Alemtuzumab

Therapeutic Alemtuzumab antibody from the original Lemtrada® commercial drug.

Reference Standard as Aliquots

Lemtrada®
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2026.08
Lemtrada®
DE
0.5 mg
Max: 10
Min: 1
Step: 1
Unit: aliquot(s)
1.519,00 /aliquot

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Product Information

Here you will find the product information for the reference product.

Lemtrada® / Alemtuzumab Reference Product

Drug nameLemtrada®
INNAlemtuzumab
API typeAlemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
Pharmacotherapeutic group
Selective immunosuppressants
ATC code
L04AA34
Target of antibody
CD52
General functionAlemtuzumab binds to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages. There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells. Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to Tand B lymphocytes.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Alemtuzumab, is a recombinant DNA-derived humanised monoclonal antibody directed against the
21-28 kD cell surface glycoprotein CD52. Alemtuzumab is an IgG1 kappa antibody with human variable
framework and constant regions, and complementary-determining regions from a murine (rat) monoclonal
antibody. The antibody has an approximate molecular weight of 150 kD.

Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Alemtuzumab depletes circulating T and B lymphocytes after each treatment course with the lowest observed
values occurring 1 month after a course of treatment (the earliest post-treatment time point in phase 3
studies). Lymphocytes repopulate over time with B-cell recovery usually completed within 6 months. CD3+
and CD4+ lymphocyte counts rise more slowly towards normal, but generally do not return to baseline by
12-months post-treatment. Approximately 40% of patients had total lymphocyte counts reaching the lower
limit of normal (LLN) by 6 months after each treatment course, and approximately 80% of patients had total
lymphocyte counts reaching the LLN by 12 months after each course.
Original license holder
Sanofi Belgium
Leonardo Da Vincilaan 19
B-1831 Diegem
Belgium
Marketing authorisation numbers
EU/1/13/869/001

Marketing authorisation holder
Sanofi Belgium
Leonardo Da Vincilaan 19
B-1831 Diegem
Belgium
Name of the manufacturer of the biological active substance
Boehringer Ingelheim Pharma GmbH & Co. KG
Birkendorfer Straße 65
88397 Biberach an der Riss
GERMANY
Name and address of the manufacturer(s) responsible for batch releaseGenzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Disodium phosphate dihydrate (E339)
Disodium edetate
Potassium chloride (E508)
Potassium dihydrogen phosphate (E340)
Polysorbate 80 (E433)
Sodium chloride
Water for injections

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