KESIMPTA Solution for injection Ref.[27863] Active ingredients: Ofatumumab

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

Product name and form

Kesimpta 20 mg solution for injection in pre-filled syringe.

Kesimpta 20 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Solution for injection (injection) in pre-filled pen (Sensoready Pen).

The solution is clear to slightly opalescent, and colourless to slightly brownish-yellow.

Qualitative and quantitative composition

Kesimpta 20 mg solution for injection in pre-filled syringe:

Each pre-filled syringe contains 20 mg ofatumumab in 0.4 ml solution (50 mg/ml).

Kesimpta 20 mg solution for injection in pre-filled pen:

Each pre-filled pen contains 20 mg ofatumumab in 0.4 ml solution (50 mg/ml).

Ofatumumab is a fully human monoclonal antibody produced in a murine cell line (NS0) by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ofatumumab

Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells.

List of Excipients

L-arginine
Sodium acetate trihydrate
Sodium chloride
Polysorbate 80
Disodium edetate dihydrate
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

Kesimpta 20 mg solution for injection in pre-filled syringe:

Kesimpta is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield. The syringe is assembled with a plunger rod and a needle safety device.

Kesimpta is available in unit packs containing 1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.

Not all pack sizes may be marketed.

Kesimpta 20 mg solution for injection in pre-filled pen:

Kesimpta is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield. The syringe is assembled into an auto-injector.

Kesimpta is available in unit packs containing 1 pre-filled pen and in multipacks containing 3 (3 packs of 1) pre-filled pens.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/21/1532/001-004

26 March 2021

Drugs

Drug Countries
KESIMPTA Brazil, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States

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