Assessment report for zytiga abiraterone procedure no. The safety of these increased exposures when multiple doses of abiraterone acetate. Special pediatric considerations are noted when applicable, otherwise adult provisions apply. Abiraterone acetate for early stage metastatic prostate. Download pdf of prescribing information for abiraterone acetate. Abiraterone acetate abiraterone or zytiga is a hormonal therapy drug used to treat advanced prostate cancer. Avoid coadministration with cyp2d6 substrates with a narrow therapeutic index. Abiraterone for prostate cancer not previously treated. Highlights of prescribing information these highlights do. It is best to read this information with our general information about hormonal therapies and the type of cancer you have.
Abiraterone acetate is designed to treat these tumors by inhibiting the production of androgen in the testes, adrenal glands, and prostate cancer tumors themselves. Abiraterone acetate zytiga, janssen biotech is a new cytochrome p450 cyp 17 inhibitor that was approved by the fda in 2011 in combination with prednisone for crpc in patients who have received prior docetaxel chemotherapy. Patient information zytiga zye ga abiraterone acetate. Abiraterone improves survival in metastatic prostate. Abiraterone acetate has been identified or labeled to communicate a risk of reproductive harm developmental, female, and male endpoints. Targets cyp17 ic50 72 nm 1 in vitro abiraterone shows a good complexation with the heme iron only in sm1. You may not use the abiraterone acetate instant savings program if you are uninsured or have no prescription drug coverage for abiraterone acetate. Pdf abiraterone and increased survival in metastatic prostate. Dose and schedule taking abiraterone acetate as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember.
The applicant requested the active substance abiraterone acetate contained in the above medicinal product to be considered as a new active substance in itself. Pdf abiraterone acetate in castrationresistant prostate. Updated guidelines for metastatic hormonesensitive. Optimal sequencing of enzalutamide and abiraterone acetate. Abiraterone acetate in castrationresistant prostate cancer. A study of abiraterone acetate plus lowdose prednisone. Check with your pharmacist if you have questions about the best way to throw out drugs. Abiraterone acetate in the treatment of metastatic castrationresistant. Only select registry of toxic effects of chemical substances rtecs data is presented here. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs. Impact of abiraterone acetate in prostatespecific antigen the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. See actual entry in rtecs for complete information. Zytiga in combination with prednisone is indicated for the treatment of patients with metastatic castrationresistant prostate cancer crpc who have received. Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, which inhibits 17.
Read the patient information leaflet if available from your pharmacist before you start taking abiraterone and each time you get a refill. Des discrete event simulation, aap abiraterone acetate in combination with prednisone. Studies were performed to assess the potential inhibition of cyp2c8 by abiraterone acetate, to characterise the mechanism by which resistance to abiraterone acetate is developed and to characterise impurity r601250. Zytiga tablets contain either 250 mg or 500 mg of abiraterone acetate.
Abiraterone acetate is a prodrug that is converted in vivo to abiraterone. Abiraterone acetate is a cyp17 inhibitor that is sold in 500 mg and 250 mg coated tablets and 250 mg uncoated tablets. It is given with steroid tablets and sometimes with other types of hormonal therapy drugs. Abiraterone acetate is rapidly hydrolyzed to abiraterone by esterases, then.
Zytiga is used to treat men with prostate cancer that has spread to other parts of the body it is not known if zytiga is safe and effective in females or children. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with. Abiraterone acetate is a selective, irreversible inhibitor of cyp17, an enzyme that is critical in the production of androgens in the testes, adrenal glands, and prostatetumor tissue. Check with your pharmacist if you have questions about the. Abiraterone acetate tablets definition abiraterone acetate tablets contain nlt 90. Abiraterone acetate zytiga, janssen biotech is a new cytochrome p450 cyp 17 inhibitor that was approved by the fda in 2011 in combination with prednisone for crpc in patients who have received. Abiraterone and increased survival in metastatic prostate cancer. Abiraterone presented as 500mg tablets since formulation switch in 2017. It is also being studied in patients with earlierstage prostate cancer and in women with metastatic breast cancer. Abiraterone for prostate cancer not previously treated with. The combination of abiraterone acetate plus prednisone with adt was associated with significantly longer overall survival than placebos plus adt in men with newly diagnosed highrisk mcspc and had a manageable safety profile. Abiraterone acetate is converted, in vivo, to abiraterone. Antitumour activity and safety of enzalutamide in patients with metastatic castrationresistant prostate cancer previously treated with abiraterone acetate plus. Abiraterone acetate cb7630, cb 7630, cb7630 is an acetate salt form of abiraterone which is a steroidal cytochrome cyp17 inhibitor with ic50 of 72 nm.
Abiraterone acetate plus prednisone in patients with newly. Abiraterone blocks the production of testosterone which helps slow down the growth of the cancer. These findings support the use of abiraterone acetate. Abiraterone acetate is a selective, irreversible inhibitor of cyp17, an enzyme that is critical in the. Abiraterone acetate plus prednisolone improves survival in men with. Abiraterone acetate is a semisynthetic steroid with multiple chiral centres figure 1, all of which are controlled so that abiraterone acetate is a single stereoisomer. Zytiga pharmacokinetics absorption bioavailability. Australian public assessment report for abiraterone acetate. For both indications, patients take mg of abiraterone acetate once daily along with 5 mg of prednisone twice daily. Abiraterone acetate for early stage metastatic prostate cancer. Abiraterone, also known as abiraterone acetate and sold under the brand name zytiga among others, is a medication used to treat prostate cancer.
Zytiga abiraterone acetate is a prescription medicine that is used along with prednisone. Abiraterone acetate tablets are a cyp17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castrationresistant prostate cancer crpc. Prescription treatment with zytiga abiraterone acetate. Zytiga abiraterone acetate tablets 1 highlights of. Do not flush down a toilet or pour down a drain unless you are told to do so.
Abiraterone acetate aa, after metabolization to abiraterone, is an oral inhibitor of the cytochrome p450c17. Abiraterone acetate zytiga macmillan cancer support. Abiraterone zytiga, a novel agent for the management of. Each tablet contains 250 mg of abiraterone acetate. Specifically it is used together with corticosteroid for. Each 250 mg tablet contains 189 mg of lactose and 6. Updated guidelines for metastatic hormonesensitive prostate cancer.
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