Drug Interaction Report

MONITOR CLOSELY: The risk of rhabdomyolysis may be increased during coadministration of lenalidomide with HMG-CoA reductase inhibitors (statins). The mechanism is unknown but may involve additive pharmacodynamic effects. The European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) evaluated 23 cases of rhabdomyolysis associated with lenalidomide; concomitant use of statins occurred in 4 cases. All cases were considered serious and patients recovered after both drugs were discontinued. Rhabdomyolysis occurred within 5, 14 and 19 days after initiation of lenalidomide in 3 cases and within 8 days after increased lenalidomide dosage in the fourth case.

MANAGEMENT: European product labeling recommends caution and increased clinical and biological monitoring if lenalidomide is used in combination with statins, especially during the first several weeks of treatment. All patients treated with statins should be advised to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.