Kesimpta

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.

2). 2). 2). 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. 4). Comprehensive instructions for administration are provided in the package leaflet.

4 and below subsection “Description of selected adverse reactions” for further details). Tabulated list of adverse reactions Adverse reactions that have been reported in association with the use of ofatumumab in pivotal RMS clinical studies and from post-marketing experience are listed by MedDRA system organ class in Table 1.

Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from the available data).

Table 1 Tabulated list of adverse reactions Infections and infestations Very common Upper respiratory tract infections1 Urinary tract infections2 Common Oral herpes Immune system disorders Not known Hypersensitivity reactions3 Gastrointestinal disorders Common Nausea, vomiting4 General disorders and administration site conditions Very common Injection-site reactions (local) Investigations Common Blood immunoglobulin M decreased Injury, poisoning and procedural complications Very common Injection-related reactions (systemic) 1 Grouping of preferred terms (PTs) was considered for ADR frequency determination and includes the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis.

2 Grouping of preferred terms (PTs) was considered for ADR frequency determination and includes the following: urinary tract infection, cystitis, escherichia urinary tract infection, asymptomatic bacteriuria, bacteriuria. 4). 8%, respectively).

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). 8%) mild to moderate in severity. 8). g. tongue, pharyngeal or laryngeal swelling), and rare cases which were reported as anaphylaxis.

While there were some cases which were serious and resulted in discontinuation of ofatumumab treatment, there were also serious cases where patients were able to continue ofatumumab treatment without further incidents. Some SIRR symptoms may be clinically indistinguishable from Type 1 acute hypersensitivity reactions (IgE-mediated).

A hypersensitivity reaction may present during any injection, although typically would not present with the first injection. For subsequent injections, more severe symptoms than previously experienced, or new severe symptoms, should prompt consideration of a potential hypersensitivity reaction.

3). 4 Only limited benefit of premedication with steroids was seen in RMS clinical studies. Injection-related reactions can be managed with symptomatic treatment, should they occur. Therefore, use of premedication is not required. 2). 8).

Infections It is recommended to evaluate the patient’s immune status prior to initiating therapy. 8). Administration should be delayed in patients with an active infection until the infection is resolved. g. significant neutropenia or lymphopenia).

Progressive multifocal leukoencephalopathy Since John Cunningham (JC) virus infection resulting in progressive multifocal leukoencephalopathy (PML) has been observed in patients treated with anti-CD20 antibodies, other MS therapies, and ofatumumab at substantially higher doses in oncology indications, physicians should be vigilant for medical history of PML and for any clinical symptoms or MRI findings that may be suggestive of PML.

1. 4). 4). Known active malignancy.