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.

Adverse Effects
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

Cost: $$$$$

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.

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