b'Important Safety Information (cont)What is the most important information I should know(contraception) during treatment with KESIMPTA and about KESIMPTA? for 6 months after your last treatment. Talk with your KESIMPTA can cause serious side effects such as: HCP about what birth control method is right for you Infections. Serious infections, which can be life- during this time. threatening or cause death, can happen duringAre breastfeeding or plan to breastfeed. It is not treatment with KESIMPTA. If you have an activeknown if KESIMPTA passes into your breast milk.infection, your health care provider (HCP) should delayTalk to your HCP about the best way to feed your your treatment with KESIMPTA until your infection isbaby if you take KESIMPTA.gone. KESIMPTA taken before or after other medicinesTell your HCP about all the medicines you take, that weaken the immune system may increase yourincluding prescription and over-the-counter medicines, risk of getting infections. Tell your HCP right away ifvitamins, and herbal supplements.you have any infections or get any symptoms including painful and frequent urination, nasal congestion, runnyHow should I use KESIMPTA?nose, sore throat, fever, chills, cough, or body aches. See the detailed Instructions for Use that comes with HBV reactivation. If you have ever had HBV infection,KESIMPTA for information about how to prepare and it may become active again during or after treatmentinject a dose of KESIMPTA and how to properly throw with KESIMPTA (reactivation). If this happens, it mayaway (dispose of) used KESIMPTA Sensoready penscause serious liver problems including liver failure oror prefilled syringes.death. Before starting KESIMPTA, your HCP will do a blood test to check for HBV. They will also continueUse KESIMPTA exactly as your HCP tells you toto monitor you during and after treatment withuse it. KESIMPTA for HBV. Tell your HCP right away if you Your HCP will show you how to prepare and injectget worsening tiredness or yellowing of your skin orKESIMPTA the right way before you use it for thethe white part of your eyes. first time.Progressive Multifocal Leukoencephalopathy (PML).Do not inject into areas where the skin is tender, PML may happen with KESIMPTA. PML is a rare,bruised, red, scaly or hard. Avoid areas with moles, serious brain infection caused by a virus that may getscars, or stretch marks.worse over days or weeks. PML can result in death or severe disability. Tell your HCP right away if you haveKESIMPTA may cause serious side effects including:any new or worsening neurologic signs or symptoms.Injection-related reactions. Injection-related reactions These may include weakness on one side of yourare a common side effect of KESIMPTA. Injecting body, loss of coordination in arms and legs, visionKESIMPTA can cause injection-related reactions that problems, changes in thinking and memory, whichcan happen within 24 hours (1 day) following the first may lead to confusion and personality changes.injections and with later injections. There are two kinds Weakened immune system. KESIMPTA taken beforeof reactions:at or near the injection site: redness of the skin, or after other medicines that weaken the immune system could increase your risk of getting infections. swelling, itching, and pain. Talk to your HCP if you Before you take KESIMPTA, tell your HCP about allhave any of these signs and symptoms. your medical conditions, including if you: that may happen when certain substances areHave or think you have an infection including HBV released in your body: fever, headache, pain in or PML. the muscles, chills, tiredness, rash, hives, trouble Have ever taken, currently take, or plan to takebreathing, swelling of the face, eyelids, lips, mouth, medicines that affect your immune system. Thesetongue and throat, and feeling faint, or chest medicines could increase your risk of getting tightness. Contact your HCP right away if you an infection. experience any of these signs and symptoms, Have had a recent vaccination or are scheduled toespecially if they become worse or you have receive any vaccinations. new severe signs of reactions after subsequent injections. It could be a sign of an allergic You should receive any required live or live- reaction, which can be serious. attenuated vaccines at least 4 weeks before youLow immunoglobulins. KESIMPTA may cause a start treatment with KESIMPTA. You should notdecrease in some types of antibodies. Your HCPreceive live or live-attenuated vaccines whilewill do blood tests to check your blood you are being treated with KESIMPTA and untilimmunoglobulin levels.your HCP tells you that your immune system is no longer weakened. The most common side effects of KESIMPTA include:Upper respiratory tract infection, with symptoms such Whenever possible, you should receive any non-live vaccines at least 2 weeks before you startas sore throat and runny nose, and headache.treatment with KESIMPTA.Headache.Talk to your HCP about vaccinations for You are encouraged to report negative side effectsyour baby if you used KESIMPTA during yourof prescription drugs to the FDA. Visit www.fda.gov/pregnancy. medwatch, or call 1-800-FDA-1088. Are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known ifPlease see accompanying Consumer Brief Summary KESIMPTA will harm your unborn baby. Femaleson the following page. who can become pregnant should use birth control'