In a cyp2c8 drug interaction trial in healthy subjects, the auc of pioglitazone, a. Enzalutamide is known as an antiandrogen and it works by blocking androgen receptors so that androgens, such as testosterone, cannot bind to the receptor which prevents it from stimulating the cancer. Dosage may be reduced, delayed or discontinued in patients with bone marrow. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Prevail trial primary endpoints xtandi enzalutamide. Enzalutamide demonstrated a significant improvement in the primary endpoint of overall survival os with a hazard ratio hr of 0. Enzalutamide is an androgen receptor inhibitor which acts at several steps in the androgen receptor signaling pathway. Enzalutamide for metastatic hormone relapsed prostate cancer. Medlineplus information on enzalutamide a lay language summary of important information about this drug that may include the following. Xtandi is contraindicated for use in pregnant women because the drug can cause fetal harm and potential.
Take your prescribed dose once a day, at the same time each day. In vitro, nilutamide blocks the effects of testosterone at the androgen receptor level. This product information was approved at the time this auspar was published. Xtandi is indicated for the treatment of patients with castrationresistant prostate cancer. Xtandi 40mg soft capsules patient information leaflet pil. Restricted access do not disseminate or copy without approval. Highlights of prescribing information posterior reversible. To speak with a dedicated access specialist, please call us at 18558xtandi 18558982634. Xtandi is a prescription medicine used to treat men with prostate cancer that. Have a history of seizures, brain injury, stroke, or brain tumors. Patient information xtandi ex tan dee enzalutamide. Enzalutamide xtandi enzalutamide is a type of hormone therapy. Patients with rare hereditary problems of fructose intolerance. In some cases, health care professionals may use the trade name xtandi when referring to the generic drug name enzalutamide.
Have a history of heart disease, have high blood pressure, or have abnormal amounts of fat or cholesterol in your blood. The other ingredients of the soft capsule are caprylocaproyl macrogol8 glycerides, butylhydroxyanisole e320, and butylhydroxytoluene e321. Product monograph euflex flutamide 250 mg tablets therapeutic classification nonsteroidal antiandrogen action and clinical pharmacology flutamide demonstrates potent antiandrogenic effects by inhibiting androgen uptake andor inhibiting nuclear binding of androgen in target tissues. If the file has been modified from its original state, some details may not fully reflect the. Advanced prostate cancer treatment xtandi enzalutamide. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer terrain. Enzalutamide, sold under the brand name xtandi, is a nonsteroidal antiandrogen nsaa medication which is used in the treatment of prostate cancer. Tell your doctor about all your medical conditions, including if you. It is indicated for use in conjunction with castration in the treatment of metastatic castrationresistant prostate cancer mcrpc, nonmetastatic castrationresistant prostate cancer, and metastatic castrationsensitive prostate cancer mcspc. It is a treatment for prostate cancer that has spread to other parts of the body advanced prostate cancer. Patient information xtandi ex tan dee enzalutamide capsules what is xtandi. Under conditions of clinical use, enzalutamide is a strong inducer of cyp3a4, a moderate.
The trial was designed to evaluate patients who were randomized 1. An update on enzalutamide in the treatment of prostate cancer. Enzalutamide xtandi for prostate cancer chemoexperts. Product information for auspar xtandi enzalutamide astellas pharma australia pty ltd pm20115514 date of finalisation 24 november 2014. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for xtandi enzalutamide. Xtandi enzalutamide 40 mg capsules are supplied as white to offwhite oblong soft gelatin capsules imprinted in black ink with enz. Avoid coadministration with cyp2d6 substrates with a narrow therapeutic index. Take your prescribed dose as soon as you remember that day. The main findings of this trial have been well reported and hence are covered only briefly here saad, 20. Definition from the nci drug dictionary detailed scientific definition and other names for this drug.
Xtandi ex tan dee enzalutamide capsules what is xtandi. 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. Enzalutamide competitively inhibits binding of androgens to. Pdf emerging mechanisms of enzalutamide resistance in. A profile of enzalutamide for the treatment of advanced. Niosh list of antineoplastic and other hazardous drugs in. Enzalutamide cancer information cancer research uk.
In vivo, nilutamide interacts with the androgen receptor and prevents the normal androgenic response. Food and drug administration fda approved a supplemental new drug application snda to update the u. Mdv3100, known as enzalutamide, is a secondgeneration androgen receptor ar signaling inhibitor. An improved and practical synthesis of enzalutamide was accomplished in five steps. Enzalutamide in men with chemotherapynaive metastatic castrationresistant prostate cancer. If alternative treatments cannot be used, consider a dose reduction of the cyp2d6 substrate drug. Pdf enzalutamide in castrationresistant prostate cancer. Xtandi is an androgen receptor inhibitor indicated for the treatment of patients with. Enzalutamide drug monograph pharmacy benefit management. Department of health and human services, centers for disease control and prevention, national institute for occupa.
Many of these patients had other factors that lowered seizure threshold. The recommended dose of xtandi is 160 mg four 40 mg capsules administered orally once daily. It is able to inhibit binding of androgens to the ar, ar nuclear translocation, and the association of. Do not take more than your prescribed dose in one day. Enzalutamide is also being studied in the treatment of other types of cancer. Dec 16, 2019 following single oral administration of 14 c enzalutamide 160 mg, 85% of the radioactivity is recovered by 77 days post dose. Take enzalutamide at around the same time every day. Special pediatric considerations are noted when applicable, otherwise adult provisions apply. Enzalutamide in men with nonmetastatic, castration. Fda approves supplemental new drug application for xtandi. If the file has been modified from its original state, some details may not fully reflect the modified file.
Enzalutamide for metastatic hormone relapsed prostate. Oct 04, 2018 enzalutamide in castrationresistant prostate cancer article pdf available in new england journal of medicine 37914. Enzalutamide in biochemical relapse of prostate cancer in a trial, the median metastasisfree survival among men with nonmetastatic, castrationresistant prostate cancer and a short psa doubling ti. Keep taking enzalutamide as you have been told by your doctor or other health care provider, even if you feel. Xtandi enzalutamide prior auth criteria proprietary information. Advise patients of the risk of developing a seizure while receiving xtandi. This file contains additional information, probably added from the digital camera or scanner used to create or digitize it. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016.
By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Enzalutamide is the generic name for the trade name drug xtandi. Zytiga is an inhibitor of the hepatic drugmetabolizing enzymes cyp2d6 and cyp2c8. Enzalutamide is medication taken by mouth to slow tumor growth and alleviate symptoms. We are here to answer questions about your insurance coverage or accessing your astellas medication.
For the treatment of patients with metastatic castrationresistant prostate cancer. It has been demonstrated impressive affinity to the ar compared to the firstgeneration ar inhibitors. Xtandi enzalutamide capsules, for oral use initial u. The ingredients of the soft capsule shell are gelatin, sorbitol sorbitan solution see section 2, glycerol, titanium dioxide e171, and purified water. If you miss a daily dose, take xtandi at your regular time the next day. There are no generic xtandi enzalutamide products available at this time. Xtandi is indicated for the treatment of patients with metastatic castration resistant prostate cancer who have previously received docetaxel.
Xtandi 40mg soft capsules patient information leaflet. Enzalutamide in patients progressing post docetaxel affirm affirm is the key trial that supports the use of enzalutamide for the treatment of patients with mcrpc postdocetaxel, the first approved indication for enzalutamide scher et al. If you are allergic to enzalutamide, this may result in a rash or swelling of the face, tongue, lip or throat. Xtandi is indicated for the treatment of patients with metastatic castrationresistant prostate cancer who have previously received docetaxel.
Following single oral administration of 14 cenzalutamide 160 mg, 85% of the radioactivity is recovered by 77 days post dose. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for xtandi enzalutamide skip to. Enzalutamide in men with nonmetastatic, castrationresistant. Xtandi is indicated for men with castrationresistant prostate cancer crpc, prostate cancer that is. Enzalutamide is an androgen receptor inhibitor for the treatment of castrationresistant prostate cancer. It works by blocking the effect of the hormone testosterone on prostate cancer cells.
Xtandi enzalutamide was approved by the food and drug administration fda for the treatment of a type of prostate cancer that. Enzalutamide uses, dmf, dossier, manufacturer, supplier. Xtandi contains sorbitol see dosage forms, composition and packaging. Starting from 4bromo2fluorobenzonic acid, a methyl esterification, ullmann ligation, methyl esterification, ring closing reaction and final methyl amidation provided the target in 35% total yield with 99. Bottles of 120 capsules ndc 0469012599 recommended storage. Most prostate cancers need the hormone testosterone to grow. It is usually taken with or without food once a day. Xtandi support solutions a is designed as a single point of contact to help patients understand their coverage and reimbursement options when they are prescribed xtandi enzalutamide. This emedtv web page discusses when a generic version of this drug might become available. Enzalutamide xtandi is a type of hormone therapy for men with prostate cancer that has spread to other parts of the body advanced prostate cancer and has stopped responding to other types of hormone therapy.
Sep 27, 2017 showall page 1 enzalutamide oral chemotherapy education name of your medication generic name enzalutamide enzuhlootuhmide brand name xtandi ekstandee approved uses enzalutamide is used to treat men with prostate cancer dose and schedule taking enzalutamide as instructed is important to allow your treatment to be as effective as possible so here are some key points to. Xelodawarfarin interaction xeloda warfarin interaction. If patients must be coadministered a strong cyp2c8 inhibitor, the dose of enzalutamide should be reduced to 80 mg. Patients receiving concomitant capecitabine and oral coumarin. It blocks the effect of testosterone which is a male sex hormone. It also explains the difference between a generic name and generic version of a drug. Some side effects of enzalutamide may occur that usually do not need medical. Xtandi capsules are available in the following package sizes. Highlights of prescribing information perforation can occur. Do not change or stop taking your prescribed dose of xtandi without talking with your doctor first. Seizures occurred in 7 of 800 enzalutamide patients. Downloadable patient resources xtandi enzalutamide. Highlights of prescribing information these highlights do not include all the information needed to use xtandi safely and effectively. Enzalutamide in castrationresistant prostate cancer article pdf available in new england journal of medicine 37914.
134 809 632 1395 146 256 806 1442 1198 1392 805 1262 900 117 1320 142 1375 1095 538 301 1045 370 399 254 1114 920 1661 1499 205 1478 960 94 412 1141 527 287 530 1450 8 1492 1268 586 1454 584 1242 990 952