# Major Recall Alert: Shortage of PEGASYS (Peginterferon Alfa-2a) Injection in Canada
Health Canada has announced a **critical shortage of PEGASYS (peginterferon alfa-2a)** injection due to manufacturing disruptions, posing serious risks to patients in Canada who rely on interferon-based therapies for treating **myeloproliferative neoplasms (MPNs)**. Although PEGASYS is not authorized by Health Canada for MPNs, it is frequently prescribed off-label for this condition, creating an urgent medical need. To address this shortage, Health Canada has temporarily approved the importation of **US-authorized BESREMi (ropeginterferon alfa-2b-njft)** injections, available with English-only labels through FORUS Therapeutics Inc.
If you or your patients are affected by this shortage, read on to understand your options, guidelines for using BESREMi, and how to stay informed.
## Why This Recall is Important
This shortage directly impacts patients who require PEGASYS for off-label treatment of **MPNs**, a group of severe blood cancers. **PEGASYS injection** is primarily authorized in Canada for managing chronic hepatitis B and C but is also used off-label for MPNs, including certain types like polycythemia vera (PV).
With no immediate resolution to the manufacturing disruption, Health Canada has acted swiftly by allowing the importation of BESREMi—a related but distinct product approved in the United States by the FDA for treating **polycythemia vera (PV)**, a subtype of MPNs. However, it is critical to note:
- **BESREMi is not a direct substitute for PEGASYS.**
- It has different active ingredients, dosing instructions, safety considerations, and monitoring requirements.
### Key Risks
- **Patients and healthcare providers need to adapt to a new product** with unfamiliar labeling and usage instructions.
- BESREMi does not have Health Canada’s approval for safety or quality assessment, requiring caution while prescribing or administering.
This situation highlights the importance of proactive communication and patient education to ensure safe and effective use of alternative treatments.
## Details of the Recall
The shortage and temporary importation involve the following:
- **Product Affected**: PEGASYS (peginterferon alfa-2a) injection.
- **Reason for Shortage**: Manufacturing disruptions.
- **Temporary Alternative**: US-authorized BESREMi (ropeginterferon alfa-2b-njft) injection.
- **Supplier of BESREMi in Canada**: FORUS Therapeutics Inc.
### Important Differences Between PEGASYS and BESREMi
- **Active Ingredients**: PEGASYS contains peginterferon alfa-2a; BESREMi contains ropeginterferon alfa-2b-njft.
- **Indications**: While PEGASYS is an off-label option for MPNs, BESREMi is FDA-approved for polycythemia vera (PV) in the US.
- **Administration & Monitoring**: BESREMi has distinct dosing instructions and requires careful monitoring.
Healthcare professionals should refer to the **US Prescribing Information (USPI)** for exact dosing guidelines and safety precautions for BESREMi.
## What You Should Do
### For Healthcare Professionals:
- **Consult the USPI**: The prescribing information for BESREMi, along with a **Medication Guide and Instructions for Use**, is available in English and French.
- **Educate Patients**: Inform patients about the benefits and risks associated with BESREMi, emphasizing its off-label status in Canada. Educate them on proper usage and the importance of monitoring.
**Important Notes**:
- BESREMi does not have a Drug Identification Number (DIN) or scannable barcode for Canadian pharmacy systems.
- Pharmacies and healthcare institutions must implement workarounds for tracking and processing orders.
### For Patients and Caregivers:
- **Talk to Your Doctor**: If you are affected by the PEGASYS shortage, discuss BESREMi as a potential alternative.
- **Monitor Side Effects**: Report any serious or unexpected side effects to your healthcare provider immediately.
- **Follow Instructions**: BESREMi is supplied in pre-filled syringes, but proper dosing may require discarding excess medicine. Follow all instructions carefully.
To report side effects or safety concerns, contact FORUS Therapeutics Inc. using the following:
- Phone: 1-877-359-9595
- Email: **forus-pv@innomar-strategies.com**
Alternatively, report adverse reactions to Health Canada via their [Adverse Reaction Reporting page](http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php).
## Stay Safe – Get Instant Recall Alerts
In times of medical shortages, staying informed is critical. Subscribe to Health Canada’s **MedEffect™ e-Notice system** for updates on recalls, shortages, and safety alerts.
For further details regarding this specific situation, visit the official Health Canada announcement [here](https://recalls-rappels.canada.ca/en/alert-recall/importation-us-authorized-besremi-ropeginterferon-alfa-2b-njft-injection-due-current).
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