Xofigo is an alpha particleemitting radioactive therapeutic agent indicated for the treatment of patients with castrationresistant prostate cancer, symptomatic. These highlights do not include all the information needed to use halaven safely and effectively. Thirty patients were randomized to receive aredia and 35 to receive etidronate disodium. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body.
Xofigo, inn radium223 dichloride european medicines agency. Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. All care decisions are solely the responsibility of your healthcare provider. The ncpe has issued a recommendation regarding the use of radium223 for this. Currently there is an ongoing phase vii clinical trial investigating the use of radium223 in combination with docetaxel for use in treatment of crpc and bone metasteses. Severe mucocutaneous reactions, some with fatal outcomes 5. Order xofigo for your patients through xofigo access services. Xofigo is a readytouse solution and should not be diluted or mixed with any solutions. Xofigo fda prescribing information, side effects and uses.
Anaphylaxis anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, andor angioedema of the throat or tongue, has been reported to occur after administration of xolair. For more information about xermelo, talk to your doctor or see full prescribing information. Xofigo package insert, bayer healthcare pharmaceuticals website. Since the xofigo treatment now discontinued, he might regain some of his strength back. Xofigo reimbursement informatin and support, xofigo website. Patients with castrationresistant prostate cancer crpc with symptomatic bone metastases prior to first administering xofigo. Concurrent chemotherapy with xofigo is considered experimental, investigational or unproven. The following has been reported to occur with xofigo. Important safety information this product should not be used in premature infants in the neonatal intensive care unit nicu setting.
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. Reimbursement policy xofigo radioactive therapeutic agent. Radium223 is a radioactive drug that behaves in a similar way to calcium. Dailymed xofigo radium ra 223 dichloride injection. The receipt, storage, use, transfer and disposal of xofigo are subject to the regulations andor appropriate licenses of the competent official organization. Xofigo radium ra 223 dichloride injection, for intravenous use initial u. Prescribing xofigo xofigo radium ra 223 dichloride.
Find patient medical information for xofigo intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Cost effectiveness of radium223 xofigo for castration. Highlights of prescribing information these highlights do not include all the information needed to use xtandi safely and effectively. Follow applicable special handling and disposal procedures. Radium ra 223 dichloride, an alpha particleemitting pharmaceutical, is a radiotherapeutic drug. Xofigo radium ra 223 dichloride injection is an alpha particleemitting. 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. Xofigo is an alphaparticle emitting radio isotope radium223 dichloride. Xofigo is indicated for the treatment of patients with castrationresistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
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. Xofigo package insert keyword after analyzing the system lists the list of keywords related and the list of websites with related content, in addition you can see which keywords most interested customers on the this website. Instructions for preparation parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Sections or subsections omitted from the full prescribing information are not listed. Medication errors resulting from confusion between trastuzumab herceptin and adotrastuzumab emtansine kadcyla have been reported. 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. Anaphylaxis has occurred as early as after the first dose of xolair, but. Gray color you mentioned might be significant anemia for which a prbc transfusion or gcsf might be considered prior to hospice transfer. See full prescribing information for complete boxed warning. Dailymed octreoscan indium in 111 pentetreotide kit. Xofigo can harm unborn babies when given to a pregnant woman. Click a box to download the package insert in pdf format. Monitor patients and discontinue rituxan infusion for severe reactions 5. Official site for healthcare professionals nexavar.
Because of the potential for serious adverse reactions in a breastfed child from nexavar, advise lactating women not to breastfeed during treatment with nexavar and for 2 weeks after the last dose. Xofigo is a therapeutic alpha particleemitting pharmaceutical with targeted anti tumour effect on bone metastases. Jevtana is a prescription medicine used with the steroid medicine prednisone to treat men with prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has worsened after treatment with other medicines, including docetaxel. Treatment protocols for prostate cancer are provided below, including general treatment recommendations and those for localized prostate cancer, for recurrent disease, and for advanced or metastatic disease. The mean baselinecorrected serum calcium for the aredia 60mg and etidronate disodium groups were. Concurrent chemotherapy with xofigo is considered experimental, investigational or. Xofigo radium ra 223 dichloride solution for injection. Xofigo package insert keyword found websites listing. Page 2 of 3 this hne clinical criteria is only a screening tool. Radium223 dichloride is an alpha particleemitting radiotherapy drug that mimics.
Bridging the gap from knowledge to practice in castration. Prescribing xofigo xofigo radium ra 223 dichloride for hcps. Access services forms xofigo radium ra 223 dichloride. To register your xofigo patients for support services, download, fill out, and fax the relevant required forms below to 18559634463 or call 18556xofigo 18556963446. 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. Efficacy and safety of radium223 dichloride in patients with castrationresistant prostate cancer and symptomatic bone metastases, with or. Zytiga abiraterone acetate is a prescription medicine that is used along with prednisone. 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. Xofigo prior authorization criteria 2016 health new england, inc. Prescription treatment with zytiga abiraterone acetate. Xofigo an alpha particleemitting pharmaceutical should be received, used and administered only by authorized persons in designated clinical settings.
Highlights of prescribing information these highlights do not include all the information needed to use xofigo safely and effectively. Lutathera lutetium lu 177 dotatate is indicated for the treatment of somatostatin receptorpositive gastroenteropancreatic neuroendocrine tumors gepnets, including foregut, midgut and hindgut neuroendocrine tumors in adults. Cost effectiveness of radium223 xofigo for castrationresistant prostate cancer with symptomatic bone metastases and no known visceral metastases. Xofigo radium ra 223 dichloride injection an alpha particleemitting radioactive therapeutic agent that is administered intravenously at fourweek intervals for six months. Highlights of prescribing information recurrent or. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. For important risk and use information about nexavar, please see the full prescribing information. Medical coverage policy radium223, xofigo for treatment. Xtandi enzalutamide capsules, for oral use initial u. Downloadable resources xofigo radium ra 223 dichloride. Provengesipuleucel t advanced prostate cancer treatment. Diagnosis and staging, a critical images slideshow, to help determine the best diagnostic approach for this potenti. Having the needle inserted feels similar to having blood taken.
Xofigo radium ra 223 dichloride injectable medication. I am very sorry to hear about your husbands advanced pca. There are small percentages of bone marrow failure, but most of those patient already had failing or failed bone marrow prior to the xofigo injection. Xofigo for castrationresistant prostate cancer radium ra.
Xgevadenosumab injection, for subcutaneous use initial usapproval. Radium223 223 ra, ra223 was discovered in 1905 by t. Food and drug administration fda approved radium ra 223 dichloride xofigo injection. Highlights of prescribing information posterior reversible. 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. View the clinical data for xofigo radium ra 223 dichloride injection, including efficacy, safety, and information on support services. Before taking xofigo, tell your healthcare provider if you. Xofigo access services enrollment form for administering providers pdf. Radium ra 223 dichloride xofigo is used in men who have prostate cancer that has spread to their bones. Dec 01, 2019 xofigo may impair fertility and reproductive function in humans based on its mechanism of action. 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 50419020801. Xofigo radium ra 223 dichloride is a therapeutic alpha particleemitting pharmaceutical with targeted antitumour effect on bone metastases. The drug mimics calcium and forms complexes with the bone mineral at sites of bone metastases. Xofigo radium ra 223 dichloride injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone.
Xofigo treatment regimen administered on a patientspecific basis treatment activity is based on patient body weight 1. Patients with castrationresistant prostate cancer crpc with symptomatic bone metastases prior to first administration of xofigo. Xofigo radium ra 223 dichloride injection is an alpha particleemitting radioactive therapeutic agent which mimics calcium and forms complexes with hydroxyapatite at areas of increased bone turnover, such as bone metastases. Some references, information systems, and internet sites omit the ado portion of the generic name, resulting in confusion between the 2 drugs. Zytiga is used to treat men with prostate cancer that has spread to other parts of the body. Xofigo radium ra 223 dichloride injectable medication precertification request aetna precertification notification phone. Xofigo package insert pdf how is xofigo administered. The receipt, storage, use, transfer and disposal of xofigo are subject to the regulations andor appropriate licenses of. This hne clinical criteria is confidential and proprietary. Highlights of prescribing information bayer healthcare. Xofigo page 1 of 29 product monograph xofigo radium ra 223 dichloride solution for injection 1100 kbqml 29.
Pediatrics 65years of age no dosage adjustment is considered necessary in elderly patients. Xofigo radium 223 dichloride chemotherapy drug information. Xofigo is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with ph between 6 and 8. Xofigo is not to be used in women who are, or may be, breastfeeding. It is apparent that there is some mylosuppression associated with this radiotracer. It then emits alpha particles, causing the destruction of dna in nearby cells, resulting in cancer cell death in the bone. Dec 10, 2019 xofigo an alpha particleemitting pharmaceutical should be received, used and administered only by authorized persons in designated clinical settings. Guideline members are eligible for coverage of xofigo when the following criteria are met. Radium ra 223 dichloride xofigo is a drug used to kill cancer cells in bone through emitting radioactive particles that alter the cells dna.
In addition, the kit also contains the following items. Quadramet radiopharmaceutical for bone pain lantheus. Xofigo radium ra 223 dichloride injection, for intravenous use. Before getting provenge, tell your doctor about all your medical problems, including problems with your heart or lungs, or if you have had a stroke. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Xofigo is radium ra 223 dichloride, an alpha particleemitting radioactive therapeutic agent.
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