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704193005

Refrigerated Storage

BenlystaGSK

GSK
Benlysta
120 mg and 400mg powder for concentrate for solution for infusion

In the event of an inadvertent temperature excursion the following data may be used:

The vials are stable for up to 3 days at 25°C.

When protected from light, the vials are stable up to 21 days at 25°C.

The vials are stable for up to 3 days at –20°C ± 5°C.

The product can be returned to the fridge and no change in expiry dates is required if exposed to the above conditions.

Contact GSK in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details

20 December 2021
London MI Service

BenlystaGlaxoSmithKline UK

GlaxoSmithKline UK
Benlysta
200mg solution for injection in pre-filled syringe or pen

In the event of an inadvertent temperature excursion the following data may be used:
A single Benlysta pre-filled syringe or pen can be stored at temperatures up to a maximum of 25°C for a period of up to 12 hours.
Contact GlaxoSmithKline UK in cases where additional stability data is required. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

No, if exposed to temperatures described above
Yes, if exposed to temperatures described above
21 October 2021
London MI Service

Lactation Safety Information

See summary
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
15 September 2019