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Risk of serious infections, dermatologic adverse events and suppression of bone turnover, including osteonecrosis of the jaw, with use of Prolia


Amgen has informed physicians of important safety information for Prolia ( Denosumab ) and updates to the Prescribing Information.

Prolia was originally approved by the FDA ( Food and Drug Administration ) in 2010 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. At that time, FDA approved Prolia with a Risk Evaluation and Mitigation Strategy ( REMS ) to ensure the benefits of the drug outweigh the risks of serious infection and dermatological adverse events observed in the pivotal postmenopausal osteoporosis study, as well as the unknown risk of suppression of bone turnover, including osteonecrosis of the jaw, with long-term treatment with Prolia.

In 2011, Prolia was approved for two new indications as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In patients with prostate cancer, Prolia reduced the incidence of vertebral fractures.

Important Information about the risks of Prolia

The REMS associated with Prolia is intended to ensure the benefits of the drug outweigh the risks of: serious infections, dermatologic adverse events, and suppression of bone turnover, including osteonecrosis of the jaw.

Serious infections - In a clinical trial of over 7800 women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the Prolia group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with Prolia. Endocarditis was also reported more frequently in the Prolia-treated subjects.

Dermatologic adverse events - In a clinical trial of over 7800 women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate in the Prolia group compared to the placebo group.

Suppression of bone turnover ( including osteonecrosis of the jaw [ ONJ ] and fracture healing complications ) - Prolia results in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as osteonecrosis of the jaw, atypical fractures and delayed fracture healing. Osteonecrosis of the jaw has been reported in the osteoporosis clinical trial in patients receiving Denosumab. ( Xagena )

Source: FDA, 2011

XagenaMedicine_2011



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