TECENTRIQ (atezolizumab)

Starting date:
February 14, 2018
Posting date:
February 14, 2018
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-65990

Healthcare professionals including oncologists, uro-oncologists, urologists, oncology nurses, oncology pharmacists, emergency room staff, and other healthcare professionals providing care to cancer patients, including those working in hospitals, cancer centers, oncology clinics, and pharmacies.

  • Severe cases of myocarditis have been reported in patients being treated with TECENTRIQ (atezolizumab) in clinical trials.  
  • Healthcare professionals are advised to:
    • monitor patients receiving TECENTRIQ for signs and symptoms of myocarditis. 
    • withhold TECENTRIQ therapy in patients with Grade 2 myocarditis. 
    • permanently discontinue TECENTRIQ treatment in patients with Grade 3 or 4 myocarditis.
    • administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to TECENTRIQ treated patients who develop myocarditis.
  • The Canadian Product Monograph has been updated to include this new safety information.

Severe cases of myocarditis have been reported in patients receiving TECENTRIQ treatment.

TECENTRIQ (atezolizumab), concentrate for solution for infusion, 60 mg / mL in 20 mL single use vials.

TECENTRIQ has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit.

TECENTRIQ (atezolizumab) is indicated 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.

As of February 20, 2017, a cumulative analysis of the company's safety database, which includes data from clinical trials and the post-marketing setting, identified 2 non-fatal cases of myocarditis, including one case with biopsy confirmation. No Canadian cases of myocarditis related to TECENTRIQ treatment have been identified as of February 2017. Approximately 8,000 patients in clinical trials and 5,000 patients in the post-market setting have been exposed to TECENTRIQ as of November 2016.

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 patients have tried chemotherapy and it did not work or is no longer working.

In some patients, TECENTRIQ has been associated with the risk of developing myocarditis. Myocarditis is an inflammation of the heart muscle, leading to possible reduction in the heart's pumping function and to possible irregular heartbeat.

Patients should contact their healthcare professional if they develop the following signs and symptoms during treatment with TECENTRIQ:

  • Chest pain
  • Irregular heartbeat
  • Shortness of breath, at rest or during physical activity
  • Fluid retention with swelling of legs, ankles and feet
  • Decreased exercise tolerance

Patients and caregivers should discuss any questions or concerns about this information with their healthcare professional.

Patients receiving TECENTRIQ should also inform their healthcare professional if they experience any other side effects.

Healthcare professionals are advised to:

  • monitor patients receiving TECENTRIQ for signs and symptoms of myocarditis.
  • withhold TECENTRIQ therapy in patients with Grade 2 myocarditis.
  • permanently discontinue TECENTRIQ treatment in patients with Grade 3 or 4 myocarditis.
  • administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to TECENTRIQ treated patients who develop myocarditis.

Health Canada in collaboration with Hoffmann-La Roche Limited has updated the TECENTRIQ Product Monograph. 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 update will be further distributed through the MedEffect™ e-Notice email notification system.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of myocarditis 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

Hany Moselhi, MD
Vice President, Medical Affairs
Hoffmann-La Roche Limited

For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.

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