b'Important Safety Information (cont)What is the most important information I should knowlast treatment. Talk with your HCP about what birth about KESIMPTA? control method is right for you during this time. KESIMPTA can cause serious side effects such as:Are breastfeeding or plan to breastfeed. It is not knownInfections. Serious infections, which can beif KESIMPTA passes into your breast milk. Talk to your life-threatening or cause death, can happen duringHCP about the best way to feed your baby if you take treatment with KESIMPTA. If you have an activeKESIMPTA.infection, your health care provider (HCP) should delayTell your HCP about all the medicines you take, your treatment with KESIMPTA until your infection isincluding prescription and over-the-counter medicines, gone. KESIMPTA taken before or after other medicinesvitamins, and herbal supplements.that weaken the immune system may increase your risk of getting infections. Tell your HCP right away ifHow should I use KESIMPTA? you have any infections or get any symptoms includingSee the detailed Instructions for Use that comes with painful and frequent urination, nasal congestion, runnyKESIMPTA for information about how to prepare and nose, sore throat, fever, chills, cough, or body aches. inject a dose of KESIMPTA and how to properly throwHBV reactivation. If you have ever had HBV infection,away (dispose of) used KESIMPTA Sensoready pens it may become active again during or after treatmentor prefilled syringes.with KESIMPTA (reactivation). If this happens, it may Use KESIMPTA exactly as your HCP tells you to cause serious liver problems including liver failure oruse it. death. Before starting KESIMPTA, your HCP will do a Your HCP will show you how to prepare and inject blood test to check for HBV. They will also continue toKESIMPTA the right way before you use it for the monitor you during and after treatment with KESIMPTAfirst time.for HBV. Tell your HCP right away if you get worsening Do not inject into areas where the skin is tender, bruised, tiredness or yellowing of your skin or the white part ofred, scaly or hard. Avoid areas with moles, scars, or your eyes. stretch marks.Progressive Multifocal Leukoencephalopathy (PML).PML may happen with KESIMPTA. PML is a rare, seriousKESIMPTA may cause serious side effects including:brain infection caused by a virus that may get worse Injection-related reactions. Injection-related reactions over days or weeks. PML can result in death or severeare a common side effect of KESIMPTA. Injecting disability. Tell your HCP right away if you have anyKESIMPTA can cause injection-related reactions that new or worsening neurologic signs or symptoms. Thesecan happen within 24 hours (1 day) following the first may include weakness on one side of your body, loss ofinjections and with later injections. There are two kinds coordination in arms and legs, vision problems, changesof reactions:in thinking and memory, which may lead to confusion at or near the injection site: redness of the skin, and personality changes.swelling, itching, and pain. Talk to your HCP if youWeakened immune system. KESIMPTA taken before orhave any of these signs and symptoms.after other medicines that weaken the immune system that may happen when certain substances are could increase your risk of getting infections. released in your body: fever, headache, pain in Before you take KESIMPTA, tell your HCP about all yourthe muscles, chills, tiredness, rash, hives, trouble medical conditions, including if you: breathing, swelling of the face, eyelids, lips, mouth,Have or think you have an infection including HBVtongue and throat, and feeling faint, or chest or PML. tightness. Contact your HCP right away if youHave ever taken, currently take, or plan to takeexperience any of these signs and symptoms, medicines that affect your immune system. Theseespecially if they become worse or you have medicines could increase your risk of gettingnew severe signs of reactions after subsequent an infection. injections. It could be a sign of an allergic reaction,Have had a recent vaccination or are scheduled towhich can be serious.receive any vaccinations.Low immunoglobulins. KESIMPTA may cause aYou should receive any required live or live- decrease in some types of antibodies. Your HCP attenuated vaccines at least 4 weeks before youwill do blood tests to check your blood immunoglobulin start treatment with KESIMPTA. You should notlevels.receive live or live-attenuated vaccines while youThe most common side effects of KESIMPTA include:are being treated with KESIMPTA and until your Upper respiratory tract infection, with symptoms such HCP tells you that your immune system is noas sore throat and runny nose, and headache.longer weakened. Whenever possible, you should receive any non-Headache.live vaccines at least 2 weeks before you startYou are encouraged to report negative side effects treatment with KESIMPTA.of prescription drugs to the FDA. Visit www.fda.gov/ Talk to your HCP about vaccinations for yourmedwatch, or call 1-800-FDA-1088. baby if you used KESIMPTA during your pregnancy. Are pregnant, think that you might be pregnant, orPlease see accompanying Consumer Brief Summary on plan to become pregnant. It is not known if KESIMPTAthe following page.will harm your unborn baby. Females who can become pregnant should use birth control (contraception) duringKESIMPTA, the KESIMPTA logo, and SENSOREADY are treatment with KESIMPTA and for 6 months after yourregistered trademarks of Novartis AG.'