Other safety alerts
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| Canada: TECENTRIQ (atezolizumab) - Risk of immune-related nephritis |
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Health Canada announces that cases of immune-related nephritis have been reported in patients receiving TECENTRIQ (atezolizumab) for the treatment of urothelial and lung cancers.
Immune-related nephritis is defined as renal dysfunction in the absence of alternative etiologies (e.g., prerenal, postrenal causes, or concomitant medications). It is confirmed by biopsy and requires corticosteroid treatment. It is a rare complication of checkpoint inhibitors (CPI) therapy with the most common reported underlying pathology being acute tubulo-interstitial nephritis (ATIN). The most common presentation is asymptomatic increase in creatinine levels.
As of 31 May 2018, there were a total of 28 cases including 13 biopsy confirmed cases in which atezolizumab played a potential role in the development of nephritis. Two of the 28 cases were reported in Canada. Both patients recovered with corticosteroid treatment.
Healthcare professionals are advised to:
- Monitor kidney function during treatment with TECENTRIQ and withhold treatment in patients who develop moderate (Grade 2) immune-related nephritis.
- Permanently discontinue TECENTRIQ treatment in patients with severe (Grade 3 and 4) immune-related nephritis.
- Administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to patients treated with TECENTRIQ who develop immune-related nephritis.
- Refer patients treated with TECENTRIQ who develop immune-related nephritis to a kidney specialist; consider renal biopsy and other supportive measures as indicated.
Health Canada is currently working with the manufacturer to include the risk of immune-related nephritis in the TECENTRIQ Canadian Product Monograph.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../67782a-eng.php
In Hong Kong, Tecentriq Concentrate For Solution For Infusion 1200mg/20ml (HK-65567) is a pharmaceutical product registered by Roche Hong Kong Limited (Roche HK), and is a prescription-only medicine. So far, the Department of Health (DH) has received 16 cases of adverse drug reaction related to atezolizumab, but these cases are not related to immune-related nephritis.
Related news was previously issued by Singapore Health Sciences Authority (HSA), and was posted on the Drug Office website on 31 Aug 2018. Letters to inform local healthcare professionals of the risk of immune-related nephritis were issued by DH on the same day. Roche HK has recently submitted an application to update the package insert of the product, including the safety information on immune-related nephritis. DH will work with Roche HK to update the product's safety information and will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Wednesday, Sep 19, 2018
Issued at HKT 16:00
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