b'Consumer Brief SummaryThe risk information provided here is notWhat is KESIMPTA?comprehensive. This information does not take theKESIMPTA is a prescription medicine used to treat place of talking with your doctor about your medicaladults with relapsing forms of multiple sclerosis (MS) condition or treatment. including:To learn more about KESIMPTA (ofatumumab)clinically isolated syndrome injections, talk to your doctor or pharmacist. For more information and to obtain the FDA-approved productrelapsing-remitting diseaselabeling, call 1-888-669-6682 or visit www.kesimpta.com. active secondary progressive diseaseWhat is the most important information I shouldIt is not known if KESIMPTA is safe or effective in know about KESIMPTA? children.KESIMPTA can cause serious side effects, including: Do not use KESIMPTA if you:Infections. Serious infections can happen duringhave active hepatitis B virus infection.treatment with KESIMPTA. If you have an activeBefore using KESIMPTA, tell your healthcare infection, your healthcare provider should delay yourprovider about all of your medical conditions, treatment with KESIMPTA until your infection is gone.including if you:KESIMPTA taken before or after other medicines thathave or think you have an infection, including weaken the immune system may increase your risk of HBV or PML. See What is the most important getting infections.information I should know about KESIMPTA?Tell your healthcare provider right away if you havehave ever taken, currently take, or plan to take any infections or get any symptoms including painful and frequent urination, nasal congestion, runny nose,medicines that affect your immune system. These sore throat, fever, chills, cough, or body aches.medicines could increase your risk of getting an infection. have had a recent vaccination or are scheduled to Hepatitis B virus (HBV) reactivation. Before startingtreatment with KESIMPTA, your healthcare providerreceive any vaccinations.will do blood tests to check for HBV. If you have everoYou should receive any required live or live-had HBV infection, the HBV may become activeattenuated vaccines at least 4 weeks before again during or after treatment with KESIMPTA.you start treatment with KESIMPTA. You should Hepatitis B virus becoming active again (callednot receive live or live-attenuated vaccines reactivation) may cause serious liver problemswhile you are being treated with KESIMPTA and including liver failure or death. You should notuntil your healthcare provider tells you that your receive KESIMPTA if you have active hepatitis B liverimmune system is no longer weakened.disease. Your healthcare provider will monitor you for HBV infection during and after you stop usingoWhenever possible, you should receive any non-KESIMPTA. Tell your healthcare provider right awaylive vaccines at least 2 weeks before you start if you get worsening tiredness or yellowing of yourtreatment with KESIMPTA. skin or white part of your eyes during treatment oTalk to your healthcare provider about with KESIMPTA.vaccinations for your baby if you used KESIMPTA Progressive Multifocal Leukoencephalopathyduring your pregnancy. (PML). PML may happen with KESIMPTA. PML isare pregnant, think that you might be pregnant,a rare, serious brain infection caused by a virusor plan to become pregnant. It is not known if that may get worse over days or weeks. PMLKESIMPTA will harm your unborn baby. Females can result in death or severe disability. Tell yourwho can become pregnant should use birth control healthcare provider right away if you have any new(contraception) during treatment with KESIMPTA and or worsening neurologic signs or symptoms. Thesefor 6 months after your last treatment. Talk with your may include weakness on one side of your body, losshealthcare provider about what birth control method of coordination in arms and legs, vision problems,is right for you during this time.changes in thinking and memory which may lead toare breastfeeding or plan to breastfeed. It is not confusion and personality changes.known if KESIMPTA passes into your breast milk. Weakened immune system. KESIMPTA taken beforeTalk to your healthcare provider about the best way or after other medicines that weaken the immuneto feed your baby if you take KESIMPTA.system could increase your risk of getting infections. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 11969197_Kesimpta_DTC_JLS_Ad_MS_Focus_M5FR.indd 2 8/24/23 4:09 PM'