TY - CHAP M1 - Book, Section TI - Osteoporosis and Osteomalacia A1 - O’Connell, Mary Beth A1 - Borchert, Jill S. A2 - DiPiro, Joseph T. A2 - Talbert, Robert L. A2 - Yee, Gary C. A2 - Matzke, Gary R. A2 - Wells, Barbara G. A2 - Posey, L. Michael PY - 2017 T2 - Pharmacotherapy: A Pathophysiologic Approach, 10e AB - Content UpdateMay 8, 2019Romosozumab-aqqg (Evenity) Approved for Treatment of Osteoporosis: In April 2019, the US. Food and Drug Administration (FDA) approved romosozumab-apqg to treat osteoporosis in postmenopausal women at high risk of fracture. The monoclonal antibody blocks the effects of the protein sclerostin and primarily stimulates new bone formation, although it also has antiresorptive activity. Two phase 3 clinical trials demonstrated reductions in bone fractures after 12 months when compared to placebo and to oral alendronate 70 mg daily. The labeling contains a boxed warning that it may increase the risk of MI, stroke and cardiovascular death, which may limit use of the drug because the target population is older women who may be at higher cardiovascular risk. Romosozumab-apqg offers a novel anabolic treatment strategy for women who are at high risk of osteoporotic fracture but is expensive, with a U.S. list price reported to be $21,900 for a full 12-month course of injections. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/28 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1163299746 ER -