Denosumab

Therapeutic Denosumab antibody from the original Prolia® commercial drug

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RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
-80°C
11/2018
462,00 
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Max: 7
Min: 1
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RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
-80°C
07/2019
462,00 
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Max: 10
Min: 1
Step: 1
RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
-80°C
10/2019
462,00 
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Max: 7
Min: 1
Step: 1
RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
-80°C
04/2020
462,00 
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Max: 9
Min: 1
Step: 1
RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
-80°C
09/2020
462,00 
view product
Max: 7
Min: 1
Step: 1
RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
-80°C
01/2021
547,00 
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Max: 4
Min: 1
Step: 1
RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
2-8°C / -80°C
06/2022
598,00 
view product
Max: 20
Min: 3
Step: 1
RANKL
Monoclonal Antibody
Prolia®
60 mg/mL
50 µL
3 mg
2-8°C / -80°C
10/2022
598,00 
view product
Max: 20
Min: 3
Step: 1

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Prolia® / Denosumab Reference Product

Drug nameProlia®
INNDenosumab
API typeDenosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Pharmacotherapeutic group
Drugs for the treatment of bone diseases – Other drugs affecting bone structure and mineralization
ATC code
M05BX04
Target of antibody
RANKL; Synonyms: CD254, ODF, OPGL, OPTB2, TRANCE, hRANKL2, sOdf, TNFSF11, Ly109l, OPG, Trance, cd254, odf, opgl, optb2, rankl, sodf, tnfsf11, trance
General functionDenosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Denosumab treatment rapidly reduced the rate of bone turnover, reaching a nadir for the bone resorption marker serum type 1 C-telopeptides (CTX) (85% reduction) by 3 days, with reductions maintained over the dosing interval. At the end of each dosing interval, CTX reductions were partially attenuated from maximal reduction of ≥ 87% to approximately ≥ 45% (range 45-80%), reflecting the reversibility of Prolia’s effects on bone remodelling once serum levels diminish. These effects were sustained with continued treatment. Bone turnover markers generally reached pre-treatment levels within 9 months after the last dose. Upon re-initiation, reductions in CTX by denosumab were similar to those observed in patients initiating primary denosumab treatment.
Original license holder
Amgen
Marketing authorisation numbers
EU/1/10/618/001
EU/1/10/618/002
EU/1/10/618/003
Marketing authorisation holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Name of the manufacturer of the biological active substance
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands


Amgen Technology Ireland (ADL)
Pottery Road
Dun Laoghaire
Co Dublin
Ireland
Name and address of the manufacturer(s) responsible for batch releaseAmgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
Acetic acid, glacial*
Sodium hydroxide (for pH adjustment)*
Sorbitol (E420)
Polysorbate 20
Evidentic Support
+49 (0) 30 959 99 8831

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