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Xofigo combinations raise fracture risk
  • By Lee Hye-seon
  • Published 2018.07.19 13:59
  • Updated 2018.07.19 13:59
  • comments 0

Combinations using Bayer Korea’s prostate cancer treatment Xofigo Inj. (ingredient: radium223 dichloride) with abiraterone, prednisone, or prednisolone raise fracture risk, the government warned Thursday.

Bayer Korea’s Xofigo Inj.

The Ministry of Food and Drug Safety said it would order the drugmaker to add the warning to the treatment’s usage precautions. The ministry’s measure came after France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the European Commission banned the mixing of Xofigo with abiraterone, prednisone, or prednisolone.

The contraindication of the combo therapies stemmed from an interim analysis of clinical trials in patients with asymptomatic or mild castration-resistant prostate cancer with no previous chemotherapy or those with progressive disease accompanying bone metastasis.

Fractures and death risks increased with the Xofigo combinations than the placebo combinations. Fractures occurred less frequently when Xofigo was combined with bisphosphonate or denosumab, a treatment for osteoporosis.

The warnings will also include that the safety and efficacy of Xofigo in combination with second-generation androgen receptor antagonists, such as enzalutamide, have not been established.

The food and drug safety ministry will collect opinions from the pharmaceutical industry about changes in Xofigo’s usage precautions until Aug. 1.

lhs@docdocdoc.co.kr

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