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Refrigerated Storage
BenlystaGSK
In the event of an inadvertent temperature excursion the following data may be used:
Results from stability testing suggest that vials of belimumab are stable for up to 3 days at 25°C, 60% relative humidity (RH) and exposed to ambient room lighting conditions.
Stability studies have shown that the vials are stable for up to 21 days at a temperature of 25°C, 60% relative humidity when protected from light.
Stability if exposed to temperature cycling:
Unreconstituted vials of IV belimumab are stable when returned to refrigeration (2°C and 8°C) one time after warming to 25°C (60% RH).
Stability has also been evaluated upon multiple cycles (5 cycles with 48 hours at each cycling temperature) between refrigeration temperatures (2°C to 8°C) and 40°C (75% RH) conditions. The ‘cycling’ process does not impact product quality. However, it should be noted that degradation is accelerated with increasing temperature and exposure time (e.g. extended exposure to 40°C).
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact GSK in cases where the product has been exposed to temperature deviation other than described above. Refer to the current BNF for company contact details.
Do not freeze.
Store in the original carton in order to protect from light.
BenlystaGSK
In the event of an inadvertent temperature excursion the following data may be used:
Supplemental stability studies suggest that prior to dispensing belimumab subcutaneous to the patient, temperature excursions between 9°C to 25°C for a cumulative time of up to 24 hours are allowed (while the product is protected from light).
The results also suggest that the product is stable for use if the product is exposed to a further 12 hours up to 30°C by the patient.
The additional allotted time of up to 12 hours at room temperature (up to 30°C) is permitted when belimumab pre-filled syringes or pens are protected from direct window filtered sunlight by storing in the original carton or when the product is removed from the box containing the syringes or pens and exposed to indoor artificial light at room temperature (up to 30°C).
Stability if exposed to temperature cycling in pharmacies or other storage locations:
The product was cycled 3 times between 5°C and –20°C, 5°C and –5°C, 5°C and 15°C, and 5°C and 30°C with protection from light (a total of 6 days at each cycling temperature). Post temperature cycling, the samples were stored for up to 33 months at recommended refrigeration (between 2°C and 8°C) and for 6 months at accelerated condition (25°C). The results suggested that potency of the product remained intact but characteristics such as aggregation and deamidation were increased by some of the thermal cycling conditions.
Stability if cycled between temperatures during patient use:
In cases where the product undergoes temperature cycling between refrigerated conditions (2°C to 8°C) and room temperature (up to 30°C), the 12 hour limit refers to the total cumulative exposure time outside of refrigeration. Up to 3 cycles between refrigeration and room temperature are considered acceptable.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact GSK in cases where the product has been exposed to temperature deviation other than described above. Refer to the current BNF for company contact details.