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, which can be life- who can become pregnant should use birth control threatening or cause death, can happen during(contraception) during treatment with KESIMPTA and treatment with KESIMPTA. If you have an activefor 6 months after your last treatment. Talk with your infection, your health care provider (HCP) should delayHCP about what birth control method is right for you your treatment with KESIMPTA until your infection isduring this time. gone. KESIMPTA taken before or after other medicines Are breastfeeding or plan to breastfeed. It is not that weaken the immune system may increase yourknown if KESIMPTA passes into your breast milk. risk of getting infections. Tell your HCP right awayTalk to your HCP about the best way to feed your if you have any infections or get any symptomsbaby if you take KESIMPTA.including painful and frequent urination, nasalTell your HCP about all the medicines you take, congestion, runny nose, sore throat, fever, chills, cough,including prescription and over-the-counter medicines, or body aches. vitamins, and herbal supplements. HBV reactivation. If you have ever had HBV infection, it may become active again during or after treatmentHow should I use KESIMPTA? with KESIMPTA (reactivation). If this happens, it maySee the detailed Instructions for Use that comes with cause serious liver problems including liver failure orKESIMPTA for information about how to prepare and death. Before starting KESIMPTA, your HCP will do ainject a dose of KESIMPTA and how to properly throw blood test to check for HBV. They will also continueaway (dispose of) used KESIMPTA Sensoready pens to monitor you during and after treatment withor prefilled syringes.KESIMPTA for HBV. Tell your HCP right away if you get Use KESIMPTA exactly as your HCP tells you to worsening tiredness or yellowing of your skin or theuse it. white part of your eyes.Your HCP will show you how to prepare and injectProgressive Multifocal Leukoencephalopathy (PML). KESIMPTA the right way before you use it for the PML may happen with KESIMPTA. PML is a rare,first time.serious brain infection caused by a virus that may get Do not inject into areas where the skin is tender, worse over days or weeks. PML can result in death orbruised, red, scaly or hard. Avoid areas with moles, severe disability. Tell your HCP right away if you havescars, or stretch marks.any new or worsening neurologic signs or symptoms. These may include weakness on one side of yourKESIMPTA may cause serious side effects including:body, loss of coordination in arms and legs, vision Injection-related reactions. Injection-related problems, changes in thinking and memory, whichreactions are a common side effect of KESIMPTA. may lead to confusion and personality changes.Injecting KESIMPTA can cause injection-relatedWeakened immune system. KESIMPTA taken beforereactions that can happen within 24 hours (1 day) or after other medicines that weaken the immunefollowing the first injections and with later injections. system could increase your risk of getting infections. Talk with your HCP if you have any of these signs and Before you take KESIMPTA, tell your HCP about allsymptoms:your medical conditions, including if you:at or near the injection site: redness of the skin, swelling, itching, and pain or Have or think you have an infection including HBV that may happen when certain substances are or PML. released in your body: fever, headache, pain inHave ever taken, currently take, or plan to takethe muscles, chills, and tiredness.medicines that affect your immune system. These Low immunoglobulins. KESIMPTA may cause a medicines could increase your risk of gettingdecrease in some types of antibodies. Your HCP an infection. will do blood tests to check your bloodHave had a recent vaccination or are scheduled toimmunoglobulin levels.receive any vaccinations. The most common side effects of KESIMPTA include: You should receive any required live or live-attenuated vaccines at least 4 weeks before you Upper respiratory tract infection, with symptoms such start treatment with KESIMPTA. You should notas sore throat and runny nose, and headache.receive live or live-attenuated vaccines while Headache.you are being treated with KESIMPTA and untilYou are encouraged to report negative side effects your HCP tells you that your immune system is noof prescription drugs to the FDA. Visit www.fda.gov/longer weakened. medwatch, or call 1-800-FDA-1088.Whenever possible, you should receive any non-live vaccines at least 2 weeks before you startPlease see accompanying Consumer Brief Summary treatment with KESIMPTA.on the following page. Talk to your HCP about vaccinations for your baby if you used KESIMPTA during your pregnancy.12095632_KSM_DTC_JLS_MS_Focus_M3FR.indd 1 2/22/24 3:14 PM'