KESIMPTA® (ofatumumab) is the first and only self-administered SC B-cell treatment for RMS1,2
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Dosing
KESIMPTA is taken in 1 minute a month when the patient is ready to self-administer—at home or on the go1,3*†
So they can spend their time, their way
To help patients understand dosing with KESIMPTA, share the instructions below:
Initial dosing of 20 mg by SC injection at weeks 0, 1, and 2, followed by subsequent dosing of 20 mg by SC injection once monthly starting at week 4. After initial dosing, KESIMPTA is administered once monthly.1
First dose
The first injection should be performed in the guidance of a health care professional.1
Missed doses
Administer as soon as possible without waiting until the next scheduled dose; subsequent doses should be administered at the recommended intervals.1
The KESIMPTA Phase 2 trial determined that once-monthly frequency in a low SC dose was comparably effective, with fewer side effects, vs higher SC doses.4,5
The KESIMPTA (20 mg) dose was chosen through dose modeling based on B-cell depletion results and Phase 2 data.4,5
See the Starting Patients page for information on screening and testing prior to starting treatment with KESIMPTA
†KESIMPTA Sensoready® Pens must be refrigerated at 2°C to 8°C (36°F to 46°F). Keep product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake. If necessary, KESIMPTA may be stored at room temperature below 30°C (86°F) for up to 7 days and returned to the refrigerator, to be used within the next 7 days.1
‡Based on a cross-sectional survey of adult RMS patients (N=105) in the US who self-administered KESIMPTA with the Sensoready Pen within the previous 12 months. A total of 8 attributes of KESIMPTA Pen use were assessed, including “easy and simple to use,” “easy to prepare,” and “convenient/flexible to travel with.” 89.5% of patients scored a 4 or 5 on characteristics of overall ease of use and ease of monthly dosing schedule. Questionnaire has not been validated. Initiation of KESIMPTA in patients may be influenced by insurance and availability (among other issues). Hence, data should be cautiously interpreted.6,7
The Pen
How KESIMPTA is administered
KESIMPTA is delivered via pre-filled, easy-to-use autoinjector pen1*
Please see Instructions for Use for more detailed instructions on preparation and administration of KESIMPTA.
Show your patients how a real patient self-administers KESIMPTA
Watch Zenovia, a real patient, administer KESIMPTA with the easy-to-use* Sensoready Pen
Self-administration summary
See the KESIMPTA difference
This chart is only intended to show administration times. No conclusions of comparative efficacy and safety should be drawn. KESIMPTA is administered in 1 minute a month subcutaneously. Ocrevus and Briumvi are administered twice yearly via infusion. Please refer to each product’s specific prescribing information for complete dosing and administration instructions.
This chart is only intended to show administration times. No conclusions of comparative efficacy and safety should be drawn. KESIMPTA is administered in 1 minute a month subcutaneously. Ocrevus Zunovo is administered twice yearly via subcutaneous injection administered by a health care professional. Please refer to each product’s specific prescribing information for complete dosing and administration instructions.
Request KESIMPTA samples and a demo station to aid in your patient discussions
†Only limited benefit of premedication with corticosteroids, antihistamines, or acetaminophen was observed in RMS clinical studies. The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. If injection-related reactions occur, symptomatic treatment is recommended.1
‡KESIMPTA Sensoready Pens must be refrigerated at 2°C to 8°C (36°F to 46°F). Keep product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake. If necessary, KESIMPTA may be stored at room temperature below 30°C (86°F) for up to 7 days and returned to the refrigerator, to be used within the next 7 days.1
§Based on a survey of multiple sclerosis (MS) nurses (N=50) and patients (N=80) in the US, Germany, France, and Italy. Participants were asked to compare attributes of the KESIMPTA Sensoready autoinjector pen with those of other DMT autoinjectors, some of which are not available in the US. The Sensoready Pen was not injected during the survey nor were all devices compared against each other by participants. A total of 17 attributes were assessed, with “easy to perform self-injection with the pen,” “ease of preparation and set-up,” and “ease of training patient in use” among those most preferred.11
Persistence Data
Patients who start KESIMPTA, stay on KESIMPTA
KESIMPTA persistence and adherence vs other first-line options
*Persistence was defined as the number of days from the index date until discontinuation or a switch to a new DMT. It was measured during the post index period, which included the index date. Discontinuation was defined as a >60-day gap in therapy (injectables) or >90-day gap (orals) of the index medication, defined as a gap between the last supply date (based on expected duration of treatment or days’ supply) and the next claim date for the index therapy.12,13
Learn more about adherence and persistence from your peers
†Study 1: retrospective cohort study of adult RMS patients treated with KESIMPTA (n=333) vs platform injectables (n=333) (glatiramer acetate, interferon beta-1a/1b, and peginterferon beta-1a).12
Study 2: retrospective cohort study of adult RMS patients treated with KESIMPTA (n=576) or oral DMTs (n=576) (dimethyl fumarate, fingolimod, teriflunomide, cladribine, siponimod, ozanimod, diroximel fumarate, monomethyl fumarate, and ponesimod).13
Both studies were conducted from August 2020 to November 2021, utilizing the IQVIA PharMetrics® Plus database. Patients were indexed on first observed therapy and followed until discontinuation, switch, or 12 months post index for persistent patients. Propensity score matching was used to balance the baseline demographic, clinical, and RMS characteristics, as well as use of prior DMT between cohorts.12,13
Analyses using claims data are dependent on the accuracy and specificity of information provided. Early discontinuation may be overestimated if treatment occurred outside the purview of the claims data source. Caution should be exercised in making any direct comparisons due to differences between DMTs.12,13
IQVIA PharMetrics® Plus is a longitudinal health plan database of medical and pharmacy claims in the United States.
†Treatment-naïve was defined as patients not on any treatment prior to starting the clinical trials. This includes patients who started on KESIMPTA and patients who switched from teriflunomide to KESIMPTA.14
References: 1. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp. 2. National Multiple Sclerosis Society. Injectable Therapies. Accessed May 28, 2024. https://www.nationalmssociety.org/article/injectable-therapies 3. Data on file. Injection time. Novartis Pharmaceuticals Corp; East Hanover, NJ. June 2020. 4. Bar-Or A, Grove RA, Austin DJ, et al. Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: the MIRROR study. Neurology. 2018;90(20):e1805-e1814. doi:10.1212/WNL.0000000000005516 5. Sorensen PS, Lisby S, Grove R, et al. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. Neurology. 2014;82:573-581. 6. Ross AP, Nicholas J, Tai MH, et al. Real-world satisfaction and experience with injection and autoinjector device for ofatumumab indicated for multiple sclerosis. LB09. Presented at: Consortium of Multiple Sclerosis Centers Annual Meeting; May 31-June 3, 2023; Aurora, CO. 7. Novartis KESIMPTA Sensoready® pen survey HEORUSV201392. June 2022. 8. Ocrevus. Prescribing information. Genentech, Inc. 9. Briumvi. Prescribing information. TG Therapeutics, Inc. 10. Ocrevus Zunovo. Prescribing information. Genentech, Inc. 11. Ross AP, Besser C, Stoneman S, Gaunt H, Barker N. Patient and nurse preferences for the Sensoready® autoinjector pen versus other autoinjectors in multiple sclerosis: results from a multicenter survey. Poster P210. Presented at: ACTRIMS Forum; February 25-27, 2021; Virtual. 12. Gorritz M, Chen CC, Tuly R, et al. Real-world persistence and adherence to ofatumumab versus other self-injectable disease modifying therapies (DMTs) in patients with multiple sclerosis (MS). DMT25. Presented at: 2023 CMSC Annual Meeting; May 31-June 3, 2023; Aurora, CO. 13. Gorritz M, Chen CC, Tuly R, et al. Real-world persistence of ofatumumab versus oral disease modifying therapies (DMTs) in patients with multiple sclerosis (MS). LB15. Presented at: 2023 CMSC Annual Meeting; May 31-June 3, 2023; Aurora, CO. 14. Pardo G, Hauser SL, Bar-Or A, et al. Longer-term (up to 6 years) efficacy of ofatumumab in people with recently diagnosed and treatment-naive relapsing multiple sclerosis. S31.003. Presented at: 76th American Academy of Neurology Annual Meeting; April 13-18, 2024; Denver, CO.