What are the dosing recommendations for Crestor (rosuvastatin) in patients with impaired renal function?

Rosuvastatin Dosing in Renal Impairment

For patients with severe renal impairment (CrCl <30 mL/min/1.73 m²) not on hemodialysis, the recommended starting dosage of rosuvastatin is 5 mg once daily and should not exceed 10 mg once daily. 1

Dosing Recommendations Based on Renal Function

• Normal to Moderate Renal Impairment (CrCl ≥30 mL/min/1.73 m²):

  • No dosage adjustment necessary 2, 1
  • Standard dosing range of 5-40 mg daily can be used 1

• Severe Renal Impairment (CrCl <30 mL/min/1.73 m²):

  • Start with 5 mg once daily 1
  • Maximum dose should not exceed 10 mg once daily 1, 2
  • Careful monitoring is recommended due to increased risk of myopathy 3

Special Considerations

• Asian patients require lower starting doses (5 mg) due to increased plasma concentrations, which is especially important when combined with renal impairment 1

• Patients on hemodialysis should follow the same recommendations as those with severe renal impairment (start at 5 mg, maximum 10 mg daily) 1, 3

• Rosuvastatin has less renal elimination compared to some other medications, but dose adjustment is still necessary in severe renal impairment to avoid adverse effects 4, 3

Drug Interactions Requiring Additional Dose Adjustments

When using rosuvastatin in patients with renal impairment, be aware of these additional dosing restrictions when used with:

• Cyclosporine: Do not exceed 5 mg once daily 1
• Gemfibrozil: Avoid concomitant use; if necessary, initiate at 5 mg once daily and do not exceed 10 mg daily 1
• Various antiviral medications (including atazanavir/ritonavir, lopinavir/ritonavir): Initiate at 5 mg once daily and do not exceed 10 mg daily 1

Monitoring Recommendations

• Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin 1
• Monitor for signs of myopathy, which may be more common in patients with renal impairment 3
• Regular assessment of renal function is recommended, especially in patients with fluctuating renal function 5

Clinical Considerations

• Rosuvastatin is primarily eliminated through biliary excretion rather than renal clearance, but plasma concentrations are still higher in patients with severe renal impairment 4, 3

• The risk of myopathy may be increased in patients with severe renal impairment, necessitating the lower maximum dose of 10 mg daily 1, 3

• When calculating renal function for drug dosing, the Cockcroft-Gault formula is often recommended for consistency with FDA labeling, though newer formulas like CKD-EPI may provide more accurate estimates of GFR 6

• Compared to other statins, rosuvastatin has a favorable drug interaction profile as it is not dependent on cytochrome P450 3A4 metabolism 4, 3