On January 28, 2026, Swissmedic released a statement regarding Ocrevus (ocrelizumab), a medication used to treat multiple sclerosis. The update focuses on the risk of liver damage associated with the drug.
Swissmedic is the regulatory authority for therapeutic products in Switzerland, and their communication affects healthcare professionals and the pharmaceutical industry.
Navigation: What is Ocrevus? | What changed? | Who is affected? | What should healthcare professionals do? | FAQ | Conclusion | Disclaimer
What is Ocrevus?
Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to target and deplete CD20-positive B cells. It is used to treat adult patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
What changed?
Swissmedic has updated the prescribing information for Ocrevus to include a warning about the risk of liver damage. This change is based on post-marketing reports and studies that have shown a potential association between ocrelizumab and liver injury.
Liver Damage
The liver damage reported in association with Ocrevus includes elevated liver enzymes, hepatitis, and liver failure. In some cases, these events have been severe and required hospitalization.
Who is affected?
Patients taking Ocrevus are at risk of developing liver damage. Healthcare professionals should be aware of this risk and monitor their patients accordingly.
What should healthcare professionals do?
Healthcare professionals should carefully evaluate the benefits and risks of Ocrevus before prescribing it to their patients. They should also monitor their patients for signs of liver damage and adjust treatment as needed.
FAQ
- Q: What is the risk of liver damage associated with Ocrevus?
A: The risk of liver damage associated with Ocrevus is unknown, but post-marketing reports and studies have shown a potential association between ocrelizumab and liver injury. - Q: How can I minimize the risk of liver damage in my patients taking Ocrevus?
A: Healthcare professionals can minimize the risk of liver damage by carefully evaluating the benefits and risks of Ocrevus before prescribing it, monitoring their patients for signs of liver damage, and adjusting treatment as needed.
Conclusion
In conclusion, Swissmedic has updated the prescribing information for Ocrevus to include a warning about the risk of liver damage. Healthcare professionals should be aware of this risk and take steps to minimize it in their patients.
Disclaimer
This information is not intended to be a substitute for professional medical advice. Healthcare professionals should always consult the official prescribing information and relevant guidelines before making treatment decisions.
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/health-professional-communication–hpc-/dhpc-ocrevus-ocrelizumab.html