Can Evenity (romosozumab) be used in patients with impaired renal function undergoing renal dialysis?

Use of Evenity (Romosozumab) in Patients on Renal Dialysis

Evenity (romosozumab) can be used in patients undergoing renal dialysis without dose adjustment, as it is not eliminated through the kidneys and the FDA label specifically states no dose adjustment is required in patients with renal impairment or receiving dialysis. 1

Pharmacology and Renal Considerations

Romosozumab is a humanized monoclonal antibody that inhibits sclerostin, increasing bone formation while decreasing bone resorption. Unlike many other medications, romosozumab does not require dose adjustment in renal impairment because:

• It is not eliminated through the kidneys but rather follows typical monoclonal antibody clearance pathways
• The FDA label explicitly states: "No dose adjustment is required in patients with renal impairment" 1
• The medication has a molecular weight of approximately 149 kDa, making it too large for significant renal filtration

Evidence for Use in Dialysis Patients

Recent research supports the use of romosozumab in hemodialysis patients:

• A 2023 observational study of 13 hemodialysis patients with osteoporosis showed significant bone mineral density (BMD) improvements after 12 months of romosozumab treatment: +9.0% at lumbar spine, +2.5% at total hip, and +4.7% at femoral neck 2
• A 2025 comparative study between romosozumab and denosumab in hemodialysis patients demonstrated superior efficacy of romosozumab for improving lumbar spine BMD (14.6% vs. 6.3% increase) 3
• Case reports have documented successful treatment of severe osteoporosis in hemodialysis patients with romosozumab 4, 5

Special Considerations for Dialysis Patients

While romosozumab can be used in dialysis patients, several precautions should be taken:

1. Calcium monitoring: Patients on dialysis are at greater risk of developing hypocalcemia 1

   • Monitor calcium concentrations regularly
   • Provide adequate calcium and vitamin D supplementation

2. Cardiovascular risk assessment:

   • In a 2024 study, 2% of patients experienced cardiovascular events during romosozumab treatment 6
   • Consider cardiovascular history when selecting treatment options

3. Concomitant medications:

   • When used with calcium-sensing receptor agonists (for secondary hyperparathyroidism), close monitoring of serum calcium is essential 5

Administration Protocol for Dialysis Patients

• Standard dose: 210 mg subcutaneously once monthly (two 105 mg injections) 1
• Duration: Typically 12 months, followed by another anti-resorptive agent like denosumab 2
• Timing: Can be administered regardless of dialysis schedule (no removal by dialysis)
• Supplementation: Ensure adequate calcium and vitamin D supplementation

Efficacy Predictors in Dialysis Patients

Romosozumab may be particularly effective in dialysis patients with:

• Low baseline bone mineral density at total hip and femoral neck 2
• High baseline levels of bone turnover markers (particularly TRACP-5b) 2
• No prior treatment with other anti-osteoporosis agents, especially denosumab 6

In conclusion, Evenity (romosozumab) can be safely and effectively used in patients on renal dialysis without dose adjustment, but requires careful monitoring of calcium levels and consideration of cardiovascular risk factors.