Evrysdi® (risdiplam) 0.75 mg/mL Powder for Oral Solution: Potential presence of insoluble foreign particles in the reconstituted solution

A Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals on the potential presence of insoluble foreign particles in reconstituted Evrysdi^® 0.75 mg/mL Powder for Oral Solution, following overseas complaints. Three potentially affected batches were imported into Singapore: B2033B16, B2034B17 and B2039B15. Investigations by the manufacturer found that these particles consist mainly of white Polytetrafluorethylene (PTFE-Teflon) which is a chemically inert, non-toxic material expected to pass through the gastrointestinal tract unchanged without systemic absorption. Based on Roche’s assessment, the presence of these small particles does not pose a specific or heightened risk to patients with spinal muscular atrophy and the clinical risk is considered low. Healthcare professionals are advised to conduct visual checks of the reconstituted solution prior to dispensing the product. They are also advised to remind patients and caregivers to follow the ‘Instructions for Use – Administration’ per the package insert to detect bubbles or foreign particles prior to administration. The product should be replaced if any foreign floating particles are detected. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.