Importation of US-labelled Dexrazoxane for Injection distributed by Mylan Pharmaceuticals ULC due to shortage of Canadian-labelled Dexrazoxane

Starting date:
December 1, 2020
Posting date:
December 1, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information, Product Safety, Supply
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-74479

Last updated:

Audience

Healthcare professionals including oncologists, pharmacists and nurses working in cancer centres and oncology clinics.

Key messages

  • Due to a shortage of ZINECARD (Dexrazoxane for Injection) in Canada and given the medical necessity of this product, Health Canada has expressed no objection to the temporary importation and distribution of US-labelled Dexrazoxane for Injection. Dexrazoxane for Injection is used to reduce (prevent) the incidence and severity of cardiotoxicity caused by doxorubicin administration in patients with metastatic breast cancer.
  • The US-labelled Dexrazoxane for Injection has the same active ingredient, strength (250 mg/vial), and concentration after reconstitution (10 mg/mL) as the Canadian-labelled product. However, there are key differences in the preparation instructions.
  • Healthcare professionals are advised that:
    • The US-labelled Dexrazoxane for Injection requires different diluents for reconstitution and further dilution in comparison with the Canadian product.
    • Sodium Lactate Injection USP is to be used for reconstitution of the US-labelled Dexrazoxane for Injection, which is provided in the packaging (see Appendix A).
    • Either 0.9% Sodium Chloride Injection, or 5% Dextrose Injection are to be used for dilution prior to infusion after reconstitution of the US-labelled Dexrazoxane for Injection.
    • For reconstitution and dilution instructions, the US-labelled product information should be consulted and can be accessed at: https://www.viatris.com/en-us/lm/countryhome/us-products/productcatalog/productdetails?id=e7273cd8-7a2f-4188-8afd-7f60aa865e6a.
    • The Canadian product monograph for Dexrazoxane for Injection, available in English and French on Health Canada’s Drug Product Database, should be used for information on  indications, contraindications, warnings and precautions and administration.

   

Issue

Due to a shortage in Canada, Pfizer Canada ULC has informed Health Canada that a steady supply of its ZINECARD (Dexrazoxane for Injection) is not expected until January 31, 2021. Given the medical necessity of this product, Health Canada has expressed no objection to the temporary importation and distribution of US-labelled Dexrazoxane for Injection.

Products affected

Product Name   Dosage Form, Strength, and Route of Administration Country of Origin and Identifying Code Manufacturer Importer and Supplier in Canada
Dexrazoxane for Injection 250 mg and 0.167M (M/6) Sodium Lactate Injection, USP Powder for solution,
250 mg,
Intravenous use

USA

NDC 67457-207-25

Mylan Institutional LLC (USA) Mylan Pharmaceuticals ULC

Mylan Pharmaceuticals ULC does not currently market Dexrazoxane for Injection in Canada.

Background information

In Canada, Dexrazoxane for Injection is indicated for reducing (preventing) the incidence and severity of cardiotoxicity associated with doxorubicin administration for the treatment of metastatic breast cancer in patients who have already experienced a partial response or at least maintained stable disease.

Dexrazoxane is marketed under the brand name ZINECARD by Pfizer Canada ULC, the sole Canadian license holder. Pfizer has informed Health Canada of a disruption in the manufacturing of dexrazoxane which has caused an expected shortage of supply until January 31, 2021. Pfizer has stated that the product is currently on strict allocation and that there is no alternative on the Canadian market. Additional information and the latest updates regarding the shortage of Dexrazoxane for Injection are available at: drugshortagescanada.ca.

The temporary importation of US-labelled Dexrazoxane for Injection distributed by Mylan Pharmaceuticals ULC will maximize the amount of this product available to patients in Canada and help mitigate the current market shortage.

Who is affected

Information for healthcare professionals

The US-labelled Dexrazoxane for Injection has the same active ingredient, strength (250 mg/vial), and concentration after reconstitution (10 mg/mL) as the Canadian-labelled product. However, there are key differences in the preparation instructions.

Healthcare professionals are advised that:

  • The US-labelled Dexrazoxane for Injection requires different diluents for reconstitution and further dilution in comparison with the Canadian product.
  • Sodium Lactate Injection USP is to be used for reconstitution of the US-labelled Dexrazoxane for Injection, which is provided in the packaging (see Appendix A).
  • Either 0.9% Sodium Chloride Injection, or 5% Dextrose Injection are to be used for dilution prior to infusion after reconstitution of the US-labelled Dexrazoxane for Injection.
  • For reconstitution and dilution instructions, the US-labelled product information should be consulted and can be accessed at: https://www.viatris.com/en-us/lm/countryhome/us-products/productcatalog/productdetails?id=e7273cd8-7a2f-4188-8afd-7f60aa865e6a
  • The Canadian product monograph for Dexrazoxane for Injection, available in English and French on Health Canada’s Drug Product Database, should be used for information on indications, contraindications, warnings and precautions and administration.
Table 1. Comparison of Reconstitution and Dilution for the Canadian vs US-labelled Dexrazoxane for Injection
Product name, strength Recommended diluent and volume to be added for reconstitution Concentration after reconstitution Recommended solution for dilution of reconstituted product Concentration range for infusion
Canadian–labelled Dexrazoxane
for Injection (ZINECARD),
250 mg/vial
Sterile Water for Injection, USP, 25 mL

10 mg/mL

Lactated Ringer’s Injection, USP 1.3 to 3 mg/mL
US-labelled Dexrazoxane
for Injection,
250 mg/vial
0.167 Molar (M/6)
Sodium Lactate Injection, USP,
25 mL
(provided in the packaging)
10 mg/mL 0.9% Sodium Chloride Injection, USP or
5% Dextrose Injection, USP
1.3 to 5 mg/mL

Institutions should be aware that no Canadian barcode or Drug Identification Number (DIN) is included on the US-labelled Dexrazoxane for Injection product. An institution-generated sticker or overlabel may be required to enable barcode scanning and allow proper identification of the product being dispensed and administered.

Information about US-labelled Dexrazoxane for Injection and the foreign package insert for healthcare professionals are available on the Mylan Pharmaceuticals ULC website:
https://www.viatris.com/en-us/lm/countryhome/us-products/productcatalog/productdetails?id=e7273cd8-7a2f-4188-8afd-7f60aa865e6a

Action taken by Health Canada

Given the medical necessity of Dexrazoxane for Injection in Canada and to mitigate the shortage of this product, Health Canada has expressed no objection to the temporary importion and distribution of US-labelled Dexrazoxane for Injection.

Health Canada has worked with Mylan Pharmaceuticals ULC to prepare this alert for Dexrazoxane for Injection. 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 as well as 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 of serious or unexpected side effects in patients receiving Dexrazoxane for Injection should be reported to Mylan Pharmaceuticals ULC or Health Canada.

Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON M8Z 2S6
1-800-575-1379

To correct your mailing address or fax number, contact Mylan Pharmaceuticals ULC.

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:

Regulatory Operations and Enforcement Branch
E-mail: hc.hpce-cpsal.sc@canada.ca

 

Original signed by

Anca Schmidt
Head of North America Affiliates Quality
Viatris

Images

Select thumbnail to enlarge - opens in a new window