II. Indications
-
Osteoporosis Management (Vertebral, non-Vertebral)
- Moderate to High Risk for Fragility Fracture
- Osteoporosis-Related Vertebral Spine Fractures
- Consider in men with high Fracture risk secondary to androgen deprivation therapy (for Prostate Cancer)
- Preferred Osteoporosis agent in Chronic Kidney Disease stage 4 to 5
- Bisphosphonates are contraindicated in advanced renal disease
III. Mechanism
-
Monoclonal Antibody blocks Osteoclast activity
- Acts at nuclear factor kappa B Ligand activator receptor
IV. Dosing
- Dose: 60 mg SQ every 6 months
V. Adverse Effects
- Cost $2600 per year in 2020
- Increased risk of infection
- Jaw Osteonecrosis (rare)
- Atypical Femur Fracture
- Risk of rebound Vertebral Fractures when stopped or dose delayed
- Switch to bisphosphonate when Denosumab course completed
-
Hypocalcemia (2%)
- Reduces Calcium mobilization from bone
- Hypocalcemia may be severe and life threatening
- Higher risk in severe renal disease (esp. Hemodialysis patients)
- Maintain Calcium Supplementation 1000 mg and Vitamin D 400 IU per day while on Denosumab
- Monitor Serum Calcium, Serum Phosphorus and Parathyroid Hormone within 2 weeks of dose change
- Resources
VI. References
- (2023) Presc Lett 30(2): 12
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| prolia (on 7/1/2022 at Medicaid.Gov Survey of pharmacy drug pricing) | ||
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