A mandatory labelling statement has been mistakenly omitted from the EU product label and summary of product characteristics (SmPC) for Evrysdi 0.75 mg/ml powder for oral solution.

The statement “Do not store above 25°C” is missing from section “6.4 Special precautions for storage” (within the powder for oral solution sub-section) of the SmPC, product carton and bottle labels, and the Instruction for Constitution. The package leaflet is not impacted, as the patients only receive the constituted oral solution, and the proper storage condition for the constituted oral solution is already included in the package leaflet.

Pharmacists must not dispense Evrysdi 0.75 mg/mL powder for oral solution if the storage temperature of the unconstituted powder has exceeded  40°C / 75% RH (relative humidity) for 3 months, or 30°C / 75% RH for 12 months because the impact of storing outside of these conditions has not been studied.

Background
Evrysdi (risdiplam) is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. Evrysdi powder for oral solution must be constituted with purified water or water for injection by a healthcare professional (e.g. pharmacist) prior to being dispensed.