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Award-Winning Actress Blythe Danner and Amgen Launch Act 2 Reduce Fractures™ Educational Campaign
Date:8/25/2011

break down bone).

Prolia is approved in the United States (U.S.) 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.

Prolia is administered as a single subcutaneous injection of 60mg once every six months. For further information on Prolia, including the full prescribing information and medication guide, please visit: www.prolia.com.  

Important U.S. Safety Information Prolia is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Hypocalcemia may worsen, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D. Patients receiving Prolia should not receive XGEVA®, as both Prolia and XGEVA contain the same active ingredient, denosumab.

In the Phase 3 pivotal study, serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Endocarditis was reported more frequently in the Prolia-treated patient group. Epidermal and dermal adverse events such as dermatitis, rashes, and eczema have been reported. Discontinuation of Prolia should be considered if severe symptoms develop.

Prolia resulted in significant suppression of bone remodeling. The significance of these findings is unknown. The long-
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SOURCE Amgen
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