J Clin Pharmacol
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First published on October 22, 2007, doi:10.1177/0091270007309563

The Journal of Clinical Pharmacology 2007;47:1466.

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©© 2007 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270007309563

Article

Pharmacokinetics of Lenalidomide in Subjects With Various Degrees of Renal Impairment and in Subjects on Hemodialysis

Nianhang Chen 1*, Henry Lau 1, Linghui Kong 1, Gondi Kumar 1, Jerome B. Zeldis 1, Robert Knight 1, and Oscar L. Laskin 1

1 Celgene Corporation

* To whom correspondence should be addressed. E-mail: nchen{at}celgene.com.


  Abstract
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 t1/2 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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