II. Indications

  1. Osteoporosis Management (Vertebral, non-Vertebral)
    1. Moderate to High Risk for Fragility Fracture
    2. Osteoporosis-Related Vertebral Spine Fractures
  2. Consider in men with high Fracture risk secondary to androgen deprivation therapy (for Prostate Cancer)
  3. Preferred Osteoporosis agent in Chronic Kidney Disease stage 4 to 5
    1. Bisphosphonates are contraindicated in advanced renal disease

III. Mechanism

  1. Monoclonal Antibody blocks Osteoclast activity
    1. Acts at nuclear factor kappa B Ligand activator receptor

IV. Dosing

  1. Dose: 60 mg SQ every 6 months

V. Adverse Effects

  1. Cost $2600 per year in 2020
  2. Increased risk of infection
  3. Jaw Osteonecrosis (rare)
  4. Atypical Femur Fracture
  5. Risk of rebound Vertebral Fractures when stopped or dose delayed
    1. Switch to bisphosphonate when Denosumab course completed
  6. Hypocalcemia (2%)
    1. Reduces Calcium mobilization from bone
    2. Hypocalcemia may be severe and life threatening
      1. Higher risk in severe renal disease (esp. Hemodialysis patients)
    3. Maintain Calcium Supplementation 1000 mg and Vitamin D 400 IU per day while on Denosumab
    4. Monitor Serum Calcium, Serum Phosphorus and Parathyroid Hormone within 2 weeks of dose change
    5. Resources
      1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-risk-severe-hypocalcemia-patients-dialysis-receiving-osteoporosis-medicine-prolia

VI. References

  1. (2023) Presc Lett 30(2): 12

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Cost: Medications

prolia (on 7/1/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
PROLIA 60 MG/ML SYRINGE $1,428.42 per ml