Prescribing information (external link)
KESIMPTA®▼ (ofatumumab) dosing and administration
KESIMPTA 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
All patient imagery on this webpage is fictional and used for illustrative purposes only.
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.1
For full safety information, please refer to the KESIMPTA® Summary of Product Characteristics (SmPC).1 Learn more about the KESIMPTA safety profile.
KESIMPTA (20 mg) offers 1 minute-a-month self-administration (after preparation), at home or on the go, giving patients the independence to administer KESIMPTA in an appropriate environment of their choice.*1,2
*The first subcutaneous injection of KESIMPTA must be performed under the guidance of an HCP.1 ‘1 minute a month’ refers to the time it takes for a patient to inject a full dose; based on stability data.2 Take the pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature. Additional time is required to prepare the pen and clean the administration site.1,3
View commonly asked questions about KESIMPTA dosing and administration
Teaching patients to self-inject? Watch the HCP guidance video
The first subcutaneous injection must be performed under the guidance of an HCP
Ongoing blood monitoring is required in patients with positive hepatitis B serology. Please see the SmPC for details on monitoring of these patients.
20 mg/0.4 mL single-dose pre-filled KESIMPTA (Sensoready®) pen
No dose modifications are expected for patients with renal or hepatic impairment
If a KESIMPTA dose is missed, administer as soon as possible without waiting until the next scheduled dose; subsequent dose should be administered at the recommended intervals
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
The safety and efficacy of KESIMPTA in children aged 0 to 18 years has not yet been established. No data are available
Hypersensitivity to the active substance or to any of the excipients
Patients in a severely immunocompromised state
Severe active infection until resolution
Known active malignancy
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
- There is a limited amount of data from the use of KESIMPTA in pregnant women. KESIMPTA may cross the placenta and cause foetal B-cell depletion based on findings from animal studies
- 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 Cavg and Cmax 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 breast-fed child cannot be excluded during the first few days after birth. Afterwards, KESIMPTA could be used during breast-feeding if clinically needed. However, if the patient was treated with KESIMPTA up to the last few months of pregnancy, breast-feeding can be started immediately after birth
KESIMPTA administration
KESIMPTA is intended for patient self-administration with the Sensoready® Pen, after initial guidance from an HCP.1 Please refer to the KESIMPTA SmPC for administration details.
To help support you when teaching patients on how to administer KESIMPTA after the initial dose, watch the video or view the guide for step-by-step instructions on using the Sensoready® Pen, where to inject and how to correctly administer KESIMPTA:
KESIMPTA dosing and administration guide
KESIMPTA Sensoready® Pen: self-injection video – healthcare professionals instructions
Sensoready® Pen allows patients to inject independently1,4
In a US real-world survey:†5 | |
Image
| of patients found the KESIMPTA Sensoready® Pen easy to use overall (n/N=94/105) |
To request a demonstration kit, please reach out to your Novartis Key Account Manager or click the ‘Contact us’ button below
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 requires no premedications, post-loading dose injection monitoring or dose modification1
Self-administered subcutaneously with the Kesimpta (Sensoready®) pen1
Travel friendly: can be kept at room temperature for up to one week‡1
If not used, KESIMPTA can then be returned to the refrigerator for a maximum of 7 days1
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.
KESIMPTA is intended for patient self administration with initial guidance of an appropriately trained healthcare professional (HCP).
To educate your patients about the KESIMPTA dosing schedule, you can direct them to a portal specifically designed for patients. Here, prescribed patients may access resources and support.
Additional KESIMPTA dosing information1
Before initiating treatment, KESIMPTA’s safety profile and KESIMPTA’s prescribing information should be reviewed. Please refer to the SmPC for further information.
Injectable subcutaneous solution
Dose modifications
Missed doses
Adults over 55 years old
Paediatric population
Contraindications
Women of childbearing potential
Pregnancy
Breast-feeding
KESIMPTA storage
Keep the KESIMPTA pen in its outer carton in order to protect from light1
Store in the refrigerator between 2°C and 8°C.
Do not freeze1
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 days1
What if a patient misses a KESIMPTA dose?
If a patient misses a dose, it should be administered as soon as possible without waiting until the next scheduled dose. Subsequent doses should be administered at the recommended intervals.1
When can a patient self administer KESIMPTA at home?
The first injection should take place under the guidance of an HCP.3 After that, a patient can self-administer at home or another appropriate location outside the hospital setting.
How will a patient know when the injection is complete?
During the injection, they will hear two loud clicks:3
The first click indicates that the injection has started
The second click indicates that the injection is almost complete
The patient must keep holding the pen firmly against their skin until the green indicator fills the window and stops moving. When it stops moving, the injection is complete and the KESIMPTA Sensoready® Pen can be removed.3
For step-by-step instructions on how to administer KESIMPTA with the Sensoready® Pen, watch ‘KESIMPTA Sensoready® Pen: Self-injection video – Healthcare Professional Instructions’.
What are the storage requirements for KESIMPTA?
KESIMPTA needs to be stored in a refrigerator between 2°C and 8°C. Do not freeze.1
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.1
*The first subcutaneous injection must be performed under the guidance of an HCP.1 ‘1 minute a month’ refers to the time it takes for a patient to inject a full dose; based on stability data.2 Take the pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature. Additional time is required to prepare the pen and clean the administration site.1,3 Please refer to the SmPC for administration details.
†Nurses (N=50) and patients (N=80) agree:6
Scores: highly rated (>8.0), mid-rated (7.0-8.0), low rated (<7.0)
- Easy to perform the self-injection with the KESIMPTA Pen: nurses vs patients score 9.6 vs 9.3
- Patient able to use independently: nurses vs patients score 9.3 vs 9.4
- Easy to prepare and set up the KESIMPTA Pen: nurses vs patients score 9.5 vs 9.3
Patient survey: A cross-sectional survey of adult patients with RMS (N=105) in the US who self-administered KESIMPTA with the KESIMPTA pen within the previous 12 months. A total of eight attributes of KESIMPTA pen were assessed, including 'administration time', 'overall ease of use', 'ease of monthly dosing schedule', 'time required to device preparation', 'ease of device preparation', 'device ergonomics' and 'portability.5
Nurse and patient survey: multicentre survey including 50 MS nurses and 80 MS patients aimed to investigate their preference for using the KESIMPTA® Sensoready Pen vs other autoinjector devices. The pilot survey was conducted in Germany, followed by 45-minute, in-field interviews across the US, Germany, France and Italy.6
‡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; MoA, mechanism of action; MS, multiple sclerosis; RMS, relapsing forms of multiple sclerosis; SmPC, summary of product characteristics.
References
KESIMPTA (ofatumumab) Summary of Product Characteristics.
Novartis Data on File. Ofatumumab (OFA005). September 2022.
KESIMPTA (ofatumumab) Patient Information Leaflet. Available at: https://www.medicines.org.uk/emc/product/12433/pil [Accessed August 2026].
Novartis Data on File. Ofatumumab (OFA22). June 2024.
Ross AP, et al. BMC Neurol 2025;25(1):28.
Novartis Data on file. OFA005. September 2022.
UK | August 2026 | 443398-2
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
