Xofigo is indicated for the treatment of patients with castrationresistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. This xofigo price guide is based on using the discount card which is accepted at most u. To register your xofigo patients for support services, download, fill out, and fax the relevant required forms below to 18559634463 or call 18556xofigo 18556963446. Xgevadenosumab injection, for subcutaneous use initial usapproval. Xofigo radium 223 dichloride is a member of the therapeutic radiopharmaceuticals drug class and is commonly used for prostate cancer. Xofigo is indicated for the treatment of patients with castrationresistant prostate cancer. The fda approved for the treatment of patients with castrationresistant prostate cancer, symptomatic bone metastases and no known or. After some good success with enzalutamide, my psa started to. Reimbursement policy xofigo radioactive therapeutic agent. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis see adverse reactions 6. I was on zytiga and xofigo from may 9th through end of october this year. Until such data are available, hydroxyzine is contraindicated in early pregnancy.
Highlights of prescribing information these highlights do not. Xofigo reimbursement informatin and support, xofigo website. Xofigo is an alpha particleemitting radioactive therapeutic agent indicated for the treatment of patients with castrationresistant prostate cancer, symptomatic. Bridion sugammadex injection is a sterile, clear, colorless to slightly yellowbrown, nonpyrogenic aqueous solution intended for intravenous infusion. Cms has assigned a productspecific hcpcs code for xofigo, a9606.
Find patient medical information for xofigo intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Xofigo radium ra 223 dichloride injection is an alpha particle emitting radioactive therapeutic agent indicated for the treatment of patients with castration resistant prostate cancer crpc, symptomatic bone. In this section, youll find information about the clinical data and safety profile for xofigo. Why is dailymed no longer displaying pill images on the search results and drug info pages. The healthcare professional will flush the intravenous access line or cannula before and after injection with a saline solut ion. Xofigo is radium ra 223 dichloride, an alpha particleemitting radioactive therapeutic agent. Xofigo radium ra 223 dichloride injection is supplied in singleuse vials containing 6 ml of solution at a concentration of 1,100 kbqml 30 microcurieml with a total radioactivity of 6,600 kbqvial 178 microcurievial at the reference date ndc 5041920801. For 7 of patients treated with xofigo bone marrow failure was ongoing at the time of death. In late sep, psa started rising again, so stopped both zytiga and xofigo due to apparent ineffectiveness in my case. Follow applicable special handling and disposal procedures. Xofigo radium ra 223 dichloride injectable medication. Dec 14, 2009 why is dailymed no longer displaying pill images on the search results and drug info pages. All care decisions are solely the responsibility of your healthcare provider.
Whats killing patients in bayers xofigo combo study. A spanish version of the guide to help you with xofigo. Highlights of prescribing information marked bradycardia. In some cases, health care professionals may use the trade name xofigo when referring to the generic drug name radium 223 dichloride.
In ama style, the elements of a citation for a package insert are as follows note that you may wish to include a trademark symbol if appropriate for the drug name. Xofigo dosage and administration recommended dosage. Dosing information xofigo radium ra 223 dichloride for hcps. The receipt, storage, use, transfer and disposal of xofigo are subject to the regulations andor appropriate licenses of the competent official organization. The administration of xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Xofigo can cause fetal harm when administered to a pregnant female. Highlights of prescribing information these highlights do not include all the information needed to use xulane safely and effectively. Xifaxan is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in xifaxan. At the primary analysis of the phase 3 era223 study that evaluated concurrent initiation of xofigo in combination with abiraterone acetate plus prednisoneprednisolone in 806 asymptomatic or mildly symptomatic mcrpc patients, an increased incidence of fractures 28. Before taking xofigo, tell your healthcare provider if you. Important safety information this product should not be used in premature infants in the neonatal intensive care unit nicu setting. Find information about a drug food and drug administration.
If you need help accessing information in different file formats. Celebrex doses of 100 mg twice daily and 200 mg twice daily were similar in effectiveness and both were comparable to. Drugs benefits go beyond pain palliation in prostate cancer despite the fact that it has been three years since the drug was approved by the fda, many oncologists still need to be educated regarding xofigo s benefits beyond pain palliation. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body. Radium 223 dichloride xofigo radiopharmaceutical agent. Dec 01, 2017 back in the spring of 2016, researchers reported that a combination of bayers xofigo radium223 with zytiga abiraterone came through with evidence of significantly reduced bone pain for men. Xofigo prior authorization criteria 2016 health new england, inc. Xofigo treatment regimen administered on a patientspecific basis treatment activity is based on patient body weight 1. Xofigo an alpha particleemitting pharmaceutical should be received, used and administered only by authorized persons in designated clinical settings. Xofigo prices, coupons and patient assistance programs.
Xofigo radium ra223 dichloride package leaflet v10xx03. View a number of resources with dosing information and administration instructions for xofigo radium ra 223 dichloride. Radium223 was approved by the fda based on the results of a single, phase 3 clinical trialthe. To be clear, the year of publication refers to the latest available revision of the drug package insert, which can be found on the fda website. Xofigo is a therapeutic alpha particleemitting pharmaceutical with targeted anti tumour effect on bone metastases. Information on drug trial snapshots, medication guides, drug. Diminished effectiveness in poor metabolizers see full prescribing information for complete boxed warning. Prescribing xofigo xofigo radium ra 223 dichloride.
Celebrex was shown to be superior to placebo in these studies, using the acr20 responder index, a composite of clinical, laboratory, and functional measures in ra. Read more how to identify appropriate patients, and available support services, including an administering site locator. Dec 01, 2019 xofigo may impair fertility and reproductive function in humans based on its mechanism of action. Every effort is made to ensure that these are regularly updated. Prescribe xofigo xofigo radium ra 223 dichloride for hcps. The safety and efficacy of xofigo have not been established in females. Xofigo fda prescribing information, side effects and uses. Highlights of prescribing information these highlights do not include all the information needed to use xifaxan safely and effectively. Xofigo page 4 of 29 geriatrics 65years of age no dosage adjustment is considered necessary in elderly patients. If she does not get her period within a week after taking the last active pill or removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant. Food and drug administration fda approved radium ra 223 dichloride xofigo injection. Xofigo radium 223 dichloride chemotherapy drug information.
Radium223 223 ra, ra223 was discovered in 1905 by t. Prescribing xofigo xofigo radium ra 223 dichloride for hcps. Xofigo radium ra 223 dichloride injectable medication precertification request aetna precertification notification phone. Xofigo, inn radium223 dichloride european medicines agency. Celebrex doses of 100 mg twice daily and 200 mg twice daily were similar in effectiveness and both were comparable to naproxen 500 mg twice daily. Xofigo is an alpha particleemitting radioactive therapeutic agent. Radium ra223 dichloride xofigo xofigo is a novel radiopharmaceutical, radium 223 dichloride. So this seems to be a good time to provide an informal update of our experience with xofigo to the present time. The efficacy and safety of xofigo were evaluated in a doubleblind, randomized, placebocontrolled phase 3 clinical trial of patients with castrationresistant prostate cancer with symptomatic bone metastases. Radium223 dichloride is an alpha particleemitting radiotherapy drug that mimics. Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. Back in the spring of 2016, researchers reported that a combination of bayers xofigo radium223 with zytiga abiraterone came through with evidence of. The alpha radiation provides the therapeutic effects with its high linear energy transfer.
Xofigo can harm unborn babies when given to a pregnant woman. Xofigo radium 223 dichloride is the generic name for the trade name drug xofigo. For specific pages follow the instructions as also given in the template dialog box of the pdfpages template in the file tab of the lyx. Qtern dapagliflozin and saxagliptin is indicated as an adjunct to diet and exercise to. Xofigo radium ra 223 dichloride injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. Duration of the procedure xofigo is given once every 4 weeks for a total of 6 injections.
Bone marrow might regenerate and gi symptoms might resolve. Duration of the procedurexofigo is given once every 4 weeks for a total of 6 injections. Package insert reference guide for pharmacy students. Inserting a multipaged pdf document in a lyx document. Xofigo radium223 injection is used for the treatment of. Xofigo will be injected slowly via a needle into one of your veins intravenously. Xofigo is indicated for the treatment of patients with castrationresistant.
Safety and efficacy with the combination of xofigo and agents other than gonadotropinreleasing hormone analogues have not been established. The following package inserts, as listed above, are approved by the relevant health authorities. Xofigo package insert, bayer healthcare pharmaceuticals website. Due to inconsistencies between the drug labels on dailymed and the pill images provided by rximage, we no longer display the rximage pill images associated with drug labels we anticipate reposting the images once we are able identify and filter out images that do not match the information. Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. No dosage adjustment is necessary in elderly patients. The clinical trial that led to xofigos approval by the fda was a prospective, placebocontrolled study demonstrating improved survival in xofigotreated men compared to men treated with placebo alone.
Xofigo radium ra 223 dichloride injection, for intravenous use initial u. So after xofigo is injected into the patient, it travels through the blood stream and concentrates in the irritated areas of the bone and emits radiation where the cancer is. After it is injected into the blood stream it concentrates near the cancer and delivers a potent dose of radiation. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. Dailymed xofigo radium ra 223 dichloride injection. Please see the full prescribing information for xofigo assay the dose immediately before treatment, and set up the infusion environment by placing absorbent materials in the area where the injection will take place. Click a box to download the package insert in pdf format. Men should use condoms and make sure female partners who may become pregnant use birth control contraception during treatment and for 6 months after completing treatment with xofigo. In the phase 3 alsympca trial, 2% of patients in the xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. Dec 10, 2019 xofigo an alpha particleemitting pharmaceutical should be received, used and administered only by authorized persons in designated clinical settings. I received 3 xofigo infusions over that time, never had any reaction or side affects at all.
Downloadable resources xofigo radium ra 223 dichloride. I have stage iv prostate cancer it has metastasized into my whole skeleton. Xofigo is made out of radium, a radioactive element. The active moiety of xofigo is the isotope ra223 as ra223 dichloride, which mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. Xulane norelgestromin and ethinyl estradiol transdermal system initial u. Purdue university is an equal accessequal opportunity university. Effectiveness of plavix depends on activation to an active metabolite by the cytochrome p450 cyp system, principally cyp2c19. Due to inconsistencies between the drug labels on dailymed and the pill images provided by rximage, we no longer display the rximage pill images associated with drug labels.
Please see the full prescribing information for xofigo. Highlights of prescribing information these highlights do not include all the information needed to use xofigo safely and effectively. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. After some good success with enzalutamide, my psa started to rise sharply so xofigo was recommended. Since the xofigo treatment now discontinued, he might regain some of his strength back. Fda provides consumers and industry stakeholders links to web sites that provide info on drug approval and safe use. Patients with castrationresistant prostate cancer crpc with symptomatic bone metastases prior to first administration of xofigo.
Xofigo lookup table for prescribed ra 223 activity pdf. Xofigo radium ra 223 dichloride injection prescribing information. Access services forms xofigo radium ra 223 dichloride. I am very sorry to hear about your husbands advanced pca. This hne clinical criteria is confidential and proprietary. Clinical data in human beings are inadequate to establish safety in early pregnancy. Of the 600 patients treated with xofigo in the randomized phase iii study, 75% were 65 years of age and over 25% were. Gray color you mentioned might be significant anemia for which a prbc transfusion or gcsf might be considered prior to hospice transfer. May 30, 2014 i am very sorry to hear about your husbands advanced pca.
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