Takeda (now part of Shire) has conducted internal stability studies to evaluate the impact of temperature excursions on agalsidase alfa vials (Shire Internal Data). Results indicate there is no impact on the product stability or original shelf life of agalsidase alfa during a single temperature excursion of:
-20˚C to <2˚C for up to 15 days
>8˚C to ≤27˚C for up to 45 days
This is subject to the product being stored at the licensed storage conditions for the remaining period of time. These studies suggested that the quality attributes of the product would be expected to be maintained until expiration date.
Please note, stability data at Shire is continually monitored and subject to change. Please contact Shire on a case by case basis for any temperature excursions.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact Shire in all cases where deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.