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
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
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 features1
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 requires no premedications, ongoing monitoring or dose modification1
Self-administered subcutaneously with the KESIMPTA (Sensoready®) pen1
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.
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. The first injection of KESIMPTA should be performed under the guidance of a healthcare professional.
You can learn more about B-cell therapy by reviewing KESIMPTA’s mechanism of action
Additional KESIMPTA dosing information1
Before initiating treatment, KESIMPTA’s safety profile and KESIMPTA’s prescribing information should be reviewed.
Injectable subcutaneous solution
20 mg/0.4 mL single-dose pre-filled KESIMPTA (Sensoready®) pen
Dose modifications
No dose modifications are expected for patients with renal or hepatic impairment
Missed doses
If a dose is missed, administer as soon as possible without waiting until the next scheduled dose; subsequent dose should be administered at the recommended intervals
Adults over 55 years old
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
Paediatric population
The safety and efficacy of KESIMPTA in children aged 0 to 18 years has not yet been established. No data are available
Pregnancy and lactation
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
Contraindications
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
KESIMPTA storage guidance1
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
KESIMPTA administration
KESIMPTA is the first and only self-administered once-monthly (20 mg), subcutaneous (SC) B-cell therapy for 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.
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.
Information for patients can be found on our patient resource page.
KESIMPTA is generally easy to use†1
No premedications1
No ongoing monitoring1
No dose modifications1
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.
In a US real-world survey:4
of patients found the KESIMPTA pen to be 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
*Patient must take the pen out of the refrigerator about 15–30 minutes before self-administration to allow it to reach room temperature. Additional time is required to prepare the pen and cleanse. 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
†Based on 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 seven attributes of the KESIMPTA pen were assessed, including ‘administration time’, ‘ease of monthly dosing schedule’ and ‘portability’.4
‡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; MS, multiple sclerosis; RMS, relapsing forms of MS; SC, subcutaneous; SmPC, summary of product characteristics.
References
KESIMPTA (ofatumumab) Summary of Product Characteristics.
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.
UK | January 2025 | 443398
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.