below 40° C (104° F). Store Xofigo in the original container or equivalent radiation shielding.
This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
Follow procedures for proper handling and disposal of radioactive pharmaceuticals [see Dosage and Administration (2.3)].
Patient Counseling Information
Advise patients:
•
To be compliant with blood cell count monitoring appointments while receiving Xofigo. Explain the importance of routine blood cell counts. Instruct patients to report signs of bleeding or infections.
•
To stay well hydrated and to monitor oral intake, fluid status, and urine output while being treated with Xofigo. Instruct patients to report signs of dehydration, hypovolemia, urinary retention, or renal failure / insufficiency.
•
There are no restrictions regarding contact with other people after receiving Xofigo. Follow good hygiene practices while receiving Xofigo and for at least 1 week after the last injection in order to minimize radiation exposure from bodily fluids to household members and caregivers. Whenever possible, patients should use a toilet and the toilet should be flushed several times after each use. Clothing soiled with patient fecal matter or urine should be washed promptly and separately from other clothing. Caregivers should use universal precautions for patient care such as gloves and barrier gowns when handling bodily fluids to avoid contamination. When handling bodily fluids, wearing gloves and hand washing will protect caregivers.
•
Who are sexually active to use condoms and their female partners of reproductive potential to use a highly effective method of birth control during treatment and for 6 months following completion of Xofigo treatment.
Manufactured for:
Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
Manufactured in Norway
Xofigo is a trademark of Bayer Aktiengesellschaft.
© 2013, Bayer HealthCare Pharmaceuticals Inc.
All rights reserved.
Revised: 05/2013
NDC 50419-208-01
6 mL
Xofigo™
Radium Ra 223 dichloride injection
1000 kBq/mL (27 microcurie/mL)
For Intravenous Administration
Sterile
Single-Dose Vial:
Discard Unused Portion
Manufactured for:
Bayer HealthCare
Wayne, NJ 07470
Manufactured in Norway
6000 kBq/vial (162 microcurie/vial) at 5AM CST 912 noon CET) on reference date:
LOT:
EXP:
