Jevtana cabazitaxel injection, for intravenous use. Cabazitaxel jevtana medical clinical policy bulletins aetna. Cabazitaxel is extensively metabolised in the liver 95%, mainly by the cyp3a isoenzyme 80% to 90%. Mean cabazitaxel halflife will be plotted over time for cabazitaxel day 1, cycle 1 and cabazitaxel coadministered with enzalutamide day1, cycle 2. Compare prices, print coupons and get savings tips for jevtana cabazitaxel and other prostate cancer drugs at cvs, walgreens, and other pharmacies. Obtain frequent blood counts to monitor for neutropenia. Enzalutamide and cabazitaxel in treating patients with. To receive any information on this website in an alternate format, please contact communications by phone at.
Cabazitaxel versus docetaxel both with prednisone in patients. Cabazitaxel is an antineoplastic used with the steroid medicine prednisone. Mar 23, 2020 cabazitaxel is contraindicated in patients with neutrophil count. Set aside the jevtana injection and supplied diluent vials. Docetaxel is a widelyused secondgeneration taxane compound. Jevtana cabazitaxel injection, for intravenous use initial u. Jevtana is indicated in combination with prednisone for the treatment of patients with. Please be sure to complete this form in its entirety.
Prior to constituting ixempra for injection, the kit should be removed from the refrigerator and allowed to stand at room temperature for approximately 30 minutes. Seven metabolites were detected in plasma including 3 active metabolites issued form odemethylations, with the main one accounting for 5% of parent exposure. 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. Costeffectiveness model of abiraterone plus prednisone. Cabazitaxel requires two dilutions prior to administration. Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic.
How to access a pdf or word document large file warning. Cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Side effects of jevtana cabazitaxel injection, warnings, uses. 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. You will need to take prednisone every day during your treatment with cabazitaxel injection. Oh chekai tsao, division of hematology and medical oncology, the tisch cancer institute, icahn school of medicine at mount sinai, new york, ny, usa. 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. It is an antineoplastic agent that belongs to the taxane class. Cabazitaxel is the main circulating compound in human plasma. Cabazitaxel versus docetaxel as firstline therapy for patients.
Jevtana will be given by a drip infusion into one of your veins intravenous use in. Cabazitaxel is usually given after other cancer medicines have been tried without success. A member of the advanced prostate cancer online group recently posted about his experience using the newly approved chemotherapy agent, jevtana cabazitaxel. April 2016 nhs trusts purchase cabazitaxel in preprepared intravenousinfusion bags, not in vials, and the company provides cabazitaxel with. It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentratesolvent mixture with the intended concentration of 10 mgml cabazitaxel. 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. Tell your doctor if you have ever had an unusual or. A total of 36 aes were selected from the product inserts of 104 treatments recommended by practice guidelines.
Cancer care ontario is committed to ensuring accessible services and communications to individuals with disabilities. Neutropenia and hypersensitivity see full prescribing information for complete boxed warning. Cabazitaxel, a microtubule inhibitor, is a chemotherapeutic agent for the treatment of advanced prostate cancer. Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to.
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. Attempting to open large files over the internet within the browser window may cause problems. Cabazitaxel is administered every 21 days average of 6 cycles or until disease progression or unacceptable toxicity develops. Jevtana is usually given after other cancer medicines have been tried without success. Jevtana summary of product characteristics smpc emc. 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.
Cabazitaxel for hormonerelapsed metastatic prostate cancer. 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. Purposein patients with metastatic castrationresistant prostate cancer mcrpc, overall survival os is significantly improved with cabazitaxel. Neutropenia, anemia, thrombocytopenia, andor pancytopenia may occur. Nov 09, 2018 cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Jevtana is a nccn designated category 1 secondline therapy for mcrpc.
The jevtana injection is a clear yellow to brownishyellow viscous solution, if appropriately stored. Febrile neutropenia, diarrhea and hematuria were more frequent in the cabazitaxel 25 mgm 2 arm. Fda label information for this drug is available at dailymed. The only secondary endpoint that favored cabazitaxel was the objective response rate, which was superior for cabazitaxel 25 mgm 2 compared to docetaxel 42% vs 31%, p 0. Each ml of concentrate contains 40 mg cabazitaxel anhydrous, 1. Jevtana must be prepared diluted before it is given. Cabazitaxel to treat prostate cancer chemotherapy news. Cabazitaxel is a semisynthetic derivative of the natural taxoid 10deacetylbaccatin iii with potential antineoplastic activity. Cabazitaxel is given to shrink the tumor and decrease symptoms associated with metastatic prostate cancer. The role of cabazitaxel in the treatment of metastatic. Practical information for handling and administration of jevtana for doctors, nurses and pharmacists is provided with this leaflet.
Taxol paclitaxel is obtained via a semisynthetic process from taxus baccata. Cabazitaxel previously xrp6258, trade name jevtana is a semisynthetic derivative of a natural taxoid. Cabazitaxel is contraindicated in patients with neutrophil count. Missing information makes it difficult to approve requests and creates a longer processing time. Request pdf costeffectiveness model of abiraterone plus prednisone, cabazitaxel plus prednisone and enzalutamide for visceral metastatic. Mechanism of action and biological rationale for cabazitaxel. Cabazitaxel is metabolized in the liver primarily by cyp 3a45 isoenzymes and, to a lesser degree, by cyp2c8 enzymes. Phase i doseescalation study of cabazitaxel administered in. Cohorts of three to six patients received cabazitaxel 1520 mgm2. 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. Nccn clinical practice guidelines in oncology prostate cancer version 2. Cabazitaxel is used to treat people with prostate cancer that has progressed despite treatment with docetaxel. Jevtana 60 mg solution for injection, singledose vial.
Jevtana is contraindicated in patients with neutrophil counts of. Preparation and administration for jevtana cabazitaxel. The first taxane was paclitaxel, a drug isolated from yew tree bark in the 1960s and first approved by the fda in 1992 for treatment of refractory ovarian cancer. Primary prophylaxis with filgrastim is recommended in patients with highrisk clinical features.
Noncompartmental pharmacokinetic analysis will be performed on individual concentrationtime data to calculate halflife from 0 hours to last measurable concentration for cabazitaxel. Jan 01, 2020 cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Cabazitaxel is prepared by semisynthesis with a precursor extracted from yew needles 10deacetylbaccatin iii. Jevtana cabazitaxel dose, indications, adverse effects. For a complete listing, see the dosage forms, composition and packaging section of the product monograph. 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. Fda for the treatment of hormonerefractory prostate cancer on june 17, 2010. Cabazitaxel binds mainly to human serum albumin 82% and lipoproteins. One mans experience fighting the side effects of jevtana. When the vials are first removed from the refrigerator, a white precipitate may be observed in the diluent vial. The clinicians guide to jevtana jevtana cabazitaxel.
Indicate the full name of the medication administered including strength if applicable e. 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. Australian public assessment report for cabazitaxel. Each ml contains 40 mg cabazitaxel anhydrous and 1. Cabazitaxel uses, dmf, dossier, manufacturer, supplier. Dosage adjustment and pharmacokinetic profile of irinotecan in cancer patients. Jevtana cabazitaxel injection for advanced prostate cancer. His post included not only a report about his psa response to the drug, but his experiences with side effects and a suggested method of controlling one of the debilitating side effect, diarrhea. Contraindicated for use in pregnant women because drug can cause fetal harm and potential loss of pregnancy. Safety and pharmacokinetics of cabazitaxel in patients with hepatic. Both the cabazitaxel injection and the diluent vials contain an overfill to compensate for liquid loss during preparation.
The role of cabazitaxel in the treatment of metastatic castrationresistant prostate cancer chekai tsao, elena cutting, jacob martin, and william k. Aug, 2015 mean cabazitaxel halflife will be plotted over time for cabazitaxel day 1, cycle 1 and cabazitaxel coadministered with enzalutamide day1, cycle 2. Cabazitaxel vs docetaxel in chemotherapynaive cn patients. Cabazitaxel side effects, dosage, interactions drugs.
Cabazitaxel has not been studied in patients with hepatic impairment hi. Prednisone plus cabazitaxel or mitoxantrone for metastatic castrationresistant prostate cancer progressing after docetaxel treatment. Jevtana cabazitaxel dosing, indications, interactions. Mar 10, 2011 mechanism of action and biological rationale for cabazitaxel.
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