Pembrolizumab

Therapeutic Pembrolizumab antibody from the original Keytruda® commercial drug

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PD-1
Monoclonal Antibody
Keytruda®
25 mg/mL
80 µL
2 mg
-80°C
09/2021
794,00 
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Max: 45
Min: 1
Step: 1
PD-1
Monoclonal Antibody
Keytruda®
25 mg/mL
80 µL
2 mg
-80°C
09/2021
794,00 
view product
Max: 50
Min: 1
Step: 1
PD-1
Monoclonal Antibody
Keytruda®
25 mg/mL
80 µL
2 mg
-80°C
09/2021
794,00 
view product
Max: 50
Min: 1
Step: 1
PD-1
Monoclonal Antibody
Keytruda®
25 mg/mL
80 µL
2 mg
-80°C
09/2021
794,00 
view product
Max: 32
Min: 1
Step: 1
PD-1
Monoclonal Antibody
Keytruda®
25 mg/mL
80 µL
2 mg
2-8°C
09/2021
794,00 
view product
Max: 46
Min: 1
Step: 1

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Keytruda® / Pembrolizumab Reference Product

Drug nameKeytruda®
INNPembrolizumab
API typePembrolizumab is a humanized monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilizing sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies
ATC code
L01XC18
Target of antibody
PD-1; Synonyms: CD279, PD1, SLEB2, hPD-1, hPD-l, Ly101, Pdc1
General functionPembrolizumab is a humanized monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. Pembrolizumab potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumors or other cells in the tumor microenvironment.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions.
Original license holder
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Marketing authorisation numbers
EU/1/15/1024/002
Marketing authorisation holder
Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom
Name of the manufacturer of the biological active substance
MedImmune, LL
C Frederick Manufacturing Center (FMC)
633/636/660 Research Court Frederick
MD 21703-8619, USA

Boehringer Ingelheim (BIB)
Pharma GmbH & Co. KG
Birkendorfer Straße 65
88397 Biberach an der Riss
Germany
Name and address of the manufacturer(s) responsible for batch releaseSchering-Plough Labo NV
Industriepark 30, Heist-op-den-Berg
B-2220, Belgium
Max shelf life
24 months
Storage conditions
2°C – 8°C
List of excipients
L-histidine
L-histidine hydrochloride monohydrate
Sucrose
Polysorbate 80
Evidentic Support
+49 (0) 30 959 99 8831

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