Journal
JOURNAL OF CLINICAL PHARMACOLOGY
Volume 47, Issue 12, Pages 1466-1475Publisher
WILEY
DOI: 10.1177/0091270007309563
Keywords
lenalidomide; pharmacokinetics; renal impairment; hemodialysis
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The present study investigated the effect of renal impairment and hemodialysis on the pharmacokinetics of lenalidomide following a single 25-mg oral dose in 30 subjects aged 39 to 76 years. A single 25-mg dose was well tolerated by renally impaired subjects. Renal impairment did not alter the oral absorption, protein binding, or non-renal elimination of lenalidomide. Mean urinary recovery Of unchanged lenalidomide was 84% of the dose in subjects with normal renal function (creatinine clearance [CLCr] > 80 mL/min), and it declined to 69%, 38%, and 43% in subjects with mild (50 <= CLCr <= 80 mL/min), moderate (30 <= CLCr < 50 mL/min), and severe (CLCr < 30 mL/min) renal impairment, respectively. The differences in pharmacokinetic parameters between normal renal function and mild renal impairment were minor to modest (11%-32%). As renal impairment progressed to moderate, severe, or end-stage renal disease, total and renal lenalidomide clearance decreased drastically, area under the concentration-time curve increased by approximately 185% to 420%, and t(1/2) was prolonged by approximately 6 to 12 hours. A 4-hour hemodialysis removed 31% of lenalidomide in the body. Therefore, lenalidomide dose adjustments should be considered for patients with CLCr < 50 mL/min, and the recommendations are given for the starting doses.
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