In Ireland, KESIMPTA® (ofatumumab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.¹

For full safety information, please refer to the KESIMPTA Summary of Product Characteristics.

The recommended dose is 20 mg KESIMPTA administered by subcutaneous injection with:

Initial dosing at weeks 0, 1 and 2, followed by
Subsequent monthly dosing, starting at week 4.

KESIMPTA dosing and administration

Following the initial dosing period, KESIMPTA offers a 1 minute-a-month self-administration (after preparation), at home or on the go, giving patients the independence to administer their treatment in an appropriate environment of their choice*^1,2

KESIMPTA is intended for patient self-administration, with initial guidance from an appropriately trained HCP.¹ The flexibility to self-administer without the need for HCP involvement means dosing can occur at home or elsewhere appropriate outside the hospital setting. ‘1 minute a month’ refers to the time it takes for a patient to inject a full dose of KESIMPTA; based on stability data.²

Image of the KESIMPTA® Sensoready® pen.

After an initial dosing period, KESIMPTA is self-administered once monthly (20 mg) as a subcutaneous (SC) B-cell therapy for adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features²

Dosing
Storage
KESIMPTA administration

KESIMPTA dosing guidance

Initial doses of KESIMPTA are at Weeks 0, 1 and 2. The once-monthly dosing schedule begins at Week 4. All doses are 20 mg/0.4 mL formulation and are administered via subcutaneous injection.¹

KESIMPTA is intended for patient self-administration with initial guidance of an appropriately trained HCP. After the initial dosing period, KESIMPTA 20 mg is self-administered once monthly at home or on the go.¹ This flexibility to self-administer without the need for HCP involvement means dosing can occur at home or elsewhere appropriate outside the hospital setting.

KESIMPTA dosing schedule infographic featuring KESIMPTA starting dose and monthly dosing.

Please see the SmPC for details on monitoring of patients with positive hepatitis B serology. Patients with active hepatitis B disease should not be treated with KESIMPTA.

The first injection of KESIMPTA should be performed under the guidance of a healthcare professional.

Additional KESIMPTA dosing information¹

Before initiating treatment, KESIMPTA’s safety profile and KESIMPTA’s prescribing information should be reviewed.

Pram icon to represent pregnancy.

Pregnancy and lactation

Women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) while receiving KESIMPTA and for 2 months after the last administration of KESIMPTA
Treatment with KESIMPTA should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus
There are limited data on the use of KESIMPTA in women during lactation. There are no data on the effects of KESIMPTA on milk production. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, which is decreasing to low concentrations soon afterwards. Published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. An observational study reported that concentration of KESIMPTA in breast milk was generally low, with C_avg and C_max of less than 0.02 μg/ml in the breast milk of treated lactating women. In the same observational study, five infants with available B cells had normal levels. Eight infants received live vaccines during/after exposure during breast-feeding with no complications. Infants (up to 24 months of age) did not show abnormalities in infections, antibiotic use, hospitalisations or developmental delays. 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
To help determine the effects of KESIMPTA in pregnant women, healthcare professionals are encouraged to report all pregnancy cases and complications that happen during treatment or within 2 months after the last dose of KESIMPTA to the local representative of the marketing authorisation holder, in order to allow monitoring of these patients through the PRegnancy outcomes Intensive Monitoring programme (PRIM). In addition, all adverse pregnancy events should be reported via HPRA Pharmacovigilance website: www.hpra.ie

Special warnings and precautions for use¹

Icon of an injection pen representing injection-related reactions

Injection-related reactions¹

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

icon representing infections.

Infections¹

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)

icon representing infections.

Progressive multifocal leukoencephalopathy (PML)¹

Since John Cunningham virus infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, other MS therapies, and KESIMPTA 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 KESIMPTA should be suspended until PML has been excluded

Circle with the letters HBV.

Hepatitis B virus (HBV) reactivation¹

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

Vaccinations¹

Vaccination with live or live-attenuated vaccines is not recommended during treatment with KESIMPTA and after discontinuation until B-cell repletion; all immunisations should be administered according to immunisation guidelines at least 4 weeks prior to initiation of KESIMPTA for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of KESIMPTA for inactivated vaccines
KESIMPTA may interfere with the effectiveness of inactivated vaccines. Inactivated vaccines, whenever possible, should be administered at least 2 weeks prior to initiation of KESIMPTA according to immunisation guidelines
The safety of immunisation with live or live-attenuated vaccines following KESIMPTA therapy has not been studied

Vaccination of infants born to mothers treated with KESIMPTA during pregnancy¹

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

This is not an exhaustive list of warnings and precautions.

Please refer to KESIMPTA Prescribing Information and SmPC for further information.

Dosing
Storage
KESIMPTA administration

KESIMPTA storage guidance¹

Refrigerator icon.

Keep the KESIMPTA pen in its outer carton in order to protect from light
Store in the refrigerator between 2 °C and 8 °C. Do not freeze
If necessary, KESIMPTA may be stored unrefrigerated for a single period of up to 7 days at room temperature (not above 30 °C). If not used during this period, KESIMPTA can then be returned to the refrigerator for a maximum of 7 days

Dosing
Storage
KESIMPTA administration

KESIMPTA administration

KESIMPTA is the first and only self-administered once-monthly (20 mg), subcutaneous (SC) B-cell therapy for adults with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.¹

KESIMPTA is intended for patient self-administration with initial guidance from a healthcare professional (HCP). Please refer to the KESIMPTA Summary of Product Characteristics for further information.¹

Watch this video to learn more about how to use KESIMPTA. This will help you teach your patients how to administer KESIMPTA with the Sensoready® pen after the initial dose.

infographic identifying the features of the Sensoready® pen including the viewing window, the concealed needle and the ergonomic shape.

KESIMPTA offers 1 minute a month self-administration outside the hospital setting¹

Please see the SmPC for details on monitoring of patients with positive hepatitis B serology. Patients with active hepatitis B disease should not be treated with KESIMPTA.

Patients with severe active infection should not be treated with KESIMPTA until resolution.

In a US real-world survey:⁴

Information for patients can be found on our Patient Resource page

*Patient must take the pen out of the refrigerator about 15 to 30 minutes before self-administration to allow it to reach room temperature. Additional
time is required to prepare the pen and clean the administration site.¹
^†Store in a refrigerator (2°C–8°C). Do not freeze. If necessary, KESIMPTA may be stored unrefrigerated for a single period of up to 7 days at room temperature (not above 30°C). If not used during this period, KESIMPTA can then be returned to the refrigerator for a maximum of 7 days. Please refer to the SmPC for full administration details.¹

HCP, healthcare professional; HPRA, Health Products Regulatory Authority; IgE, immunoglobulin E; IgG, immunoglobulin G; MS, multiple sclerosis; PRIM, PRegnancy outcomes Intensive Monitoring programme; RMS, relapsing forms of multiple sclerosis; SC, subcutaneous; SIRR, systemic injection-related reaction; SmPC, summary of product characteristics.

References

KESIMPTA (ofatumumab) Summary of Product Characteristics. Available at www.medicines.ie.
Novartis Data on File. Ofatumumab (OFA005). September 2022.
Novartis Data on File. Ofatumumab (OFA22). June 2024.
Ross AP, et al. Poster LB09. Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting; 31 May – 3 June 2023, Aurora, US.

Safety profile

ASCLEPIOS and ALITHIOS clinical trials and efficacy

Downloadable resources

IE11499629 | July 2026

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.