Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).
Treatment should be initiated by a physician experienced in the management of neurological conditions.
The recommended dose is 20 mg ofatumumab administered by subcutaneous injection with:
If an injection is missed, it should be administered as soon as possible without waiting until the next scheduled dose. Subsequent doses should be administered at the recommended intervals.
No studies have been performed in MS patients over 55 years old. Based on the limited data available, no dose adjustment is considered necessary in patients over 55 years old (see section 5.2).
Patients with renal impairment are not expected to require dose modification (see section 5.2).
Patients with hepatic impairment are not expected to require dose modification (see section 5.2).
The safety and efficacy of Kesimpta in children aged 0 to 18 years have not yet been established. No data are available.
This medicinal product is intended for patient self-administration by subcutaneous injection.
The usual sites for subcutaneous injections are the abdomen, the thigh and the upper outer arm.
The first injection should be performed under the guidance of a healthcare professional (see section 4.4).
Comprehensive instructions for administration are provided in the package leaflet.
Doses up to 700 mg have been administered in clinical studies with MS patients without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted as necessary.
Ofatumumab has been previously used in chronic lymphocytic leukaemia (CLL) indications, at doses up to 2,000 mg administered intravenously via infusion. Ofatumumab administered via subcutaneous injection has not been assessed and is not approved for these indications, and must not be used for the treatment of oncology indications.
2 years.
Kesimpta 20 mg solution for injection in pre-filled syringe:
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Kesimpta 20 mg solution for injection in pre-filled pen:
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light.
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.
Before injection, the pre-filled syringe should be taken out of the refrigerator for about 15 to 30 minutes to allow it to reach room temperature. The pre-filled syringe should be kept in the original carton until ready to use, and the needle cap should not be removed until just before the injection is performed. Prior to use, the solution should be inspected visually by looking through the viewing window. The pre-filled syringe should not be used if the liquid contains visible particles or is cloudy.
Comprehensive instructions for administration are given in the package leaflet.
Before injection, the pre-filled pen should be taken out of the refrigerator for about 15 to 30 minutes to allow it to reach room temperature. The pre-filled pen should be kept in the original carton until ready to use, and the cap should not be removed until just before the injection is performed. Prior to use, the solution should be inspected visually by looking through the viewing window. The pre-filled pen should not be used if the liquid contains visible particles or is cloudy.
Comprehensive instructions for administration are given in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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