b'Important Safety Information (cont)What is the most important information I should Are pregnant, think that you might be pregnant, know about KESIMPTA? or plan to become pregnant. It is not known if KESIMPTA can cause serious side effects such as: KESIMPTA will harm your unborn baby. FemalesInfections. Serious infections can happen duringwho can become pregnant should use birth control treatment with KESIMPTA. If you have an active(contraception) during treatment with KESIMPTA and infection, your healthcare provider (HCP) should delayfor 6 months after your last treatment. Talk with your your treatment with KESIMPTA until your infection isHCP about what birth control method is right for you gone. KESIMPTA taken before or after other medicinesduring this time. that weaken the immune system may increase your Are breastfeeding or plan to breastfeed. It is not risk of getting infections. Tell your HCP right awayknown if KESIMPTA passes into your breast milk. if you have any infections or get any symptomsTalk to your HCP about the best way to feed your including painful and frequent urination, nasalbaby if you take KESIMPTA.congestion, runny nose, sore throat, fever, chills, cough,Tell your HCP about all the medicines you take, or body aches. including prescription and over-the-counter medicines,HBV reactivation. If you have ever had HBV infection,vitamins, and herbal supplements.it may become active again during or after treatment with KESIMPTA (reactivation). If this happens, it mayHow should I use KESIMPTA? cause serious liver problems including liver failure orSee the detailed Instructions for Use that comes with death. Before starting KESIMPTA, your HCP will do aKESIMPTA for information about how to prepare and blood test to check for HBV. They will also continueinject a dose of KESIMPTA and how to properly throw to monitor you during and after treatment withaway (dispose of) used KESIMPTA Sensoready pens KESIMPTA for HBV. Tell your HCP right away if you getor prefilled syringes.worsening tiredness or yellowing of your skin or the Use KESIMPTA exactly as your HCP tells you to white part of your eyes. use it.Progressive Multifocal Leukoencephalopathy (PML).Your HCP will show you how to prepare and inject PML may happen with KESIMPTA. PML is a rare,KESIMPTA the right way before you use it for the serious brain infection caused by a virus that may getfirst time.worse over days or weeks. PML can result in death or Do not inject into areas where the skin is tender, severe disability. Tell your HCP right away if you havebruised, red, scaly or hard. Avoid areas with moles, any new or worsening neurologic signs or symptoms.scars, or stretch marks. These may include weakness on one side of your body, loss of coordination in arms and legs, visionKESIMPTA may cause serious side effects including:problems, changes in thinking and memory, which Injection-related reactions. Injection-related may lead to confusion and personality changes.reactions are a common side effect of KESIMPTA.Weakened immune system. KESIMPTA taken beforeInjecting KESIMPTA can cause injection-related or after other medicines that weaken the immunereactions that can happen within 24 hours (1 day) system could increase your risk of getting infections. following the first injections and with later injections. Before you take KESIMPTA, tell your HCP about allTalk with your HCP if you have any of these signs and your medical conditions, including if you: symptoms: Have or think you have an infection including HBV at or near the injection site: redness of the skin, or PML. swelling, itching, and pain or Have ever taken, currently take, or plan to take that may happen when certain substances are medicines that affect your immune system. Thesereleased in your body: fever, headache, pain in medicines could increase your risk of gettingthe muscles, chills, and tiredness.an infection.Low immunoglobulins. KESIMPTA may cause aHave had a recent vaccination or are scheduled todecrease in some types of antibodies. Your HCP receive any vaccinations. will do blood tests to check your bloodYou should receive any required live or live- immunoglobulin levels.attenuated vaccines at least 4 weeks before youThe most common side effects of KESIMPTA include:start treatment with KESIMPTA. You should not Upper respiratory tract infection, with symptoms such receive live or live-attenuated vaccines whileas sore throat and runny nose, and headache.you are being treated with KESIMPTA and until Headache.your HCP tells you that your immune system is no longer weakened. You are encouraged to report negative side effectsWhenever possible, you should receive any non- of prescription drugs to the FDA. Visit www.fda.gov/live vaccines at least 2 weeks before you startmedwatch, or call 1-800-FDA-1088. treatment with KESIMPTA.Please see accompanying Consumer Brief SummaryTalk to your HCP about vaccinations foron the following page.your baby if you used KESIMPTA during your pregnancy.12060005_KSM_DTC_JLS_MS_Focus_M3FR.indd 1 12/13/23 11:26 AM'