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Xofigo®(radium-223 dichloride)

Safety

Safety profile of Xofigo + BSC was comparable to placebo + BSC

In the phase 3 ALSYMPCA trial, the rates of AEs were similar with Xofigo + BSC vs placebo + BSC

Rate of AEs:

^{ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. The safety population included 600 patients in the Xofigo + BSC group and 301 patients in the placebo + BSC group.}

The most frequently observed adverse reactions (≥ 10%) in patients receiving Xofigo were diarrhoea, nausea, vomiting, thrombocytopenia and bone fracture
The most serious adverse reactions were thrombocytopenia and neutropenia
Xofigo increases the risk of bone fractures. In clinical studies, concurrent use of bisphosphonates or denosumab reduced the incidence of fractures in patients treated with Xofigo

For the full list of AEs, please refer to the SMPC link below:

Summary of Product Characteristics

Treatment considerations

Chemotherapy may be used after Xofigo^*

Patient considerations

Low incidence of Grade 3–4 vomiting
Can be administered without the need for steroids^†

^{* The haematological safety profiles for patients receiving chemotherapy after Xofigo were similar to those seen in patients receiving chemotherapy after placebo.}

^{† Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Concomitant use of steroids may further increase the risk of fracture.}

Xofigo®▼ (radium-223 dichloride) | Dosing & Administration

Discover dosing of Xofigo®.

Xofigo Prescribing Information

PP-XOF-IE-0131-1, February 2026

Xofigo®▼ | Patient identification & Treatment sequencing

Explore Patient identification & Treatment sequencing with Xofigo®▼ (radium-223 dichloride).

Xofigo Prescribing Information

PP-XOF-IE-0128-1, January 2026

About Xofigo®▼ (radium-223 dichloride)

Access key information about Xofigo®.

Xofigo Prescribing Information

PP-XOF-IE-0127-1, January 2026

Abbreviations

AE,

^{adverse event;}^BSC,^{best standard of care;}^mCRPC,^{metastatic castration-resistant prostate cancer.}

PP-XOF-IE-0130-1 | February 2026

^{▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professional are asked to report any suspected adverse reactions.}

References

1
Parker C, et al. N Engl J Med. 2013;369(3):213-223.
2
Xofigo®(radium-223 dichloride): Summary of Product Characteristics.
3
O’Sullivan JM, et al. Eur Urol Oncol. 2019; doi:10.1016/j.euo.2019.02.007.
4
Sartor O, et al. Prostate. 2016;76:905–916.
5
Data on File. XOF-001. Bayer. 2016.