Authorization of Casirivimab and Imdevimab with English-only Labels for Use in Relation to the COVID-19 Pandemic

Starting date:
July 30, 2021
Posting date:
July 30, 2021
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs, Biologic/vaccine
Source of recall:
Health Canada
Issue:
Important Safety Information, Product Safety, Supply
Audience:
Healthcare Professionals
Identification number:
RA-76129

Last updated:

Audiences

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

Key messages

  • On June 9, 2021, casirivimab and imdevimab, two monoclonal antibodies, were authorized for use in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
  • Casirivimab and imdevimab, to be administered together, are 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, Hoffmann-La Roche is providing one standard global pandemic packaging with English-only labelling in order to expedite the global distribution of casirivimab and imdevimab. Casirivimab and imdevimab supply with Canadian-specific labelling information will be implemented by March 31, 2022 (for newly ordered inventory).
  • Healthcare professionals are advised that:
    • Important Canadian-specific information is absent from the global 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, at www.cas-imd.ca or www.rochecanada.com, should be used for complete product information.
    • The Canadian-specific labelling information, including the Product Monograph, can be accessed at www.cas-imd.ca or by scanning the QR code sticker found on the outer carton of the global packaging. 

   

Issue

Casirivimab and imdevimab (administered together) were 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, Hoffmann-La Roche will distribute one standard global pandemic packaging with English-only labelling.

Products affected

Casirivimab and imdevimab concentrate for solution for infusion are available in cartons that contain either two single-use 6mL vials or two single-use 20mL vials per package.

Each carton contains 2 single-use vials per package:

  • DIN 02516705 (20 mL vial size)
    • 1 vial of 1332 mg casirivimab / 11.1 mL (120 mg/mL) and
    • 1 vial of 1332 mg imdevimab / 11.1 mL (120 mg/mL)

OR

  • DIN 02516691 (6 mL vial size)
    • 1 vial of  300 mg casirivimab / 2.5 mL (120 mg/mL) and
    • 1 vial of 300 mg imdevimab / 2.5 mL (120 mg/mL)

Background information

Casirivimab and imdevimab, to be administered together, are 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.

Casirivimab and imdevimab are 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.

Health Canada has authorized the sale of this COVID-19 drug based on limited clinical testing in humans and limited quality information. Clinical study for the authorization of casirivimab and imdevimab included subjects aged 18 years and older. Close monitoring is highly recommended for adolescents 12-17 years of age who may receive this therapy.

The use of casirivimab and imdevimab are 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 provide rapid access to casirivimab and imdevimab for COVID-19 patients, Hoffmann-La Roche will distribute product labelled in English only (see Appendix A, see images below) for a limited period of time. Casirivimab and imdevimab supply with Canadian-specific information will be implemented by March 31, 2022 (for newly ordered inventory).

Healthcare professionals are advised that:

  • The Canadian Product Monograph, which is available in French and English on Health Canada’s Drug Product Database, at www.cas-imd.ca or www.rochecanada.com should be used for complete product information.
  • The following important Canadian-specific information is absent from the global vial and carton labels:
    • Drug Identification Number (DIN)
    • Prescription product "Pr” symbol
    • Name and address of the Canadian DIN holder
    • Name and address of the Canadian importer and distributor
    • All corresponding text in French
    • The statement that this authorization was issued based on limited clinical testing in humans and/or limited quality information.
  • The Canadian-specific labelling information, including the Product Monograph, can be accessed at www.cas-imd.ca or by scanning the QR code sticker found on the outer carton of the global packaging.
  • Hoffmann-La Roche has developed French and English vial and carton labels that Health Canada has approved (see Appendix B, see images below), and has made them available on www.cas-imd.ca for reference by healthcare professionals.
  • For any questions, or if you would like to request a paper copy of the Product Monograph, contact Hoffmann-La Roche Limited directly at 1-888-762-4388.

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. Casirivimab and imdevimab were authorized for use by Health Canada under the Interim Order and have been added to the List of authorized drugs and expanded indications for COVID-19.

Health Canada has worked with Hoffmann-La Roche Limited to prepare this alert for casirivimab and imdevimab. 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 case side effects in patients receiving casirivimab and imdevimab should be reported to Hoffmann-La Roche Limited, or to 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, contact Health Canada at:

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

Original signed by

 

Loredana Regep, MD
Vice President, Medical & Regulatory Affairs
Hoffmann-La Roche Limited

Images

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