Pharm

Denosumab

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Denosumab, Prolia, Xgeva

  • See Also
  1. Osteoporosis
  2. Osteoporosis Management
  3. Metastatic Cancer involving Long Bones
  • Indications
  1. Osteoporosis (Prolia)
    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
  2. Bone Metastases and other cancer related bone complications (Xgeva)
    1. Multiple Myeloma or bone metastases from solid tumors prevention of skeletal-related events
    2. Nonoperative giant cell tumor of bone in adults and skeletally mature teens
    3. Hypercalcemia of Malignancy refractory to bisphosphonate therapy
  • Medications
  1. Denosumab (Prolia)
    1. Supplied as 60 mg/mL clear or pale yellow solution in a single-dose prefilled syringe
  2. Denosumab (Xgeva)
    1. Supplied as 120 mg/1.7 mL (70 mg/mL) clear or pale yellow solution in a single-dose vial
  3. Biosimilars
    1. More than a dozen Denosumab Biosimilars are available as of 2025
    2. Biosimilar costs are 50% of trade name
    3. FDA required to have similar safety, purity and potency to trade name product
    4. Exercise caution in substitution (not all Biosimilars are interchangeable)
    5. (2025) Presc Lett 32(12): 71
  • Mechanism
  1. Monoclonal Antibody blocks Osteoclast activity
    1. Acts at nuclear factor kappa B Ligand activator receptor
  • Dosing
  1. Osteoporosis (Prolia)
    1. Dose: 60 mg SQ every 6 months
  2. Bone Metastases (Xgeva)
    1. Dose 120 mg SQ every 4 weeks
  • 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
  • Resources
  1. Denosumab (Prolia)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88
  2. Denosumab (Xgeva)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=628f0998-1206-4001-aeee-18133aa9f3bf
  • References
  1. (2023) Presc Lett 30(2): 12