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Refrigerated Storage

EnbrelPfizer

Pfizer
Enbrel
Powder and solvent for solution for injection, solution for injection in pre-filled pen or syringe

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

Enbrel is licensed for storage at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.

For 25mg and 50mg Enbrel pre-filled syringe and pen, in-house stability data shows:

  • the product is stable for 7 days when exposed to 40°C
  • the product is stable for 1 month when exposed to 25°C
  • the product is stable for 30 months when exposed to 3 temperature cycles of -20°C for 3 days followed by 3 days at 30°C then storage at 5°C. During the last month of study, the product was stored at 25°C.

For 10mg and 25mg Enbrel powder and solvent for solution for injection, in-house stability data shows:

  • the product is stable for 12 months when exposed to 25°C
  • the product is stable for 6 months when exposed to storage at 40°C
  • the product is stable for 48 months when exposed to 3 temperature cycles of -20°C for 4 days followed by 4 days at 30°C then storage at 5°C. During the last month of study, the product was stored at 25°C.
2 March 2022
London MI Service

BenepaliBiogen

Biogen
Benepali
25 mg & 50mg solution for injection in pre-filled syringe; 50 mg solution for injection in pre-filled pen.

In the event of an inadvertent temperature excursion the following data may be used:
Benepali may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Benepali should be discarded if not used within four weeks of removal from refrigeration.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

4 weeks
No
19 March 2021
London MI service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
See summary
Limited 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
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16 September 2019

For psoriasis

For psoriasis
Topical psoriasis preparation / corticosteroid if appropriate
Limited 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
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16 September 2019