b'IMPORTANT INFORMATION ABOUT MAVENCLAD (cladribine) tablets, for oral use o Read this information carefully before usingIt is not known if MAVENCLAD is safe and e\x1eective in MAVENCLAD and each time you get a rell, as therechildren under 18 years of age. may be new information. This information does not takeDo not take MAVENCLAD if you: y the place of talking with your healthcare provider (HCP). t What is the most important information I should knowohave cancer (malignancy).about MAVENCLAD? o are pregnant, plan to become pregnant, or areMAVENCLAD can cause serious side e\x1fects, including: a woman of childbearing age or a man able to fathera child and you are not using birth control. Seeo Risk of cancer (malignancies). Treatment withWhat is the most important information I should MAVENCLAD may increase your risk of developingknow about MAVENCLAD?cancer. Talk to your healthcare provider about your risk of developing cancer if you receive MAVENCLAD.oare human immunodeciency virus (HIV) positive. You should follow your healthcare providerohave active infections, including tuberculosis (TB),instructions about screening for cancer. hepatitis B or C. o MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant wheno are allergic to cladribine. they start treatment with MAVENCLAD or becomeoare breastfeeding. See Before you take MAVENCLAD,pregnant during MAVENCLAD dosing and within tell your healthcare provider about all of your 6 months after the last dose of each yearlymedical conditions, including if you:treatment course. Stop your treatment withBefore you take MAVENCLAD, tell your healthcare MAVENCLAD and call your healthcare providerprovider about all of your medical conditions,right away if you become pregnant duringincluding if you: treatment with MAVENCLAD.For females who are able to become pregnant: o think you have an infection.ohave heart failure.Your healthcare provider should order a pregnancy test for you before you begin yourohave liver or kidney problems.rst and second yearly treatment course ofo have taken, take, or plan to take medicines that MAVENCLAD to make sure that you are nota\x1eect your immune system or your blood cells, orpregnant. Your healthcare provider will decideother treatments for MS. Certain medicines can when to do the test. increase your risk of getting an infection.Use e\x1eective birth control (contraception) on the days on which you take MAVENCLAD and for atohave had a recent vaccination or are scheduled toleast 6 months after the last dose of each yearlyreceive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks treatment course. preceding your treatment with MAVENCLAD. YouT alk to your healthcare provider if you use oralshould not receive these types of vaccines duringcontraceptives (the pill). your treatment with MAVENCLAD and until your You should use a second method of birth controlhealthcare provider tells you that your immuneson the days on which you take MAVENCLAD andsystem is no longer weakened.for at least 4 weeks after your last dose of eachohave or have had cancer. yearly treatment course. o are breastfeeding or plan to breastfeed. It is notFor males with female partners who are able toknown if MAVENCLAD passes into your breast milk. become pregnant: Do not breastfeed on the days on which you takeUse e\x1eective birth control (contraception) duringMAVENCLAD, and for 10 days after the last dose. the days on which you take MAVENCLAD andSee Do not take MAVENCLAD if you: Cfor at least 6 months after the last dose of eachTell your healthcare provider about all the medicines yearly treatment course. you take, including prescription and over-the-counter What is MAVENCLAD? medicines, vitamins, and herbal supplements.MAVENCLAD is a prescription medicine used to treatHow should I take MAVENCLAD? orelapsing forms of multiple sclerosis (MS), to include relapsing remitting disease and active secondaryo Limit contact with your skin. Avoid touching your progressive disease, in adults. Because of its safetynose, eyes and other parts of the body. If you get prole, MAVENCLAD is generally used in people whoMAVENCLAD on your skin or on any surface, wash it have tried another MS medicine that they could notright away with water.tolerate or that has not worked well enough. oT ake MAVENCLAD at least 3 hours apart from other MAVENCLAD is not recommended for use in people medicines taken by mouth during the 4- to 5-day with clinically isolated syndrome (CIS). MAVENCLAD treatment week.'