b'Consumer Brief SummaryConsumer Brief SummaryThe risk information provided here is not comprehensive. ThisDo not use KESIMPTA if you:The risk information provided here is not comprehensive.It is not known if KESIMPTA is safe or effective in children.information does not take the place of talking with your doctorhave active hepatitis B virus infection.This information does not take the place of talking withDo not use KESIMPTA if you:about your medical condition or treatment.your doctor about your medical condition or treatment.To learn more about KESIMPTA (ofatumumab) injections, talk tohave had an allergic reaction to ofatumumab or life-have active hepatitis B virus infection.To learn more about KESIMPTA (ofatumumab) injections,threatening injection-related reaction to KESIMPTA.your doctor or pharmacist. For more information and to obtain talk to your doctor or pharmacist. For more informationhave had an allergic reaction to ofatumumab or life-and to obtain the FDA-approved product labeling, callBefore using KESIMPTA, tell your health care provider about the FDA-approved product labeling, call 1-888-669-6682 or visitthreatening injection-related reaction to KESIMPTA.www.kesimpta.com. all of your medical conditions, including if you:1-888-669-6682 or visit www.kesimpta.com. Before using KESIMPTA, tell your health care provider What is the most important information I should know abouthave or think you have an infection, including HBV or PML. What is the most important information I should know about all of your medical conditions, including if you:KESIMPTA? See What is the most important information I should know about KESIMPTA? have or think you have an infection, including HBV or about KESIMPTA?KESIMPTA can cause serious side effects, including: PML. See What is the most important information I KESIMPTA can cause serious side effects, including: have ever taken, currently take, or plan to take medicines that should know about KESIMPTA?Infections. Serious infections, which can be life-threateningaffect your immune system. These medicines could increase your Infections. Serious infections, which can be life-threatening or or cause death, can happen during treatment withave ever taken, currently take, or plan to take medicines hcause death, can happen during treatment with KESIMPTA. Ifrisk of getting an infection.that affect your immune system. These medicines could KESIMPTA. If you have an active infection, your health carehave had a recent vaccination or are scheduled to receive you have an active infection, your health care provider should delay your treatment with KESIMPTA until your infection is gone.increase your risk of getting an infection.provider should delay your treatment with KESIMPTA until KESIMPTA taken before or after other medicines that weakenany vaccinations.your infection is gone. KESIMPTA taken before or after othere had a recent vaccination or are scheduled to havthe immune system may increase your risk of getting infections.oYou should receive any required live or live-attenuated medicines that weaken the immune system may increasereceive any vaccinations.your risk of getting infections.vaccines at least 4 weeks before you start treatment with Tell your health care provider right away if you have anyYou should receive any required live or live-KESIMPTA. You should not receive live or live-attenuated infections or get any symptoms including painful and frequentvaccines while you are being treated with KESIMPTA and Tell your health care provider right away if you have anyattenuated vaccines at least 4 weeks before you urination, nasal congestion, runny nose, sore throat, fever, chills, infections or get any symptoms including painful andstart treatment with KESIMPTA. You should not cough, or body aches.until your health care provider tells you that your immune frequent urination, nasal congestion, runny nose, sorereceive live or live-attenuated vaccines while you system is no longer weakened.Hepatitis B virus (HBV) reactivation. Before startingare being treated with KESIMPTA and until your health throat, fever, chills, cough, or body aches. oWhenever possible, you should receive any non-live treatment with KESIMPTA, your health care provider willcare provider tells you that your immune system is no epatitis B virus (HBV) reactivation. Before startingvaccines at least 2 weeks before you start treatment with Hdo blood tests to check for HBV. If you have ever had HBVlonger weakened.treatment with KESIMPTA, your health care provider willKESIMPTA. infection, the HBV may become active again during or after do blood tests to check for HBV. If you have ever hadWhenever possible, you should receive any non-livetreatment with KESIMPTA. Hepatitis B virus becoming activeoTalk to your health care provider about vaccinations for HBV infection, the HBV may become active again duringvaccines at least 2 weeks before you start treatment again (called reactivation) may cause serious liver problemsyour baby if you used KESIMPTA during your pregnancy.or after treatment with KESIMPTA. Hepatitis B viruswith KESIMPTA. including liver failure or death. You should not receiveare pregnant, think that you might be pregnant, or planbecoming active again (called reactivation) may cause KESIMPTA if you have active hepatitis B liver disease. YourTalk to your health care provider about vaccinations serious liver problems including liver failure or death. Youto become pregnant. It is not known if KESIMPTA will harm your health care provider will monitor you for HBV infection duringfor your baby if you used KESIMPTA during your should not receive KESIMPTA if you have active hepatitisunborn baby. Females who can become pregnant should use and after you stop using KESIMPTA. Tell your health carepregnancy.B liver disease. Your health care provider will monitorbirth control (contraception) during treatment with KESIMPTA provider right away if you get worsening tiredness or yellowingand for 6 months after your last treatment. Talk with your health are pregnant, think that you might be pregnant, or planyou for HBV infection during and after you stop using of your skin or white part of your eyes during treatment withto become pregnant. It is not known if KESIMPTA will harm KESIMPTA. Tell your health care provider right away if care provider about what birth control method is right for you KESIMPTA.your unborn baby. Females who can become pregnant you get worsening tiredness or yellowing of your skin orduring this time.Progressive Multifocal Leukoencephalopathy (PML). PMLshould use birth control (contraception) during treatmento Pregnancy Registry: There is a registry for women who white part of your eyes during treatment with KESIMPTA. may happen with KESIMPTA. PML is a rare, serious brainwith KESIMPTA and for 6 months after your last treatment. become pregnant during treatment with KESIMPTA. Progressive Multifocal Leukoencephalopathy (PML).infection caused by a virus that may get worse over daysTalk with your health care provider about what birth control PML may happen with KESIMPTA. PML is a rare, seriousIf you become pregnant while taking KESIMPTA, tell or weeks. PML can result in death or severe disability. Tellmethod is right for you during this time.brain infection caused by a virus that may get worseyour healthcare provider right away. Talk to your health your health care provider right away if you have any new orcare provider about registering with the MotherToBaby over days or weeks. PML can result in death or severePregnancy Registry: There is a registry for women who worsening neurologic signs or symptoms. These may includePregnancy Study in Multiple Sclerosis. The purpose of the disability. Tell your health care provider right away ifbecome pregnant during treatment with KESIMPTA. If you weakness on one side of your body, loss of coordinationregistry is to collect information about your health and become pregnant while taking KESIMPTA, tell your health in arms and legs, vision problems, changes in thinking and you have any new or worsening neurologic signs oryour babys health. For more information or to register, care provider right away. Talk to your health care provider memory which may lead to confusion and personality symptoms. These may include weakness on one side ofcontact MotherToBaby by calling 1-877-311-8972, by changes.about registering with the MotherToBaby Pregnancy your body, loss of coordination in arms and legs, visionsending an email to MotherToBaby@health.ucsd.edu, or go Study in Multiple Sclerosis. The purpose of the registry problems, changes in thinking and memory which mayto www.mothertobaby.org/join-study.Weakened immune system. KESIMPTA taken before or afteris to collect information about your health and your lead to confusion and personality changes.other medicines that weaken the immune system could increaseare breastfeeding or plan to breastfeed. It is not known ifbabys health. For more information or to register, contact KESIMPTA passes into your breast milk. Talk to your health your risk of getting infections.Weakened immune system. KESIMPTA taken before orMotherToBaby by calling 1-877-311-8972, by sending an after other medicines that weaken the immune systemcare provider about the best way to feed your baby if you What is KESIMPTA? email to MotherToBaby@health.ucsd.edu, or go to www.could increase your risk of getting infections. take KESIMPTA.KESIMPTA is a prescription medicine used to treat adults withmothertobaby.org/join-study.What is KESIMPTA? e breastfeeding or plan to breastfeed. It is not known relapsing forms of multiple sclerosis (MS) including: Tell your health care provider about all the medicines you ar take, including prescription and over-the-counter medicines, KESIMPTA is a prescription medicine used to treat adultsif KESIMPTA passes into your breast milk. Talk to yourclinically isolated syndromevitamins, and herbal supplements.with relapsing forms of multiple sclerosis (MS) including: health care provider about the best way to feed your relapsing-remitting disease baby if you take KESIMPTA.Know the medicines you take. Keep a list of them to show your clinically isolated syndrome health care provider and pharmacist when you get a new active secondary progressive disease Tell your health care provider about all the medicines medicine.relapsing-remitting disease you take, including prescription and over-the-counterIt is not known if KESIMPTA is safe or effective in children.active secondary progressive disease'