

KESIMPTA AND VACCINES
KESIMPTA® (ofatumumab) and vaccines
Live and live-attenuated vaccines1,2
(eg, chickenpox, measles)*
Non-live and inactivated vaccines1,2
(eg, hepatitis A, polio, influenza, and SARS-CoV-2 vaccines)*
For new patients planning to start KESIMPTA
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Administer at least 4 weeks prior to initiation of KESIMPTA
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Whenever possible, administer at least 2 weeks prior to initiation of KESIMPTA
For patients already taking KESIMPTA
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Not recommended during treatment†
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Administer live vaccines only after B-cell repletion
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In the pivotal trials, concomitant treatment with non-live vaccines was permitted
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The use of non-live vaccines is not contraindicated with KESIMPTA therapy
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KESIMPTA may interfere with the effectiveness of inactivated vaccines†
KESIMPTA® (ofatumumab) and vaccines
Live and live-attenuated vaccines1,2
(eg, chickenpox, measles)*
For new patients planning to start KESIMPTA
-
Administer at least 4 weeks prior to initiation of KESIMPTA
For patients already taking KESIMPTA
-
Not recommended during treatment†
-
Administer live vaccines only after B-cell repletion
Non-live and inactivated vaccines1,2
(eg, hepatitis A, polio, influenza, and SARS-CoV-2 vaccines)*
For new patients planning to start KESIMPTA
-
Whenever possible, administer at least 2 weeks prior to initiation of KESIMPTA
For patients already taking KESIMPTA
-
In the pivotal trials, concomitant treatment with non-live vaccines was permitted
-
The use of non-live vaccines is not contraindicated with KESIMPTA therapy
-
KESIMPTA may interfere with the effectiveness of inactivated vaccines†
Vaccination of infants born to mothers treated with KESIMPTA during pregnancy1*†
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In infants of mothers treated with KESIMPTA during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts. Depletion of B cells in these infants may increase the risks from live or live-attenuated vaccines‡
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Inactivated vaccines may be administered, as indicated, prior to recovery from B-cell depletion, but an assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted‡
Currently available COVID-19 vaccines on the market, by Pfizer/BioNTech, Moderna, and Janssen, are non-live vaccines.3
Any vaccine used in patients taking KESIMPTA should be administered in accordance with the KESIMPTA full Prescribing Information.
Immune response
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B cells are part of a complex immune response to both viruses and vaccinations4,5
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T cells are also involved and play a fundamental role in viral infections by helping B cells produce antibodies. They also orchestrate the response for other immune cells. Some T cells kill infected cells to reduce the viral burden4,5
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Data from an RMS clinical study also showed that T cells remained largely unaffected in KESIMPTA-treated patients. T cells are an important part of a response to viral infections, including COVID-195,6
KESIMPTA is a targeted and precisely delivered B-cell therapy
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When delivered subcutaneously, KESIMPTA is thought to promote preferential depletion of B cells in the lymph nodes7
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Preclinical evidence suggests that KESIMPTA may spare B cells in the spleen that help maintain immune function8
The precise mechanism by which KESIMPTA exerts its therapeutic effects is unknown.
Read more on KESIMPTA vaccine-related information

Read more on KESIMPTA vaccine-related information
DOWNLOAD BROCHURE*As of March 2021, KESIMPTA has not been studied with vaccines.
†Post vaccination, an assessment of vaccine immune responses, including consultation with qualified specialists, should be considered to determine whether a protective immune response was mounted. It is unknown whether KESIMPTA may interfere with vaccine efficacy.
‡Data from Studies 1 and 2 indicate a median time to B-cell recovery to either LLN or baseline value of 24.6 weeks post-treatment discontinuation. PK and PD modeling and simulation for B-cell repletion corroborate these data, predicting median time to B-cell recovery to LLN of 23 weeks post-treatment discontinuation.
DIGITAL EDUCATION LAB
Watch an expert panel discuss KESIMPTA patients who may need vaccinations.
The Summit on KESIMPTA: KESIMPTA and Vaccines

Watch an expert panel discuss KESIMPTA patients who may need vaccinations.
The Summit on KESIMPTA: KESIMPTA and Vaccines
GO TO VIDEO
Start patients on KESIMPTA today
DOWNLOAD START FORMSubmit a Start Form by fax or online at CoverMyMeds®
VISIT COVERMYMEDS®MOA=mechanism of action; RMS=relapsing multiple sclerosis; SC=subcutaneous.
References: 1. Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. Centers for Disease Control and Prevention. Principles of vaccination. Updated August 18, 2021. Accessed February 10, 2022. https://www.cdc.gov/vaccines/pubs/pinkbook/prinvac.html 3. Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. Updated February 22, 2022. Accessed March 11, 2022. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html 4. Centers for Disease Control and Prevention. Understanding How COVID-19 Vaccines Work. Updated January 25, 2022. Accessed February 10, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html 5. Vabret N, Britton GJ, Gruber C, et al. Immunology of COVID-19: current state of the science. Immunity. 2020;52(6):910-941. doi:10.1016j.immuni.2020.05.002 6. Wiendl H, Fox E, Goodyear A, et al. Effect of subcutaneous ofatumumab on lymphocyte subsets in patients with RMS: analysis from the APLIOS study. LB129. Poster presented at: 6th Congress of the European Academy of Neurology; May 23-26, 2020; Paris, France; Virtual. 7. Torres JB, Roodselaar J, Sealey M, et al. Distribution and efficacy of ofatumumab and ocrelizumab in humanized-CD20 mice following subcutaneous or intravenous administration. P2.2-052. Poster presented at: 71st American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. 8. Theil D, Smith P, Huck C, et al. Imaging mass cytometry and single-cell genomics reveal differential depletion and repletion of B-cell populations following ofatumumab treatment in cynomolgus monkeys. Front lmmunol. 2019;10:1-11.