Health Product InfoWatch: April 2025

Contents

• Monthly recap of health product safety information
  • BESREMi (Ropeginterferon alfa-2b-njft) Injection
  • Continuous glucose monitoring smart device software applications
  • Cyclin-dependent kinase inhibitors (abemaciclib, palbociclib and ribociclib) and HMG-CoA reductase inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin) (statins)
  • Unauthorized Health Products
• New health product safety information
  • Notice of market authorization with conditions
    • Enhertu (trastuzumab deruxtecan): Authorization with conditions
    • Zynlonta (loncastuximab tesirine): Authorization with conditions
• Scope
• Reporting Adverse Reactions
• Helpful links
• Contact us

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in March 2025 by Health Canada.

BESREMi (Ropeginterferon alfa-2b-njft) Injection

There is a critical shortage of PEGASYS (peginterferon alfa-2a) injection in Canada. This shortage presents serious risks to patients in Canada who depend on interferon-based therapy for treating myeloproliferative neoplasms. Although PEGASYS is not authorized by Health Canada for this use, it has been prescribed off-label for this condition. Given the critical medical need, Health Canada has permitted the exceptional, temporary importation and sale of a similar but not identical product, US-authorized BESREMi (ropeginterferon alfa-2b-njft) injection with English-only labels by FORUS Therapeutics Inc.

Health Product Risk Communication: BESREMi (Ropeginterferon alfa-2b-njft) Injection

Continuous glucose monitoring smart device software applications

Some people who use continuous glucose monitors have reported not receiving or hearing safety alerts from their smart devices, such as their smartphone or their smartwatch. If a safety alert is missed, patients may fail to treat their hypo- or hyperglycemia, which could cause serious health issues. Users of smart devices should check their alert settings and refer to their device's manual to ensure safety alerts are working as expected. This issue only affects safety alerts from smart devices, such as smartphones; it does not affect other parts of the glucose monitor. Health Canada will continue to work with the manufacturers of diabetes device apps to identify and reduce the risks of safety alerts being unintentionally silenced.

Advisory: Continuous glucose monitoring smart device software applications

Cyclin-dependent kinase inhibitors (abemaciclib, palbociclib and ribociclib) and HMG-CoA reductase inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin) (statins)

This safety review evaluated the risk of rhabdomyolysis due to a drug interaction between cyclin-dependent kinase inhibitors (CDKIs) (abemaciclib-, palbociclib- and ribociclib-containing products) and HMG-CoA reductase inhibitors (statins) (atorvastatin-, fluvastatin-, lovastatin-, pravastatin-, rosuvastatin- and simvastatin-containing products). Health Canada's review found a possible link. Health Canada will work with the manufacturers to update the Canadian product monographs for all CDKIs to include this risk.

Safety Summary Review: Cyclin-dependent kinase inhibitors (abemaciclib, palbociclib and ribociclib) and HMG-CoA reductase inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin) (statins)

Unauthorized Health Products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

Advisory: Unauthorized sexual enhancement products

Advisory: Unauthorized skin lightening and skin treatment products

New health product safety information

The following topics have been selected to raise awareness and encourage reporting of adverse reactions.

Notice of market authorization with conditions

A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the type of authorization granted.

Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.

The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada. For the most up-to-date information, consult Health Canada's NOC database.

Enhertu (trastuzumab deruxtecan): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy, for a new indication for Enhertu^{Footnote *} (trastuzumab deruxtecan), powder for concentrate for solution for intravenous infusion, 100 mg. The new indication for Enhertu, as monotherapy, is for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Patients should be advised of the conditional market authorization for this indication.

For the complete prescribing information and information available for patients/caregivers, please consult the Enhertu Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the AstraZeneca website or by contacting AstraZeneca at 1-800-668-6000. Contact the company for a copy of any references, attachments or enclosures.

Zynlonta (loncastuximab tesirine): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy, for Zynlonta (loncastuximab tesirine), powder for concentrate for solution for intravenous infusion, 10 mg. Zynlonta is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, or high-grade B-cell lymphoma, who have received two or more lines of systemic therapy and have previously received or are unable to receive CAR-T cell therapy. Patients should be advised of the conditional market authorization for this indication.

For the complete prescribing information and information available for patients/caregivers, please consult the Zynlonta Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Sobi website or by contacting Sobi at 1-289-291-3852. Contact the company for a copy of any references, attachments or enclosures.

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada

For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.

Helpful links

• MedEffect^TM Canada
• Recalls and Safety Alerts Database
• New Safety and Effectiveness Reviews
• Canada Vigilance Adverse Reaction Online Database
• Drug Product Database
• Medical Devices Active Licence Listing
• Licensed Natural Health Products Database
• The Drug and Health Product Portal
• Drug Shortages Canada
• Medical Device Shortages
• COVID-19 Vaccines and Treatments Portal

Contact us

Your comments are important to us. Let us know what you think by reaching us at:
infowatch-infovigilance@hc-sc.gc.ca

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9