h wall
0.00014
0.51
22
ULI† wall
0.03232
119.58
50
Heart wall
0.00173
6.40
42
Kidneys
0.00320
11.86
36
Liver
0.00298
11.01
36
Lungs
0.00007
0.27
90
Muscle
0.00012
0.44
41
Ovaries
0.00049
1.80
40
Pancreas
0.00011
0.41
43
Red marrow
0.13879
513.51
41
Osteogenic cells
1.15206
4262.60
41
Skin
0.00007
0.27
79
Spleen
0.00009
0.33
54
Testes
0.00008
0.31
59
Thymus
0.00006
0.21
109
Thyroid
0.00007
0.26
96
Urinary bladder wall
0.00403
14.90
63
Uterus
0.00026
0.94
28
Whole body
0.02311
85.50
16
Dosage Forms and Strengths
Xofigo (radium Ra 223 dichloride injection) is available in single-use vials containing 6 mL of solution at a concentration of 1,000 kBq/mL (27 microcurie/mL) at the reference date with a total radioactivity of 6,000 kBq/vial (162 microcurie/vial) at the reference date.
Contraindications
Xofigo is contraindicated in pregnancy.
Xofigo can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Xofigo is not indicated for use in women. Xofigo is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus [see Use in Specific Populations (8.1)].
Warnings and Precautions
Bone Marrow Suppression
In the randomized trial, 2% of patients on the Xofigo arm experienced bone marrow failure or ongoing pancytopenia compared to no patients treated with placebo. There were two deaths due to bone marrow failure and for 7 of 13 patients treated with Xofigo, bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients on the Xofigo arm and 2% on the placebo arm permanently discontinued therapy due to bone marrow suppression.
In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) were similar for patients treated with Xofigo and placebo. Myelosuppression; notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia; has been reported in patients treated with Xofigo. In the randomized trial, complete blood counts (CBCs) were obtained every 4 weeks prior to each dose and the nadir CBCs and times of recovery were not well characterized. In a separate single-dose phase 1 study of Xofigo, neutrophil and platelet count nadirs occurred 2 to 3 weeks after Xofig
