Nebenwirkungen · Prolia
Prolia 60 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8
HOS-122273 · Präparat HOS-095495
Skin infections In phase III placebo-controlled clinical trials, the overall incidence of skin infections was similar in the placebo and the denosumab groups: in postmenopausal women with osteoporosis (placebo [1.2%, 50 out of 4 041] versus Prolia [1.5%, 59 out of 4 050]); in men with osteoporosis (placebo [0.8%, 1 out of 120] versus Prolia [0%, 0 out of 120]); in breast or prostate cancer patients receiving hormone ablation (placebo [1.7%, 14 out of 845] versus Prolia [1.4%, 12 out of 860]). Skin infections leading to hospitalisation were reported in 0.1% (3 out of 4 041) of postmenopausal women with osteoporosis receiving placebo versus 0.4% (16 out of 4 050) of women receiving Prolia. These cases were predominantly cellulitis. Skin infections reported as serious adverse reactions were similar in the placebo (0.6%, 5 out of 845) and the Prolia (0.6%, 5 out of 860) groups in the breast and prostate cancer studies.
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