Lenalidomide

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

Lenalidomide is used for the treatment of multiple myeloma and myelodysplastic syndromes particularly when part of chromosome 5q is deleted.

The FDA recommends, but does not require, genetic testing prior to initiating or reinitiating treatment with Lenalidomide.

Excerpt from the Lenalidomide (Revlimid) drug label:
"REVLIMID is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities."

"Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors..."

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the lenalidomide drug label PDF.