XOFIGO
Generic Name/API: radium Ra 223 dichloride
Manufacturer: Bayer HealthCare
Dosage Forms & Strength & Pack Size:
Single-dose vial at a concentration of 1,100 kBq/mL (30 microcurie/mL) at the reference date with a total radioactivity of 6,600 kBq/vial (178 microcurie/vial) at the reference date. (3)
Storage:
Store at room temperature, below 40° C (104° F). Store Xofigo in the original container or equivalent radiation shielding.
Radiation Emergency Medical Management. [REMM/National Library of Medicine Website.] http://www.remm.nlm.gov/int_contamination.htm#blockingagents
International Commission on Radiological Protection, ICRP Publication 128, 2015. http://www.icrp.org/publication.asp?id=ICRP Publication 128
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)].
Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. (1)
Bone Marrow Suppression: Measure blood counts prior to treatment initiation and before every dose of Xofigo. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after treatment. Monitor patients with compromised bone marrow reserve closely. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care measures.
Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone: Xofigo is not recommended in combination with abiraterone acetate plus prednisone/prednisolone.
Embryo-Fetal Toxicity: Xofigo can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception
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