KESIMPTA AND VACCINES

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 vaccinations^4,5

• 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 burden^4,5

• 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-19^5,6

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.

*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.

Learn how KESIMPTA 20 mg SC is administered

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