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KESIMPTA AND VACCINES
This chart shows information about KESIMPTA and vaccinations.

Vaccination of infants born to mothers treated with KESIMPTA  during pregnancy1*

  • 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

  • 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

  • B cells are part of a complex immune response to both viruses and vaccinations4,5

  • 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

  • Data from a relapsing MS 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

  • When delivered subcutaneously, KESIMPTA is thought to promote preferential depletion of B cells in the lymph nodes7

  • 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.

KESIMPTA vaccine-related information brochure

Read more on KESIMPTA vaccine-related information

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*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.

LLN, lower limit of normal; MOA, mechanism of action; MS, multiple sclerosis; PD, pharmacodynamic; PK, pharmacokinetic; SC, subcutaneous.

IMPORTANT SAFETY INFORMATION

Contraindications: KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema.

Warnings and Precautions

Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies....

INDICATION

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults...

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References: 1. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp. 2. Centers for Disease Control and Prevention. Principles of vaccination. Updated August 18, 2021. Accessed November 7, 2023. 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:10.1016/j.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; 10:1340. doi:10.3389/fimmu.2019.01340