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. Dear healthcare professional letter for xofigo radium ra 223. Dec 01, 2019 why is dailymed no longer displaying pill images on the search results and drug info pages. 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. 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. Highlights of prescribing information for intravenous. 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. 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.
Scanner is hp photosmart c4580 have tried to insert but cannot find anything under the insert tab related to a. Pediatrics xofigo in pediatric patients have not been studied. Medical coverage policy radium223, xofigo for treatment. Radium223 dichloride in combination with vascular endothelial. Scanner is hp photosmart c4580 have tried to insert but cannot find anything under the insert tab related to a document. Access services forms xofigo radium ra 223 dichloride. Aug 25, 2014 i have had no nausea related to xofigo. Highlights of prescribing information bayer healthcare. Highlights of prescribing information these highlights do not include all the information needed to use xofigo safely and effectively. Geriatrics 65years of age no dosage adjustment is considered necessary in elderly patients. Xofigo access services forms to register your xofigo patients for support services, download, fill out, and fax the relevant required forms below to 18559634463 or call 18556xofigo 18556963446.
Please see the full prescribing information for xofigo. Radium ra 223 dichloride xofigo is a drug used to kill cancer cells in bone through emitting radioactive particles that alter the cells dna. With word 2007 in the xp operating system it was easy, i just clicked and draged pdf the document into the word document. Highlights of prescribing information these highlights do not. Describe xofigo and its physical, chemical, and biological properties as well its mode of decay. Only four studies included the word cost, three economics and none budget in heading or abstract. It is a hospitalonly product licensed as a course of six intravenous injections given at fourweek intervals. 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. No druglimiting toxicity was identified during the safety runin and the. Prescribing xofigo xofigo radium ra 223 dichloride. Celebrex doses of 100 mg twice daily and 200 mg twice daily were similar in effectiveness and both were comparable to. Xofigo package insert keyword found websites listing.
After some good success with enzalutamide, my psa started to rise sharply so xofigo was recommended. Xofigo fda prescribing information, side effects and uses. View the clinical data for xofigo radium ra 223 dichloride injection, including efficacy, safety, and information on support services. 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. In this section, youll find information about the clinical data and safety profile for xofigo.
Xofigo package insert pdf how is xofigo administered. Prescribing xofigo ensures the appropriate patients get the treatment they need. Ra223 treatment for bone metastases in castrateresistant. Radium ra 223 dichloride, an alpha particleemitting pharmaceutical, is a radiotherapeutic drug xofigo is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with ph between 6 and 8. Department of health and human services food and drug administration silver spring md 20993 nda 203971s007 supplement approval bayer healthcare pharmaceuticals inc. Health economics and radium223 xofigo in the treatment of. Xofigo radium ra 223 dichloride injection, for intravenous usedescription. In late sep, psa started rising again, so stopped both zytiga and xofigo due to apparent ineffectiveness in my case.
The receipt, storage, use, transfer and disposal of xofigo are subject to the regulations andor appropriate licenses of the competent official organization. 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. Xofigo is an alphaparticle emitting radio isotope radium223 dichloride. Whats killing patients in bayers xofigo combo study. Dailymed xofigo radium ra 223 dichloride injection. Inappropriate dosage instructions in package inserts.
Of these, only radium223 ra223 specifically targets bone metastases. Integration of radium223 dichloride xofigo into clinical practice for. Xofigo radium ra 223 dichloride injection is supplied in singleuse vials containing 6 ml of solution at a concentration of 1,000 kbqml 27 microcurieml with a total radioactivity of 6,000 kbqvial 162 microcurievial at the reference date ndc 5041920801. Find patient medical information for xofigo intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Xofigo is not to be used in women who are, or may be, breastfeeding. Highlights of prescribing information these highlights do not include all the information needed to use xulane safely and effectively. How do i insert a scan from my scanner into a word 2010.
I have been recieving treatments in tampa and in ky. Xofigo can cause fetal harm when administered to a pregnant woman. The safety and efficacy of xofigo have not been established in females. Follow applicable special handling and disposal procedures. If your patient needs assistance with outofpocket costs associated with xofigo, the access counselor will send the xofigo application for patient assistancecommercial copay assistance.
Back in the spring of 2016, researchers reported that a combination of bayers xofigo radium223 with zytiga abiraterone came through with evidence of. Click a box to download the package insert in pdf format. Xofigo treatment regimen administered on a patientspecific basis treatment activity is based on patient body weight 1. After some good success with enzalutamide, my psa started to. Read more how to identify appropriate patients, and available support services, including an administering site locator.
Prostate cancer is the second leading cause of cancerrelated death in the united states among men and the most frequently diagnosed cancer in. Xofigo is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with ph between 6 and 8. Health economics and radium223 xofigo value in health. Patients with castrationresistant prostate cancer crpc with symptomatic bone metastases prior to first administration of xofigo. Xofigo, inn radium223 dichloride european medicines agency. How do i insert a scan from my scanner into a word 2010 document please. Xulane norelgestromin and ethinyl estradiol transdermal system initial u.
Cost effectiveness of radium223 xofigo for castration. Important safety information this product should not be used in premature infants in the neonatal intensive care unit nicu setting. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body. 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 is indicated for the treatment of patients with castrationresistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. These highlights do not include all the information needed to use. Xofigo an alpha particleemitting pharmaceutical should be received, used and administered only by authorized persons in designated clinical settings. This medicinal product is subject to additional monitoring. Among patients who received xofigo, the laboratory abnormality grade 34 thrombocytopenia occurred in 1% of docetaxel naive patients and in 4% of patients who had received prior docetaxel.
Radium223 in renal cell carcinoma with bone metastases 5560 characters with spaces. Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. Just super tired after the 4th one and 5th one last one is in sept. Xgevadenosumab injection, for subcutaneous use initial usapproval. Downloadable resources xofigo radium ra 223 dichloride. Xofigo package insert, bayer healthcare pharmaceuticals website. 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 xofigos benefits beyond pain palliation. 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. Two trials examine adding ra223 to abiraterone or enzalutamide early in the. Bone metastases castrationresistant prostate cancer overall survival radium223. As an adverse reaction, grade 34 thrombocytopenia was reported in 6% of patients on xofigo and in 2% of patients on placebo. Xofigo radium ra 223 dichloride is a therapeutic alpha particleemitting. Radium223 dichloride xofigo is an fdaapproved radionuclide used to treat symptomatic bone metastases in patients with.
Xofigo radium ra 223 dichloride injection, for intravenous use. Pdf inappropriate dosage instructions in package inserts. Study protocol and statistical analysis plan pdf january 9, 2017. The authorized user au of xofigo is a physician who is approved and listed on the ram license for therapeutic use of radium ra 223 dichloride. None of the publications were thorough of cost analysis. Medical coverage policy radium223, xofigo for treatment of. The spl will be accessible from publicly available labeling repositories. Prescribing xofigo xofigo radium ra 223 dichloride for hcps. Dec 01, 2019 xofigo may impair fertility and reproductive function in humans based on its mechanism of action.
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. Xofigo radium ra 223 dichloride injectable medication. Department of health and human services food and drug administration silver spring md 20993 nda 203971s007. Xofigo radium ra 223 dichloride injection, for intravenous use initial u. The drug mimics calcium and forms complexes with the bone mineral at sites of bone metastases. I have stage iv prostate cancer it has metastasized into my whole skeleton. Xofigo dosage and administration recommended dosage. Counselor, or you can fax a completed xofigo order form to 18559634463 to start the process of treating a patient and an access counselor will contact you. For outlook, click inside of the body of an item, such as an email message or calendar event. It then emits alpha particles, causing the destruction of dna in nearby cells, resulting in cancer cell death in the bone. Dear healthcare professional letter for xofigo radium ra. I received 3 xofigo infusions over that time, never had any reaction or side affects at all. Radium ra 223 dichloride xofigo is used in men who have prostate cancer that has spread to their bones.
Xofigo radium ra 223 dichloride injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. 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. Xofigo lookup table for prescribed ra 223 activity pdf. Prescribe xofigo xofigo radium ra 223 dichloride for hcps. Xofigo radium ra 223 dichloride is a radiotherapeutic drug used to treat patients with castrationresistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo radium 223 dichloride chemotherapy drug information. Safety and efficacy with the combination of xofigo and agents other than gonadotropinreleasing hormone analogues have not been established. Dec 10, 2019 xofigo an alpha particleemitting pharmaceutical should be received, used and administered only by authorized persons in designated clinical settings. The receipt, storage, use, transfer and disposal of xofigo are subject to the regulations andor appropriate licenses of. The first alpha particleemitting radioactive agent for the treatment of castrationresistant prostate cancer with symptomatic bone metastases.
Dosing information xofigo radium ra 223 dichloride for hcps. This tutorial gives an overview of palliation of pain using ra223 chloride xofigo. Xofigo therapy involves a slow intravenous injection over 1 minute. Why is dailymed no longer displaying pill images on the search results and drug info pages.
Department of health and human services silver spring md 20993. Several people on this board report success with xofigo and pain relief. Qtern dapagliflozin and saxagliptin is indicated as an adjunct to diet and exercise to. Clinical efficacy data xofigo radium ra 223 dichloride. Reimbursement policy xofigo radioactive therapeutic agent. Use of xofigo should be discontinued if hematologic values do not recover within six to eight weeks after the last administration of xofigo.
1564 812 1162 1157 46 416 643 1164 648 1479 1466 1010 200 361 604 848 218 1222 239 585 1549 1585 980 719 272 1077 1267 519 1212 92 1564 991 660 80 809 722 1248 307 1243 256 545 232