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Kesimpta

Kesimpta Dosage/Direction for Use

ofatumumab

Manufacturer:

Novartis

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Treatment should be initiated by a physician experienced in the management of neurological conditions.
Posology: The recommended dose is 20 mg ofatumumab administered by subcutaneous injection with: initial dosing at weeks 0, 1 and 2, followed by subsequent monthly dosing, starting at week 4.
Missed doses: 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.
Special populations: Adults over 55 years old: 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 Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Patients with renal impairment are not expected to require dose modification (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Patients with hepatic impairment are not expected to require dose modification (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Kesimpta in children aged 0 to 18 years have not yet been established. No data are available.
Method of administration: 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 Precautions).
Comprehensive instructions for administration are provided in the package leaflet.
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