Health professional risk communication

Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic

Starting date:
September 22, 2021
Posting date:
October 4, 2021
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Important Safety Information, Supply
Audience:
Healthcare Professionals
Identification number:
RA-76573

Last updated: 2021-10-04

Audiences

Healthcare professionals including infectious disease physicians, emergency room (ER) physicians, internal medicine physicians, critical care physicians, respirologists, pharmacists, hospital pharmacy departments, and chiefs of medicine in hospitals.

Key messages

  • On July 30, 2021, sotrovimab for injection, a monoclonal antibody, was authorized for use in Canada in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
  • Sotrovimab is indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death.
  • At this time, GlaxoSmithKline is providing sotrovimab with European French and English labelling, in order to expedite the distribution of the product.  Sotrovimab supply with Canadian-specific labelling information is anticipated in 2022.
  • Healthcare professionals are advised that:
    • Important Canadian-specific information is absent from the vial and carton labels (see the Information for Healthcare Professionals section).
    • The Canadian Product Monograph, which is available in French and English on Health Canada’s Drug Product Database, www.gsk.ca or www.sotrovimabinfo.com should be used for complete product information.
    • The Canadian-specific labelling information, including the Product Monograph, can be accessed at www.sotrovimabinfo.com and https://covid-vaccine.canada.ca/or by scanning the QR code found on the outer carton or package leaflet.
    • The expiry date printed on the carton and vial label for sotrovimab with European French and English labelling should be verified because it may not reflect the shelf-life authorized by Health Canada for this product. Current Canadian expiry information should be verified at www.sotrovimabinfo.com. Sotrovimab should not be used beyond the valid Canadian expiry date provided at www.sotrovimabinfo.com.
    • GlaxoSmithKline has developed French and English vial and carton labels that Health Canada has approved (see Appendix B), and has made them available on www.sotrovimabinfo.com for reference by healthcare professionals.
    • Paper copies of the Canadian Product Monograph, including Patient Medication Information, are available upon request from GlaxoSmithKline (1-800-387-7374).

   

Issue

Sotrovimab was authorized for use in relation to the COVID-19 pandemic, in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. To provide earlier access to the product in the context of the global pandemic, GlaxoSmithKline will distribute sotrovimab with European French and English labelling in Canada.

Products affected

Sotrovimab for injection, anti-SARS-CoV-2 spike protein monoclonal antibody, solution for infusion, 500 mg / 8 mL, single-use vial, DIN 02518341.

Background information

Sotrovimab is indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death.

Sotrovimab is NOT authorized for use in patients:

  • who are hospitalized due to COVID-19, OR
  • who require oxygen therapy due to COVID-19, OR
  • who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity).

The safety and efficacy of sotrovimab for injection have not been assessed in pediatric patients (less than 18 years of age). Close monitoring in this patient population is highly recommended.

The use of sotrovimab is permitted under an interim authorization delivered in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization.

Who is affected

Information for healthcare professionals

In order to manage drug supply for COVID-19 patients in the context of the global pandemic, GlaxoSmithKline will distribute sotrovimab in Canada for a limited period of time with European French and English labelling (see Appendix A). Sotrovimab supply with Canadian-specific labelling information is anticipated in 2022.

Healthcare professionals are advised that:

  • The following important Canadian-specific information is absent from the European vial and carton labels:
    • Drug Identification Number (DIN)
    • Prescription product "Pr" symbol
    • Drug product name (sotrovimab for injection)
    • Name and address of the Canadian DIN holder (manufacturer)
    • Name and address of the Canadian importer and distributor
    • The statement that this authorization was issued based on limited clinical testing in humans and/or limited quality information
    • Canadian package insert not enclosed
  • The Canadian Product Monograph, which is available in French and English on Health Canada’s Drug Product Database, www.gsk.ca or www.sotrovimabinfo.com should be used for complete product information.
  • The Canadian-specific labelling information, including the Product Monograph, can be accessed at www.sotrovimabinfo.com and https://covid-vaccine.canada.ca/ or by scanning the QR code found on the outer carton or package leaflet.
  • The expiry date printed on the carton and vial label for sotrovimab with European French and English labelling should be verified because it may not reflect the shelf-life authorized by Health Canada for this product. Current Canadian expiry information should be verified at www.sotrovimabinfo.com.  Sotrovimab should not be used beyond the valid Canadian expiry date provided at www.sotrovimabinfo.com.
  • GlaxoSmithKline has developed French and English vial and carton labels that Health Canada has approved (see Appendix B), and has made them available on www.sotrovimabinfo.com for reference by healthcare professionals.
  • Paper copies of the Canadian Product Monograph, including Patient Medication Information, are available upon request from GlaxoSmithKline (1-800-387-7374).

Action taken by Health Canada

On September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 to expedite the authorization for the importation, sale, and advertising of drugs used in relation to COVID-19 while taking into consideration urgent public health needs. The Interim Order will expire after one year. Sotrovimab was authorized for use by Health Canada under the Interim Order and has been added to the List of authorized drugs, vaccines and expanded indications for COVID-19.

Health Canada has worked with GlaxoSmithKline Inc. to prepare this alert for sotrovimab. 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, as well as through social media channels, including LinkedIn and Twitter.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any serious or unexpected side effects in patients receiving sotrovimab should be reported to GlaxoSmithKline Inc. or Health Canada.

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374

To correct your mailing address or fax number, contact GlaxoSmithKline Inc.

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, contact Health Canada at:

Biologic and Radiopharmaceutical Drugs Directorate
E-mail: hc.brdd.dgo.enquiries.sc@canada.ca

 

Original signed by

Marni Freeman
Country Medical Director, Canada
GlaxoSmithKline Inc.

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