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SAFETY AND TOLERABILITY

Demonstrated safety profile

IMPORTANT SAFETY INFORMATION

Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.

WARNINGS AND PRECAUTIONS

Infections: An increased risk of infections has been observed with other anti-CD20 B-cell depleting therapies. KESIMPTA has the potential for an increased risk of infections including serious bacterial, fungal, and new or reactivated viral infections; some have been fatal in patients treated with other anti-CD20 antibodies...

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. Hauser SL, Bar-Or A, Cohen JA, et al; for the ASCLEPIOS I and ASCLEPIOS II trial groups. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med. 2020;383(6):546-557. 2. Conway D, Hersh C, Wang M, Yang F, Deshpande C. Treatment failure in patients with multiple sclerosis initiating frequently used first line therapies. PO02. Poster presented at: 8th Joint ACTRIMS-ECTRIMS Meeting MS; September 11-13, 2020; Virtual. 3. Kesimpta. Prescribing information. Novartis Pharmaceuticals Corp. 4. Data on file. OMB157G (ofatumumab). Summary of clinical safety. Novartis Pharmaceuticals Corp; East Hanover, NJ. January 2020. 5. Cohen JA, Hauser SL, Cross AH, et al. Five-year safety of ofatumumab in people living with relapsing multiple sclerosis. P8.2-004. Presented at: 75th American Academy of Neurology Annual Meeting; April 22-27, 2023; Boston, MA. 6. Hauser SL, Cross AH, Winthrop K, et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022;28(10):1576-1590. 7. Hauser SL, Fox E, Aungst A, et al. Long-term efficacy of ofatumumab in patients with relapsing multiple sclerosis. P5.004. Presented at 74th American Academy of Neurology Annual Meeting; April 2-7, 2022; Seattle, WA. 8. Hauser SL, Cross AH, Winthrop K, et al. Long-term safety of ofatumumab in patients with relapsing multiple sclerosis. S14.004. Presented at 74th American Academy of Neurology Annual Meeting; April 2-7, 2022; Seattle, WA. 9. Kappos L, Cohen JA, Gold R, et al. Five-year efficacy outcomes of ofatumumab in relapsing MS patients: insights from ALITHIOS open-label extension study. EPR-097. Presented at: 9th Congress of the European Academy of Neurology; July 1-4, 2023; Budapest, Hungary. 10. Hauser SL, Bar-Or A, Cohen JA, et al; ASCLEPIOS I and ASCLEPIOS II trial groups. Ofatumumab versus teriflunomide in multiple sclerosis. Supplemental appendix. N Engl J Med. 2020;383(6):546-557. 11. 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 12. 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. 13. Häusser-Kinzel S, Weber MS. The role of B cells and antibodies in multiple sclerosis, neuromyelitis optica, and related disorders. Front Immunol. 2019;10:201. doi:10.3389/fimmu.2019.002021 14. 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. 15. 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 16. Derfuss T, Weber MS, Hughes R, et al. Serum immunoglobulin levels and risk of serious infections in the pivotal phase III trials of ocrelizumab in multiple sclerosis and their open label extensions. OPR-65. Presented at: 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 11-13, 2019; Stockholm, Sweden. 17. Delves PJ. Molecular components of the immune system. Merck Manual. Updated September 2022. Accessed November 3, 2023. https://www.merckmanuals.com/ professional/immunology-allergic-disorders/biology-of-the-immune-system/molecular-components-of-the-immune-system 18. Mayo Clinic Laboratories. Immunoglobulins (IgG, IgA, and IgM), serum. Accessed November 3, 2023. https://neurology.testcatalog.org/show/IMMG 19. Data on file. Novartis Pharmaceuticals Corp; East Hanover, NJ. August 2021. 20. Cross AH, Delgado S, Habek M, et al. COVID-19 outcomes and vaccination in people with relapsing multiple sclerosis treated with ofatumumab. Neurol Ther. 2022;11:741-758. doi:10.1007/s40120-022-00341-z