TECENTRIQ® (atezolizumab) - Risk of Immune-Related Nephritis
- Starting date:
- September 18, 2018
- Posting date:
- September 18, 2018
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Biologic/vaccine
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- Healthcare Professionals
- Identification number:
- RA-67782
Audiences
Healthcare professionals including oncologists, pulmonologists/respirologists, uro-oncologists, urologists, nephrologists, emergency room staff, oncology nurses, oncology pharmacists, and other healthcare professionals providing care to cancer patients, including those working in hospitals, cancer centers, oncology clinics and pharmacies
Key messages
- Cases of immune-related nephritis have been reported in patients receiving TECENTRIQ (atezolizumab) for the treatment of urothelial and lung cancers.
-
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.
Issue
Cases of immune-related nephritis have been reported in cancer patients receiving TECENTRIQ treatment. 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.
Products affected
TECENTRIQ (atezolizumab), concentrate for solution for infusion, 60 mg / mL in 20 mL single use vials.
Background information
TECENTRIQ has received market authorization in Canada for use in the following clinical settings:
1. Locally Advanced or Metastatic Urothelial Carcinoma
TECENTRIQ has been issued marketing authorization with conditions, meaning that that conditions apply, pending the results of studies to verify its clinical benefit for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- Have disease progression during or following platinum-containing chemotherapy
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy
2. Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
TECENTRIQ has been issued marketing authorization for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
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 May 31, 2018, a comprehensive analysis of the company clinical safety database, which collects data from various sources such as clinical studies, market research, patient support programs, literature, and post-market studies, identified 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, but were not biopsy confirmed. Both patients recovered with steroid treatment. An estimated 17,215 and 20,783 patients worldwide have been exposed to TECENTRIQ (atezolizumab) in clinical trial and post-market settings respectively, as of May 17, 2018.
Who is affected
Information for consumers
TECENTRIQ is used to treat a type of bladder cancer called urothelial carcinoma that cannot be removed by surgery or has spread to other parts of the body. TECENTRIQ is used after platinum-based chemotherapy has been tried and did not work or is no longer working.
TECENTRIQ is also used to treat a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body. TECENTRIQ is used after platinum-based chemotherapy has been tried and did not work or is no longer working.
TECENTRIQ has been associated with the risk of developing immune-related nephritis in some patients. Immune-related nephritis is the inflammation of the kidney caused by immune system disorders.
Patients and caregivers should contact their healthcare professional to get information on how they will be monitored while taking this drug as well as for more details on this new safety information.
Patients receiving TECENTRIQ should also inform their healthcare professional if they experience any other side effects.
Information for healthcare professionals
Healthcare professionals are advised to:
- Monitor patients for immune-related nephritis and withhold the TECENTRIQ treatment in patients who develop moderate (Grade 2) immune-related nephritis.
- Permanently discontinue the TECENTRIQ treatment in patients with severe (Grade 3 and 4) immune-related nephritis.
- Initiate treatment with corticosteroids and/or additional immunosuppressive agents as clinically indicated to patients 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.
Action taken by Health Canada
Health Canada, in collaboration with Hoffmann-La Roche Limited, will update the TECENTRIQ Product Monograph to include information related to the risk of immune-related nephritis. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system.
Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of immune-related nephritis or other serious or unexpected side effects in patients receiving TECENTRIQ should be reported to Hoffmann-La Roche Limited or Health Canada.
Hoffmann-La Roche Limited
Drug Safety Department
7070 Mississauga Road
Mississauga, Ontario, L5N 5M8
Toll free: 1-888-762-4388
Fax: 905-542-5864
E-mail: mississauga.drug_safety@roche.com
To correct your mailing address or fax number, contact Hoffmann-La Roche Limited.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738