KESIMPTA resources
Don’t miss out on these resources to support you and your patients.
Prescribing information (external link)
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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
For full dosing and administration information, please refer to the KESIMPTA Summary of Product Characteristics (SmPC).1
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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 6 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
The use of KESIMPTA in women during lactation has not been studied
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:
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KESIMPTA dosing and administration guide
PDF
Video
5 mins 9 secs
KESIMPTA Sensoready® Pen: self-injection video – healthcare professionals instructions
Video
- 03 Dec 2024
5 mins 9 secs
Sensoready® Pen allows patients to inject independently1,4
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In a US real-world survey:†5 | |
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| 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
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KESIMPTA requires no premedications, post-loading dose injection monitoring or dose modification1
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Self-administered subcutaneously with the Kesimpta (Sensoready®) pen1
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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.
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Injectable subcutaneous solution
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Dose modifications
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Missed doses
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Adults over 55 years old
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Paediatric population
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Contraindications
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Women of childbearing potential
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Pregnancy
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Lactation
KESIMPTA storage
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Keep the KESIMPTA pen in its outer carton in order to protect from light1
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Store in the refrigerator between 2°C and 8°C.
Do not freeze1
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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
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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.
†Based on a cross-sectional survey of adult patients with MS (N=105) in the US who self-administered KESIMPTA with the KESIMPTA Sensoready® Pen within the previous 12 months. A total of seven attributes of the KESIMPTA pen were assessed, including ‘administration time’, ‘ease of monthly dosing schedule’ and ’portability’.5
‡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.
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, CO, US.
UK | May 2026 | 443398-1
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.
