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Denosumab (Prolia)

National Drug Monograph

January 2012

VA Pharmacy Benefits Management Services,

Medical Advisory Panel, and VISN Pharmacist Executives

The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current.

Executive Summary:

• Denosumab is an IgG2 monoclonal antibody against RANKL. RANKL is expressed on osteoblasts and binds to RANK on osteoclasts precursors leading to maturation. Neutralizing RANKL inhibits osteoclast formation, function and survival and suppresses bone resorption as evidenced by the reduction in urine and serum markers for bone turnover.

• Denosumab has FDA label indications for the treatment of postmenopausal women with osteoporosis, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

• The dose of denosumab is 60 mg subcutaneously every 6 months.

• Patients should not be hypocalcemic at the time of administration and should receive adequate vitamin D and calcium supplements throughout the course of treatment.

• Denosumab’s efficacy was established in the FREEDOM Trial, a 3-year double-blind, randomized, placebo-controlled clinical trial. After 36 months a new vertebral fracture, the study’s primary end point, was experienced by 2.3% of women assigned to denosumab and 7.2% placebo with a relative risk of 0.32 (95% CI 0.26–0.41), p ................
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