Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

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.

Injection-related reactions

Patients should be informed that systemic injection-related reactions (SIRRs) could occur, generally within 24 hours and predominantly following the first injection (see section 4.8).
Symptoms most frequently observed in RMS clinical studies include fever, headache, myalgia, chills, fatigue, nausea and vomiting and were predominantly (99.8%) mild to moderate in severity. There were no life-threatening SIRRs reported in RMS clinical studies (see section 4.8).

Additional SIRRs reported in the post-marketing setting include rash, urticaria, dyspnoea and angioedema (e.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.


KES API JUL24 V5                           Page 2 of 15                  EU SmPC 06/2024 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. Patients with known IgE-mediated hypersensitivity to ofatumumab must not be treated with ofatumumab (see section 4.3).

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.

Injection site reaction (local) symptoms observed in clinical studies included erythema, swelling, itching and pain (see section 4.8).

The first injection should be performed under the guidance of an appropriately trained healthcare professional (see section 4.2).

Infections

It is recommended to evaluate the patient’s immune status prior to initiating therapy.
Based on its mode of action and available clinical experience, ofatumumab has the potential for an increased risk of infections (see section 4.8).

Administration should be delayed in patients with an active infection until the infection is resolved.

Ofatumumab must not be given to patients in a severely immunocompromised state (e.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. If PML is suspected, treatment with ofatumumab should be suspended until PML has been excluded.

Hepatitis B virus reactivation
Hepatitis B reactivation has occurred in patients treated with anti-CD20 antibodies, which in some cases resulted in fulminant hepatitis, hepatic failure and death.

Patients with active hepatitis B disease should not be treated with ofatumumab. HBV screening should be performed in all patients before initiation of treatment. As a minimum, screening should include hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) testing. These can be complemented with other appropriate markers as per local guidelines. Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult a liver disease expert before the start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.


KES API JUL24 V5                           Page 3 of 15                 EU SmPC 06/2024 Treatment of severely immunocompromised patients

Patients in a severely immunocompromised state must not be treated until the condition resolves (see section 4.3).

It is not recommended to use other immunosuppressants concomitantly with ofatumumab except corticosteroids for symptomatic treatment of relapses.

Vaccinations

All immunisations should be administered according to immunisation guidelines at least 4 weeks prior to initiation of ofatumumab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ofatumumab for inactivated vaccines.

Ofatumumab may interfere with the effectiveness of inactivated vaccines.

The safety of immunisation with live or live-attenuated vaccines following ofatumumab therapy has not been studied. Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until B-cell repletion (see section 4.5). The median time to B-cell recovery to the lower limit of normal (LLN, defined as 40 cells/µl) or baseline value is 24.6 weeks post treatment discontinuation based on data from phase III studies (see section 5.1).

Vaccination of infants born to mothers treated with ofatumumab during pregnancy In infants of mothers treated with ofatumumab during pregnancy live or live-attenuated vaccines should not be administered before the recovery of B-cell counts has been confirmed.
Depletion of B cells in these infants may increase the risks from live or live-attenuated vaccines.

Inactivated vaccines may be administered as indicated prior to recovery from B-cell depletion, however assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted (see section 4.6).

Sodium content

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7   Effects on ability to drive and use machines

Kesimpta has no or negligible influence on the ability to drive and use machines.