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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