Tecentriq (Atezolizumab) Warning [Canada]


Canada FlagCanada/Ottawa: Tecentriq (Atezolizumab) Warning [Canada]Health Canada, a Canadian health regulatory authority, warns patients, physicians and other healthcare professionals that Tecentriq (Atezolizumab) may increase the risk of Myocarditis, a serious health and safety hazards. HCSC: http://ht.ly/fJC630iwzoN

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/65990a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following drug products are subject to this recall:

  • Tecentriq (Atezolizumab) concentrate for solution for infusion, 60 mg / mL in 20 mL single use vials.

Please consult the photograph above for details of the product’s packaging, design and retail presentation.

==> No barcodes, UPCs, DINs, item numbers or other identification numbers were listed with this recall notification.

According to Health Canada, severe cases of Myocarditis have been reported in patients being treated with Tecentriq (Atezolizumab) in clinical trials.

Physicians and other healthcare professionals are advised to do the following:

  • Monitor patients receiving Tecentriq (Atezolizumab) 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.

Tecentriq (Atezolizumab) has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit.

Background:
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 two (2) non-fatal cases of Myocarditis, including one (1) case with biopsy confirmation. No Canadian cases of Myocarditis related to Tecentriq (Atezolizumab) 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 (Atezolizumab) as of November 2016.

Patients should contact their healthcare professional if they develop any of the following signs and symptoms during treatment with Tecentriq (Atezolizumab):

  • 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

If you are taking Tecentriq (Atezolizumab) or are a caregiver of a person who is taking this medication, please discuss any questions or concerns about this information with your physician or other healthcare professional.

If you have any questions about this warning notification, please contact Hoffmann-La Roche Limited toll free at 1-888-762-4388. Alternatively, you can also e-mail the company at mississauga.drug_safety@roche.com.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Hoffmann-La Roche Limited, please search for “Hoffmann-La Roche” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-65990
Recalls Direct RIN: 9806-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product in Canada [external: new window opens]:
===>
https://www.canada.ca/en/services/health/report-health-safety-concern.html
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==>
http://recherche-search.gc.ca/rGs/s_r?cdn=canada&st=a&num=10&langs=eng&st1rt=0&s5bm3ts21rch=x&1s_s3t2s21rch=healthycanadians.gc.ca%2Frecall-alert-rappel-avis%2F&as_q=&wb-srch-sub=Search+alerts#wb-land

We welcome your feedback:
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E. & O. E.

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