THALOMID® is an immunomodulatory agent indicated for the treatment of patients who are 65 years of age or older with previously untreated multiple myeloma, in combination with melphalan and prednisone (MPT). The following points summarize the updated Product Monograph safety information: 1. Second primary malignancies, in particular acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), have been observed in an ongoing clinical trial in patients with previously untreated multiple myeloma receiving the combination melphalan, prednisone and THALOMID® (MPT). AML and MDS have been rarely reported in the post-market setting. 2. The risk of AML and MDS must be taken into account before initiating treatment with THALOMID® in combination with melphalan and prednisone (MPT). Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies. Read more here.
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