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Home > Health, Menopause and Perimenopause Treatments, Osteoporosis > New Osteoporosis Treatment Approved

New Osteoporosis Treatment Approved

Last week, Prolia™ (denosumab) was approved 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.  In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, non-vertebral and hip fractures.  

 Prolia is the first and only RANK ligand inhibitor approved by the FDA.  Prolia has a Risk Evaluation and Mitigation Strategy (REMS) that consists of a Medication Guide and a Dear Healthcare Professional Letter.  The manufacturer, Amgen, is also launching a voluntary program to monitor the long-term safety of Prolia and enhance the quality of data collected in the postmarketing setting.  This program is called the Prolia Post Marketing Active Safety Surveillance Program and is intended to collect information about pre-specified adverse events of special interest that may be reported by patients.  More information about this program may be found at www.proliasafety.com or by calling Amgen Medical Information at 1-800-772-6436.

 Prolia Important 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.

 In the 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-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as osteonecrosis of the jaw (ONJ), atypical fractures, and delayed fracture healing.  ONJ has been reported in patients with Prolia.  Patients should be monitored for these adverse outcomes.  The most common adverse reactions (> 5% and more common than placebo) were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.  Pancreatitis has also been reported with Prolia.

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  1. June 8th, 2010 at 08:28 | #1