Hypersensitivity to the active substance or to any of the excipients in KESIMPTA

Patients in a severely immunocompromised state

Severe active infection until resolution

Known active malignancy

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Patients in a severely immunocompromised state must not be treated until the condition resolves

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

Women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) while receiving KESIMPTA and for 6 months after the last administration of KESIMPTA, as there is a limited amount of data from the use of KESIMPTA in pregnant women

Treatment with KESIMPTA should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus

KESIMPTA may cross the placenta and cause foetal B-cell depletion based on findings from animal studies

The use of KESIMPTA in women during lactation has not been studied. It is unknown whether KESIMPTA is excreted in human milk. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, and decreases to low concentrations soon afterwards. Consequently, a risk to the breastfed child cannot be excluded during this short period. Afterwards, KESIMPTA could be used during breastfeeding if clinically needed. However, if the patient was treated with KESIMPTA up to the last few months of pregnancy, breastfeeding can be started immediately after birth

There are no data on the effect of KESIMPTA on human fertility

In infants of mothers treated with KESIMPTA 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

It is recommended to evaluate the patient’s immune status prior to initiating therapy

Based on its mode of action and available clinical experience, KESIMPTA has the potential for an increased risk of infections. Administration should be delayed in patients with an active infection until the infection is resolved

KESIMPTA must not be given to patients in a severely immunocompromised state (e.g. significant neutropenia or lymphopenia)

Physicians should be vigilant for medical history of PML and for any clinical symptoms or magnetic resonance imaging findings that may be suggestive of PML. If PML is suspected, treatment with KESIMPTA should be suspended until PML has been excluded

HBV 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 HBV disease should not be treated with KESIMPTA. HBV screening should be performed in all patients before initiation of treatment. As a minimum, screening should include HBV surface antigen (HBsAg) and HBV core antibody (HBcAb) testing. These can be complemented with other appropriate markers as per local guidelines. Patients with positive HBV 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 HBV reactivation

Patients should be informed that systemic injection‑related reactions could occur, generally within 24 hours and predominantly following the first injection

Symptoms most frequently observed in relapsing forms of multiple sclerosis (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 systemic injection‑related reactions reported in RMS clinical studies

Additional systemic injection‑related reactions 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 KESIMPTA treatment, there were also serious cases where patients were able to continue KESIMPTA treatment without further incidents

Some systemic injection‑related reaction symptoms may be clinically indistinguishable from Type 1 acute hypersensitivity reactions (immunoglobulin E (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 KESIMPTA must not be treated with KESIMPTA

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

The first injection should be performed under the guidance of an appropriately trained healthcare professional

The risk of additive immune system effects should be considered when co-administering immunosuppressive therapies with KESIMPTA

When initiating KESIMPTA after other immunosuppressive therapies with prolonged immune effects or initiating other immunosuppressive therapies with prolonged immune effects after KESIMPTA, the duration and mode of action of these medicinal products should be taken into account because of potential additive immunosuppressive effects