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Denosumab

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Topics: CancersCCG commissioned new medicinesDenosumab · MedicineMusculo-skeletal disordersNew MedicinesNHS England commissioned new medicinesPatent expiriesSafety in BreastfeedingStability outside the fridge ·
Contents
  1. dm+d
  2. Articles
  3. Refrigerated Storage
    1. Prolia · Amgen Ltd
    2. XGEVA · Amgen Ltd
  4. Lactation Safety Information
  5. New Medicines
    1. denosumab biosimilar (GP2411) · Osteoporosis
    2. denosumab biosimilar (SB16) · Osteoporosis

dm+d

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Articles

Safety in Lactation: Drugs affecting bone metabolism

18 September 2020Drugs used exclusively for postmenopausal osteoporosis have not been included. Bisphosphonates have very poor oral bioavailability in fasting adults, which is decreased even further in…
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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:
Prolia vials remain stable when exposed to a temporary room temperature exposure up to 30°C. The cumulative room temperature exposure time must not exceed 30 days and exposure should be limited to one to two excursions. In the event of a temporary room temperature exposure, Prolia may be returned to the recommended condition of 2-8°C until the product expiry.

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.

No
Yes
29 May 2019
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:
Xgeva vials remain stable when exposed to a temporary room temperature of up to 30°C. The cumulative room temperature exposure time must not exceed 30 days and exposure should be limited to one to two excursions.

In the event of a temporary room temperature exposure, Xgeva may be returned to the recommended condition of 2-8°C until the product expiry.

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.

No
Yes
15 March 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

New Medicines

denosumab biosimilar (GP2411)Osteoporosis

Information

denosumab biosimilar (GP2411)
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Antibody that inhibits RANKL protein, an activator of osteoclasts
In England and Wales more than 2 million women have osteoporosis and there are around 180,000 fractures per year due to osteoporosis [2].
Osteoporosis
Subcutaneous

Trial or other data

Evidence based evaluations

MTRAC

denosumab biosimilar (SB16)Osteoporosis

Information

denosumab biosimilar (SB16)
Biosimilar
Samsung Bioepis
Samsung Bioepis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Human monoclonal antibody that inhibits RANKL protein, an activator of osteoclasts
1 in 3 women and 1 in 5 men will have an osteoporotic fracture in their lifetime. Yhere are around 180,000 fractures per year due to osteoporosis in England and Wales [2]
Osteoporosis
Subcutaneous

Evidence based evaluations

MTRAC