Denosumab

Aka: Denosumab, Prolia

II. Indications

  1. Osteoporosis treatment (Vertebral, non-Vertebral)
  2. Osteoporosis-Related Vertebral Spine Fractures
  3. Consider in men with high Fracture risk secondary to androgen deprivation therapy (for Prostate Cancer)

III. Mechanism

  1. Monoclonal Antibody blocks Osteoclasts (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. Risk of rebound Vertebral Fractures when stopped or dose delayed
    1. Switch to bisphosphonate when course completed
  4. 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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