Evrysdi (risdiplam): Omission in EU Product Labeling Identified

On the 21^st of May Roche has identified a mistake in Evrysdi product labelling statement & SmPC as they found out it was missing out the point related to storage condition.

The mandatory storage statement “Do not store above 25°C” is missing from section 6.4 of the SmPC, as well as from the product carton, bottle labels, and Instruction for Constitution of Evrysdi 0.75 mg/mL powder for oral solution. The package leaflet remains unaffected, since patients only receive the constituted oral solution, for which the correct storage conditions are already included. 

Pharmacists are advised to:

Not dispense Evrysdi 0.75 mg/mL Powder for Oral Solution if:

• Exposed to >40°C / 75% RH for 3 months, or
• Exposed to >30°C / 75% RH for 12 months.

Action required:

• Follow the local country process to submit a product complaint (available 24/7).
• Obtain guidance on product replacement to ensure uninterrupted patient dosing.

Healthcare professionals are asked to report any suspected adverse drug reactions in accordance with the national spontaneous reporting system and include batch/Lot number if available.

Learn more: The newly published DHPC: Evrysdi – direct healthcare professional communication (DHPC) | European Medicines Agency (EMA)