulletins aetna.
Mar 24, 2020 jevtana cabazitaxel is a cancer antineoplastic medication used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic. See important safety information and full prescribing information, including boxed warning. Jevtana is a prescription anticancer medicine used with the steroid medicine prednisone. Neutropenia and hypersensitivity see full prescribing information for complete boxed warning.
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