{"id":32931,"date":"2022-11-15T09:21:13","date_gmt":"2022-11-15T09:21:13","guid":{"rendered":"https:\/\/zeepedia.com\/?p=32931"},"modified":"2022-11-16T10:36:35","modified_gmt":"2022-11-16T10:36:35","slug":"xofigo","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/xofigo\/","title":{"rendered":"Xofigo &#8211; Radium Ra\u2011223\u2011dichloride uses, dose and side effects"},"content":{"rendered":"\n<p>radium Ra\u2011223\u2011dichloride<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Xofigo is and what it is used for<\/h2>\n\n\n\n<p>This medicine contains the active substance radium Ra-223-dichloride (radium-223-dichloride).<\/p>\n\n\n\n<p>Xofigo is used to treat adults with advanced, castration-resistant prostate cancer\u00a0developing after at least two other cancer treatments except treatment to maintain reduced levels of male sex hormone (hormone therapy), or when another cancer treatment is not possible.\u00a0Castration-resistant prostate cancer is cancer that does not respond to treatment that reduces male sex hormones.\u00a0Xofigo is only used when the disease has spread to the bones and is causing symptoms (eg pain), but without known spread to other internal organs.<\/p>\n\n\n\n<p>Xofigo contains the radioactive substance radium-223, which is similar to\u00a0calcium\u00a0found in the skeleton.\u00a0When injected into the patient, radium-223 reaches the bone where cancer has spread and sends out short-range radiation (alpha radiation) that kills the surrounding tumor cells.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Xofigo<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Xofigo must not be given<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>in combination with abiraterone acetate and prednisone\/prednisolone (used together to treat prostate cancer).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor before you are given Xofigo<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Xofigo should not be given in combination with abiraterone acetate and prednisone\/prednisolone due to a possible increased risk of bone fractures and death.\u00a0In addition, there is uncertainty about the effects of Xofigo in combination with other drugs used to treat prostate cancer.\u00a0Tell your doctor if you are already taking any of these medicines.<\/li><li>If you plan to take Xofigo after treatment with abiraterone and prednisone\/prednisolone, you must wait 5 days before starting treatment with Xofigo.<\/li><li>If you plan to take other cancer medicines after treatment with Xofigo, you must wait at least 30 days before starting treatment.<\/li><li>Xofigo is not recommended if the bone cancer does not cause any symptoms, e.g.\u00a0pain.<\/li><li>Xofigo can reduce the number of\u00a0blood cells\u00a0and\u00a0platelets.\u00a0Before starting treatment and before each subsequent\u00a0dose, the doctor will take blood samples.\u00a0Depending on the results of these tests, the doctor will decide whether the treatment can be started, or continued, or whether it needs to be postponed or stopped.<\/li><li>If you have\u00a0reduced production of\u00a0blood cells\u00a0in the\u00a0bone marrow,\u00a0e.g.\u00a0due to previous\u00a0chemotherapy\u00a0(other medicines used to kill cancer cells) and\/or radiotherapy, you may be at greater risk and your doctor will give you Xofigo with caution.<\/li><li>If your\u00a0tumor\u00a0has spread to a large part of the bone, you may also be at higher risk of having a drop in your\u00a0blood cell\u00a0and\u00a0platelet count\u00a0, so your doctor will give you Xofigo with caution.<\/li><li>The limited amount of data available does not suggest any major differences in blood cell production in patients who received chemotherapy after treatment with Xofigo compared to those who did not receive Xofigo.<\/li><li>There are no data on the use of Xofigo in patients with\u00a0Crohn&#8217;s disease\u00a0(a long-term\u00a0inflammatory\u00a0disease of the intestine) or with\u00a0ulcerative colitis\u00a0(a long-term\u00a0inflammation\u00a0of the large intestine).\u00a0As Xofigo is excreted in the feces, acute\u00a0inflammation\u00a0of the intestine may worsen.\u00a0The doctor will therefore carefully consider whether you can be treated with Xofigo if you suffer from any of these conditions.<\/li><li>If you have untreated\u00a0spinal cord compression\u00a0or are likely to develop spinal cord compression (pressure on the spinal cord which may be due to a\u00a0tumor\u00a0or other injury), your doctor will first treat this condition with standard treatment before starting or continuing treatment with Xofigo.<\/li><li>Tell the doctor if you have\u00a0osteoporosis\u00a0or a known increased risk of\u00a0fracture\u00a0(eg, a\u00a0recent bone fracture, or fragility\u00a0) or are taking or have taken\u00a0steroids\u00a0(eg,\u00a0prednisone\/prednisolone).\u00a0You may have a higher risk of bone fractures.\u00a0The doctor may\u00a0prescribe\u00a0a medicine that prevents bone fractures before starting or resuming treatment with Xofigo.<\/li><li>Talk to your doctor if you experience\u00a0new or unusual pain\u00a0or\u00a0swelling in the bone area\u00a0before, during, or after treatment with Xofigo.<\/li><li>If you have a\u00a0bone fracture, your doctor will first stabilize the\u00a0fracture\u00a0before starting or continuing treatment with Xofigo.<\/li><li>Tell the doctor if you are taking or have taken bisphosphonates or have received\u00a0chemotherapy\u00a0before treatment with Xofigo.\u00a0The risk of\u00a0<em>osteonecrosis\u00a0of the jaw<\/em>\u00a0(dead\u00a0tissue\u00a0in the jawbone mainly seen in patients treated with bisphosphonates) cannot be excluded (see section 4).<\/li><li>Xofigo adds to your overall long-term cumulative exposure to radiation.\u00a0Long-term cumulative exposure to radiation can increase the risk of developing cancer (especially bone cancer and\u00a0leukemia\u00a0) and hereditary abnormalities.\u00a0No case of cancer caused by Xofigo has been reported in\u00a0clinical studies\u00a0with a follow-up period of up to three years.<\/li><\/ul>\n\n\n\n<p>The doctor will examine your bone health before deciding whether you can take Xofigo.\u00a0During treatment and for 2 years after starting treatment with Xofigo, the doctor will continuously monitor your bone health.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>This medicine is not intended for children and adolescents.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Xofigo<\/h2>\n\n\n\n<p>No interaction studies with other drugs have been performed.<\/p>\n\n\n\n<p>Xofigo should not be given in combination with abiraterone acetate and prednisone\/prednisolone due to a possible increased risk of bone fractures and death.&nbsp;In addition, there is uncertainty about the effects of Xofigo in combination with other systemic drugs used to treat metastatic prostate cancer.&nbsp;Tell your doctor if you are already taking any of these medicines.<\/p>\n\n\n\n<p>Talk to your doctor before treatment with Xofigo if you are taking or have taken bisphosphonates or other medicines to protect bone health or if you are taking or have taken&nbsp;steroids&nbsp;(eg prednisone\/prednisolone).&nbsp;You may have a higher risk of bone fractures.<\/p>\n\n\n\n<p>If you take\u00a0calcium,\u00a0phosphate,\u00a0and\/or\u00a0vitamin D, your doctor will carefully assess whether you should temporarily stop taking these substances before you can start treatment with Xofigo.<\/p>\n\n\n\n<p>There are no data on the&nbsp;<strong>use of Xofigo at the same time as&nbsp;chemotherapy<\/strong>&nbsp;(other medicines used to kill cancer cells).<\/p>\n\n\n\n<p>If Xofigo and&nbsp;chemotherapy&nbsp;are used together, the decrease in the number of&nbsp;blood cells&nbsp;and&nbsp;platelets&nbsp;may be increased.<\/p>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Xofigo is not intended for women and must not be given to women who are or may be pregnant or who are breastfeeding.<\/p>\n\n\n\n<p><strong>Contraception&nbsp;in men and women<\/strong><\/p>\n\n\n\n<p>If you have sex with a woman who could become pregnant, you should use an effective method of contraception during and up to 6 months after treatment with Xofigo.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>There is a potential risk that radiation from Xofigo can affect your\u00a0fertility.\u00a0Ask your doctor how this may affect you, especially if you plan to have children in the future.\u00a0You may wish to seek advice on sperm preservation before treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Xofigo is unlikely to affect your ability to drive or use machines.<\/p>\n\n\n\n<p><strong>Xofigo contains&nbsp;sodium<\/strong><\/p>\n\n\n\n<p>Depending on the volume administered, this medicine may contain up to 54 mg of\u00a0sodium\u00a0(the main ingredient in common\/table salt) per\u00a0dose.\u00a0This corresponds to 2.7% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How Xofigo is used<\/h2>\n\n\n\n<p>There are strict laws regarding the use, handling, and destruction of medicines such as Xofigo.\u00a0It will only be used within specially controlled areas.\u00a0This medicine will only be handled and given to you by staff trained and qualified to use it safely.\u00a0The staff will take special care to ensure that the medicine is used safely and will keep you informed of what they are doing.<\/p>\n\n\n\n<p>The&nbsp;dose&nbsp;you receive depends on your body weight.&nbsp;The doctor responsible for the treatment will calculate how much Xofigo should be used for you.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Xofigo is 55 kBq (becquerel, the unit used to express radioactivity) per kilogram of your body weight.<\/p>\n\n\n\n<p>Does\u00a0one not need to be adjusted if you are 65 years of age or older or if you have reduced kidney or liver function?<\/p>\n\n\n\n<p><strong>Administration&nbsp;of Xofigo and how the procedure is performed<\/strong><\/p>\n\n\n\n<p>Xofigo will be injected slowly with a needle into one of your veins (\u00a0intravenously\u00a0).\u00a0The healthcare professional will flush the intravenous catheter or needle with saline before and after the\u00a0injection.<\/p>\n\n\n\n<p><strong>Duration of treatment<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Xofigo is given once every 4 weeks until you have received a total of 6\u00a0injections.<\/li><li>There are no safety and efficacy data available for treatment with more than 6 Xofigo\u00a0injections.<\/li><\/ul>\n\n\n\n<p><strong>After&nbsp;administration&nbsp;with Xofigo<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Care should be taken when handling materials, such as\u00a0bedding, which comes into contact with body fluids (such as spillage of urine, feces, vomit, etc.).\u00a0Xofigo is mainly excreted in feces.\u00a0The doctor will tell you if you need to take any special precautions after receiving this medicine.\u00a0Contact the doctor if you have any questions.<\/li><\/ul>\n\n\n\n<p><strong>If you have been given too much Xofigo<\/strong><\/p>\n\n\n\n<p>An overdose is unlikely.<\/p>\n\n\n\n<p>If an accidental overdose occurs, the doctor will institute appropriate supportive treatment and monitor you for changes in\u00a0blood cell counts\u00a0and gastrointestinal symptoms (eg diarrhea, nausea, vomiting).<\/p>\n\n\n\n<p>If you have further questions about the use of Xofigo, contact the doctor responsible for the treatment.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p><strong>The most serious&nbsp;side effects<\/strong>&nbsp;in patients receiving Xofigo are&nbsp;<strong>:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>decreased number of&nbsp;blood platelets&nbsp;<\/strong>(&nbsp;thrombocytopenia&nbsp;)<\/li><li><strong>reduced number of&nbsp;neutrophils&nbsp;, a type of&nbsp;white blood cell&nbsp;<\/strong>(&nbsp;neutropenia&nbsp;, which can lead to an increased risk of infection).<\/li><\/ul>\n\n\n\n<p><strong>Contact your doctor immediately if you notice the<\/strong>&nbsp;following symptoms as they may be signs of&nbsp;thrombocytopenia&nbsp;or&nbsp;neutropenia&nbsp;(see above):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>abnormal bruising<\/strong><\/li><li>more&nbsp;<strong>bleeding<\/strong>&nbsp;than normal after an injury<\/li><li><strong>fever<\/strong><\/li><li><strong>or if you<\/strong>&nbsp;seem to get many&nbsp;<strong>infections<\/strong>&nbsp;.<\/li><\/ul>\n\n\n\n<p>The doctor will take blood samples before starting treatment and before each&nbsp;injection&nbsp;to check the number of&nbsp;blood cells&nbsp;and&nbsp;platelets&nbsp;(see also section 2).<\/p>\n\n\n\n<p><strong>The most common&nbsp;side effects<\/strong>&nbsp;in patients receiving Xofigo (very common [may affect more than 1 in 10 people]) are&nbsp;<strong>:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>diarrhea<\/strong>, nausea, vomiting,<strong> thrombocytopenia\u00a0(reduced number of\u00a0blood platelets\u00a0), bone fracture.<\/strong><\/li><\/ul>\n\n\n\n<p>Risk of dehydration: tell the doctor if you have any of the following symptoms: dizziness, increased thirst, decreased urine production, or dry skin as these may be symptoms of dehydration.\u00a0It is important to avoid dehydration by drinking plenty of water.<\/p>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;are listed below according to how common they are:<\/strong><\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>decreased number of&nbsp;white blood cells&nbsp;(&nbsp;leukopenia&nbsp;)<\/li><li>reduced number of&nbsp;neutrophils&nbsp;, a type of&nbsp;white blood cell&nbsp;(&nbsp;neutropenia&nbsp;, which can lead to an increased risk of infection)<\/li><li>reduced number of red and&nbsp;white blood cells&nbsp;and&nbsp;platelets&nbsp;(pancytopenia)<\/li><li>injection site reactions (eg skin redness (&nbsp;erythema&nbsp;), pain and swelling)<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect up to 1 in 100 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>decreased number of&nbsp;lymphocytes&nbsp;, a type of&nbsp;white blood cell&nbsp;(lymphopenia)<\/li><li>osteoporosis&nbsp;_&nbsp;_<\/li><\/ul>\n\n\n\n<p>Xofigo adds to your overall long-term cumulative exposure to radiation.&nbsp;Long-term cumulative exposure to radiation can increase the risk of developing cancer (especially bone cancer and&nbsp;leukemia&nbsp;) and hereditary abnormalities.&nbsp;No case of cancer caused by Xofigo has been reported in&nbsp;clinical studies&nbsp;with a follow-up period of up to three years.<\/p>\n\n\n\n<p>Contact a doctor if you experience symptoms such as pain, swelling, or numbness in the jaw, &#8220;a heavy feeling in the jaw&#8221; or\u00a0tooth loss.\u00a0Cases of\u00a0<em>osteonecrosis\u00a0of the jaw<\/em>\u00a0(dead\u00a0tissue\u00a0in the jaw bone mainly seen in patients treated with bisphosphonates) have occurred in patients treated with Xofigo.\u00a0All cases have only occurred in patients who received bisphosphonates before or at the same time as Xofigo treatment and\u00a0chemotherapy\u00a0before treatment with Xofigo.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Xofigo<\/h2>\n\n\n\n<p>You do not need to store this medicine.\u00a0The specialist is responsible for this medicine being stored in suitable premises.\u00a0Storage of radioactive medicines will take place by national regulations for radioactive material.<\/p>\n\n\n\n<p>The following information is intended for the specialist only:<\/p>\n\n\n\n<p>Xofigo must not be used after the expiry date stated on the vial and lead container.<\/p>\n\n\n\n<p>No special temperature instructions.<\/p>\n\n\n\n<p>Xofigo must not be used if it is discolored, contains particles, or if the container is damaged.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Contents declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The\u00a0<strong>active substance<\/strong>\u00a0is: radium Ra-223 dichloride (radium-223\u2011dichloride).<br>One ml of solution contains 1100 kBq radium-223 dichloride, corresponding to 0.58 ng radium-223 at the reference date.<br>One\u00a0vial\u00a0contains 6 ml of solution (6600 kBq of radium-223 dichloride at the reference date).<\/li><li><strong>The other ingredients<\/strong>\u00a0are water for injections, sodium citrate, sodium chloride, and\u00a0hydrochloric acid\u00a0(see the end of section 2 for more information about\u00a0sodium\u00a0).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Xofigo is a clear and colorless&nbsp;solution for injection&nbsp;.&nbsp;It is supplied in a clear glass&nbsp;vial&nbsp;closed with a gray rubber stopper and aluminum seal.&nbsp;The vial contains 6 ml of solution.&nbsp;It is stored in a lead container.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing authorization holder and manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Bayer AG<\/p>\n\n\n\n<p>51368 Leverkusen<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Bayer AS<\/p>\n\n\n\n<p>Drammensveien 288<\/p>\n\n\n\n<p>NO-0283 Oslo<\/p>\n\n\n\n<p>Norway<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Xofigo is used to treat adults with advanced, castration-resistant prostate cancer\u00a0developing after at least two other cancer treatments except treatment to maintain reduced levels of male sex hormone (hormone therapy), or when other cancer treatment is not possible.\u00a0Castration-resistant prostate cancer is a cancer that does not respond to treatment that reduces male sex hormones.\u00a0Xofigo is only used when the disease has spread to the bones and is causing symptoms (eg pain), but without known spread to other internal organs.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,22504],"tags":[28131,28135,28127,28130,28129,28132,28128,28133,28136,28134],"class_list":["post-32931","post","type-post","status-publish","format-standard","hentry","category-medicines","category-x","tag-benefits-of-radium-ra223dichloride","tag-benefits-of-xofigo","tag-radium-ra223dichloride","tag-radium-ra223dichloride-side-effects","tag-what-is-radium-ra223dichloride","tag-what-is-xofigo","tag-what-radium-ra223dichloride-is-used-for","tag-what-xofigo-is-used-for","tag-xofigo","tag-xofigo-side-effects"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/32931","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=32931"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/32931\/revisions"}],"predecessor-version":[{"id":33382,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/32931\/revisions\/33382"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=32931"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=32931"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=32931"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}