Bayer Xofigo Detailed Information
Xofigo is the first and only FDA-approved targeted alpha therapy used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body.
XOFIGO TREATMENT ROADMAP A PATIENT GUIDE TO HELP START AND STAY ON XOFIGO YOUR DOCTOR PRESCRIBED XOFIGO FOR A REASON 1 • Xofigo is not chemotherapy. It is an alpha-emitting radiopharmaceutical that helps kill prostate cancer cells in the bone.
SCAN TO HEAR XOFIGO PATIENTS SHARE THEIR STORIES
GET THE SUPPORT THAT’S RIGHT FOR YOU 2 • Xofigo can be taken after conventional bone scans and/ or after PSMA PET scans. Ask your doctor what may be needed before starting treatment. Treatment support is a phone call away when and where you need it. FIND A TREATMENT SITE NEAR YOU 3 Xofigo Access Services works with your healthcare provider to: • Help you pay for Xofigo, if you qualify • Assist in finding treatment sites near you • Provide travel assistance to and from treatment • Offer $0 copay for eligible patients • Xofigo is given at licensed treatment facilities with qualified providers across the country. Ask your doctor where you should go for treatment and when to schedule your first appointment.
https://www.xofigo-us.com/patient/patient-videos
Call 1-855-6XOFIGO (1-855-696-3446) to reach Xofigo Access Services (9:00am to 7:00pm ET Monday through Friday).
SCAN TO FIND A TREATMENT SITE CLOSE TO YOU OR CALL 1-855-6XOFIGO
https://www.xofigo-us.com/patient/treatment-site-finder
IMPORTANT SAFETY INFORMATION It is not known if Xofigo is safe and effective in women. Xofigo can harm unborn babies when given to a pregnant woman. 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.
Please see Important Information throughout and page 3 for the consumer brief summary of the full Prescribing Information.
INJECTION radium Ra 223 dichloride (zo-FEEG-oh)
GLOBAL: https://www.xofigo-us.com/pi
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UNDERSTAND YOUR TREATMENT 4
• Before Each Treatment: Get a blood test so your doctor can be sure your blood counts are normal and it is okay for you to receive your injection. • Day of Treatment: 1-min IV injection every 4 weeks for 6 total doses. • After Each Treatment: Once the injection is finished, you can go about your daily activities and be with your loved ones. Make sure you ask for an Appointment Reminder Card to keep track of your appointments or use the space provided. It is important to stay hydrated and monitor your blood cell count. Notify your doctor if you become dehydrated or experience urinary or kidney problems and/or show signs of low blood cell count, such as: • More bleeding or bruising than usual after injury • Catching more colds than usual • Fever • Feeling short of breath • Feeling tired There are additional considerations to keep in mind following treatment with Xofigo.
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EVALUATE YOUR TREATMENT ALONGSIDE YOUR CARE TEAM 5 PSA* levels can change while taking Xofigo (radium Ra 223 dichloride). • If PSA does not change, it does not mean Xofigo is not working to fight cancer cells.
• PSA is not a biomarker for Xofigo therapy effectiveness. • Ask your doctor what to expect while on treatment.
*PSA=prostate-specific antigen.
XOFIGO CAN HELP YOU LIVE LIFE LONGER. Xofigo was studied in a clinical trial with 921 men with mCRPC. The Xofigo-treated men lived 14.9 months while the placebo-treated men lived 11.3 months, in an updated analysis. Xofigo treats symptomatic prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone and whose cancer has spread to the bone but not other parts of the body.
Please see Important Information throughout and page 3 for the consumer brief summary of the full Prescribing Information.
INJECTION radium Ra 223 dichloride (zo-FEEG-oh)
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IMPORTANT SAFETY INFORMATION It is not known if Xofigo is safe and effective in women. Xofigo can harm unborn babies when given to a pregnant woman. 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. BEFORE TAKING XOFIGO, TELL YOUR HEALTHCARE PROVIDER IF YOU: • have bone marrow problems. Xofigo can cause your blood cells counts to go down, including red blood cells, white blood cells, and/or platelets. In a clinical trial, some patients had to permanently discontinue therapy because of bone marrow problems. In addition, there were some deaths and blood transfusions that occurred due to severe bone marrow problems. Your healthcare provider will do blood tests before and during treatment with Xofigo • are receiving any chemotherapy or another extensive radiation therapy • are taking Zytiga ® (also known as abiraterone) with prednisone/prednisolone, as this may increase the risk of bone fractures (breaks) and death • have any other medical conditions WHILE YOU ARE ON XOFIGO: • Make sure you keep your blood cell count monitoring appointments and tell your healthcare provider about any symptoms or signs of low blood cell counts. Report symptoms or signs of shortness of breath, tiredness, bleeding (such as bruising), or infection (such as fever) • Stay well hydrated and report any signs of dehydration (such as dry mouth and increased thirst), or urinary or kidney problems (such as burning when urinating) • There are no restrictions regarding personal contact (visual or physical proximity) with other people after receiving Xofigo • People who are handling fluids such as urine, feces, or vomit of a man taking Xofigo should wear gloves and wash their hands as precaution • Follow good hygiene practices in order to minimize radiation exposure from spills of bodily fluids to household members and caregivers for a period of one week after each injection The most common side effects of Xofigo include: • nausea • diarrhea • vomiting • swelling of the arms or legs (peripheral edema) • low blood cell counts Tell your healthcare provider if you have any side effects that bother you or do not go away. For important risk and use information about Xofigo, please see the Full Prescribing Information at Xofigo-us.com/PI. INDICATION Xofigo ® (radium Ra 223 dichloride) injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body.
IMPORTANT FACTS ABOUT XOFIGO
ABOUT XOFIGO Xofigo is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body. WARNINGS ABOUT XOFIGO Xofigo can cause your blood cell counts to go down, including red blood cells, white blood cells, and/or platelets. In a clinical trial, some patients had to stop therapy because of bone marrow problems. In addition, there were some deaths and blood transfusions that occurred due to severe bone marrow problems. Your healthcare provider will do blood tests before and during treatment with Xofigo.
Please see Important Information throughout and page 3 for the consumer brief summary of the full Prescribing Information.
INJECTION radium Ra 223 dichloride (zo-FEEG-oh)
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IMPORTANT FACTS ABOUT XOFIGO CONT.
WARNINGS ABOUT XOFIGO CONT. It is not known if Xofigo is safe and effective in women. Xofigo can harm unborn babies when given to a pregnant woman. 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. BEFORE STARTING XOFIGO Tell your healthcare provider if you: • Suffer from bone marrow problems (a decrease in blood cell production in the bone marrow). • Your healthcare provider will decide if treatment is right for you • Are receiving any chemotherapy or another broad radiation therapy • Are taking Zytiga ® (also known as abiraterone) with prednisone/ prednisolone, as this may increase the risk of bone fractures (breaks) and death • Have any other medical conditions HOW TO TAKE XOFIGO If Xofigo is right for you, your healthcare provider will refer you to a clinic or facility where healthcare providers or technicians are qualified to give Xofigo. Xofigo is given as a 1-minute IV injection. Over the course of your therapy, you will receive 1 injection every 4 weeks until you reach a total of 6 injections. WHAT YOU SHOULD KNOW WHILE TAKING XOFIGO Blood cell count monitoring appointments are very important. Make sure you keep your appointments, and tell your healthcare provider about any of the following symptoms: shortness of breath, tiredness, bleeding or bruising, or infection (such as a fever). These may be signs or symptoms of low blood cell counts. Stay well hydrated and report any signs of dehydration (such as dry mouth, increased thirst, no urination, or urine that is darker than normal) or kidney problems (such as reduced urine output, shortness of breath, drowsiness, inability to empty your bladder despite the urge to urinate, or swelling of your legs, ankles, or feet). There are no limits regarding personal contact (visual or physical proximity) with other people after receiving Xofigo; however, you should follow good hygiene to reduce radiation contact from spills of bodily fluids to household members and caregivers. Whenever possible, here are some things you should do while receiving Xofigo and for at least 1 week after the last injection: • Be sure to wash your hands well every time you go to the bathroom • Flush the toilet several times after each use • If you spill bodily waste, it should be removed completely and quickly, and you or the person helping you should wash hands thoroughly
WHAT YOU SHOULD KNOW WHILE TAKING XOFIGO • Remember to wear disposable gloves and gowns any time you or your caregiver cleans up bodily waste. Dispose of gloves as directed by the healthcare provider who gave you your Xofigo treatment • If bodily waste gets into clothing, make sure the clothing is quickly washed separate from other clothing • Keep your bathroom area clean 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. POSSIBLE SIDE EFFECTS OF XOFIGO The most common side effects seen in people receiving Xofigo were: • Nausea (feeling sick to your stomach) • Diarrhea • Vomiting • Swelling of the arms or legs, known as peripheral edema • Low blood cell counts Tell your healthcare provider if you have any side effects that bother you or do not go away. The risk information provided here is not comprehensive. How to get more information: • Talk to your healthcare provider or pharmacist • Visit www.xofigo-us.com to obtain the FDA-approved product labeling • Call 1-888-842-2937 You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch, or call 1-800-FDA-1088. Reference: 1. Xofigo ® (radium Ra 223 dichloride) injection [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; December 2019.
© 2023 Bayer. All rights reserved. Bayer, the Bayer Cross, and Xofigo ® are registered trademarks of Bayer.
PP-XOF-US-1688-1 06/23
INJECTION radium Ra 223 dichloride (zo-FEEG-oh) Xofigo
Please see Important Information throughout and page 3 for the consumer brief summary of the full Prescribing Information.
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