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General and Risk Management, Patient Safety (including: medication errors, quality control)
Change of dose of lenalidomide in relation to renal function: following the SPC
  1. V. Ortoll-Polo,
  2. R. Rodriguez-Carrero,
  3. I. Zapico,
  4. P. Puente
  1. 1Hospital San Agustin, Hospital Pharmacy, Aviles, Spain

Abstract

Background Lenalidomide was authorised in 2007 by EMA for treatment of multiple myeloma (MM) and is also used for myelodysplastic syndrome (MS) off label. Since lenalidomide is mainly excreted through the urine, renal function monitoring and dose adjustments are required in renal impairment.

Purpose To evaluate modifications in the renal function (RF) in patients with MM and MS and to assess lenalidomide dose modifications in relation to changes in renal clearance as recommended in the summary of product characteristics (SPC).

Materials and methods Observational retrospective study of treatments started in the period between May 2008 and September 2010. RF was classed in four groups: normal (NRF, ClCr: >50 ml/min), moderate worsening (MWRF, ClCr=30–50 ml/min), serious worsening (SWRF, ClCr<30 ml/min without dialysis) and terminal (TRF, ClCr <30 ml/min with dialysis). The lenalidomide SPC recommends dose modifications for the three latter classes.

Results Sixteen patients were found, 14 treated for MM and 2 MS. Male/female ratio was 1:1 and median age 68.3 years (CI 95% 63.1 to 73.4). A total of 98 cycles were administrated, with a median of six cycles per patient (2–21). Renal function was normal in 40 patient cycles, but dose modifications were made in 36.3% due to other adverse effects. Renal function was moderately worse in 49 cycles; dose reduction and spacing out were the most frequent adjustments made (18.4% each one), and no modification was made in 53.1% of cycles. TRF appeared in eight cycles, no adjustment was made in three, the dose was reduced and the interval increased in two (as the SPC recommends) and other modifications were made in three. Dialysis was not needed in any case.

Conclusions As renal damage is often present in multiple myeloma patients (most of our study population), it is vital to monitor kidney function to adjust doses of renally-cleared drugs such as lenalidomide. Despite this, half of the doses that might have been adjusted, were not modified. This would be a potential intervention point for the hospital pharmacist, in order to improve patient safety.

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