Last updated: October 29, 2014
Trade Names: Prolia
Drug Class: Monoclonal antibody to RANK ligand
Preparations: 60 mg vial or prefilled syringe for subcutaneous injection
Dose/Administration: 60 mg by subcutaneous injection every 6 months
Indications: Treatment of postmenopausal osteoporosis; to prevent bone loss in men receiving androgen deprivation therapy for prostate cancer, and women at high risk for fracture receiving aromatase inhibitors for breast cancer
Mechanism of Action: Monoclonal antibody that binds to RANK ligand blocking its interaction with RANK, a receptor on the osteoclast. This prevents osteoclast formation and therefore decreased bone resorption.
Contraindications: Hypersensitivity, pregnancy, hypocalcemia
Precautions: A dental exam and preventive dental work should be performed before starting therapy; administer with calcium and vitamin D. Xgeva is a high dose preparation of denosumab used to treat bone tumors – do not confuse or use with Prolia. Correct hypocalcemia before therapy and monitor calcium if at risk for hypocalcemia.
Pregnancy Risk: X, based on animal studies may cause fetal harm; Amgen has a pregnancy surveillance program for women who fall pregnant on denosumab.
Common: Back pain, musculoskeletal pain, anemia, rash, infections
Uncommon: Hypocalcemia, atypical subtrochanteric femur fractures, osteonecrosis of the jaw, pancreatitis
Drug Interactions: Other immunosuppressants may increase risk of infection; monoclonal antibodies have few drug-drug interactions
Patient Instructions: May increase risk of infections; keep good dental hygiene
Comments: Supplemental calcium and vitamin D are usually co-administered. The optimal duration of treatment is uncertain.
Clinical Pharmacology: Elimination half-life is 25 days
Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361:756-65. PMID: 19671655.
Bone HG, Chapurlat R, Brandi ML, et al. The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension. J Clin Endocrinol Metab 2013;98:4483-92. PMID: 23979955.