Radium Ra 223 Dichloride and Myelosuppression

A randomized clinical trial reported that 2% of the patients receiving radium Ra 223 experienced bone marrow failure or ongoing pancytopenia, including 2 deaths due to bone marrow failure. Myelosuppression including thrombocytopenia, neutropenia, pancytopenia, and leukopenia have been reported in patients receiving this agent. Patients should have a baseline hematologic evaluation, as well as another evaluation prior to every dose. The absolute neutrophil count (ANC) prior to the first administration should be >= 1.5 x 10^9/L, the platelet count should be >= 100 x 10^9/L, and hemoglobin should be >= 10 g/dL; and before subsequent administrations, the ANC should be >= 1 x 10^9/L and the platelet count >= 50 x 10^9/L. Discontinue treatment if after the last administration there is no recovery of these values within 6 to 8 weeks, despite supporting care and in those patients experiencing life-threatening complications. Caution is advised in patients with preexisting hematologic issues.

In a randomized clinical trial, patients on the radium Ra 223 dichloride arm experienced bone marrow failure or ongoing pancytopenia compared to no patients treated with placebo. Myelosuppression; notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia; has been reported in patients treated with radium Ra 223 dichloride. Hematologic evaluation of patients must be performed at baseline and prior to every dose of radium Ra 223 dichloride. Before the first administration of radium Ra 223 dichloride, the absolute neutrophil count (ANC) should be >= 1.5 x 10^9/L, the platelet count >= 100 x 10^9/L and hemoglobin >= 10 g/dL. Before subsequent administrations of radium Ra 223 dichloride, the ANC should be >= 1 x 10^9/L and the platelet count >= 50 x 10^9/L. Patients with evidence of compromised bone marrow reserve should be monitored closely and provided with supportive care measures when clinically indicated. It is recommended to discontinue the use of radium Ra 223 dichloride in patients who experience life-threatening complications despite supportive care for bone marrow failure.