The FDA has communicated a pharmacovigilance requirement to Janssen regarding adverse event reporting associated with TALVEY® (talquetamab-tgvs). The pharmacovigilance requirement is specifically regarding instances of wrong drug error or the potential for wrong drug error, including but not limited to administration of the wrong drug, incorrect association with step-up dosing schedules, intercepted errors (e.g., a wrongly prepared medicine that was not administered), and circumstances capable of leading to a wrong drug error.

Click here to access TALVEY pharmacovigilance Safety alert.