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This application is a service of the Singapore Government.

Health Sciences Authority

TECENTRIQ® (atezolizumab) and new safety concern of immune-related nephritis

Please note that only an abstract of the Dear Healthcare Professional Letter (DHCPL) is provided here. For instructions on how to access the entire DHCPL, please click here.

Roche Singapore Pte Ltd would like to inform healthcare professionals of the new safety concern of immune-related nephritis associated with Tecentriq® (atezolizumab). Immune-related nephritis is a rare complication of checkpoint inhibitors therapy, with the most commonly reported underlying pathology being acute tubulo-interstitial nephritis. The most common presentation of immune-related nephritis includes asymptomatic increase in creatinine levels. In the absence of alternative etiologies (e.g. prerenal and postrenal causes, concomitant medications), immune-related nephritis is defined as a renal dysfunction requiring steroids treatment and/or confirmed by biopsy. Healthcare professionals are advised to monitor patients for changes in renal function and to withhold Tecentriq® for moderate (Grade 2) immune-related nephritis, and permanently discontinue Tecentriq® for severe nephritis (Grade 3 and 4). It is also recommended to administer corticosteroids and/or additional immunosuppressive agents as clinically indicated. Roche Singapore Pte Ltd is working with HSA to update the Singapore package insert for Tecentriq® to include the risk of immune-related nephritis. Please refer to the letter for details.