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Denosumab

Published
Topics: CancersDenosumabMusculo-skeletal disorders · Patent expiriesSafety in BreastfeedingStability outside the fridge ·
Contents
  1. dm+d
  2. Refrigerated Storage
    1. Prolia · Amgen Ltd
    2. XGEVA · Amgen Ltd
  3. Lactation Safety Information

dm+d

446457007

Refrigerated Storage

ProliaAmgen Ltd

Amgen Ltd
Prolia
60 mg solution for injection in a pre-filled syringe

In the event of an inadvertent temperature excursion the following data may be used:
Once removed from the refrigerator, Prolia may be stored at room temperature (up to 25°C) for up to 30 days in the original container. It must be used within this 30 days period.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact Amgen Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.

Reduce expiry to 30 days if exposed to temperature excursions as described above
No, store Prolia outside of the fridge if exposed to the temperature excursion above
1 October 2021
London MI Service

XGEVAAmgen Ltd

Amgen Ltd
XGEVA
120 mg solution for injection

In the event of an inadvertent temperature excursion the following data may be used:
Once removed from the refrigerator, XGEVA vials may be stored at room temperature (up to 25°C) for up to 30 days in the original container. It must be used within this 30 days period.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact Amgen Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.

Reduce expiry to 30 days if exposed to temperature excursions as described above
No, store XGEVA outside of the fridge if exposed to the temperature excursion above
1 October 2021
London MI Service

Lactation Safety Information

Caution
Bisphosphonate
No published evidence of safety
Due to the drug’s properties, low levels anticipated in milk which are likely to be degraded in infant’s GI tract
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
Safety in Lactation: Drugs affecting bone metabolism
17 September 2020
LactMed