Pharm

Denosumab

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Denosumab, Prolia

  • See Also
  1. Osteoporosis
  2. Osteoporosis Management
  • 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
  • Mechanism
  1. Monoclonal Antibody blocks Osteoclast activity
    1. Acts at nuclear factor kappa B Ligand activator receptor
  • Dosing
  1. Dose: 60 mg SQ every 6 months
  • 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
  • References
  1. (2023) Presc Lett 30(2): 12