LEMTRADA Concentrate for solution for infusion (2020)
Active ingredients: Alemtuzumab
Product Name and Form
LEMTRADA 12 mg concentrate for solution for infusion.
Concentrate for solution for infusion (sterile concentrate).
A clear, colourless to slightly yellow concentrate with pH 7.0–7.4.
Qualitative and Quantitative Composition
Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
Excipients with known effect:
This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassium-free’.
This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes. Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding 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.
Disodium phosphate dihydrate (E339)
Potassium chloride (E508)
Potassium dihydrogen phosphate (E340)
Polysorbate 80 (E433)
Water for injections
Pack sizes and Marketing
LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Pack size: carton with 1 vial
Sanofi Belgium, Leonardo Da Vincilaan 19, B-1831, Diegem, Belgium
Date of first authorisation: 12 September 2013
Date of latest renewal: 2 July 2018