b'o If you miss a dose, take it as soon as you rememberecreased strengthd on the same day. If the whole day passes before youroblems with balancepremember, take your missed dose the next day.M c Do not take 2 doses at the same time. Instead,hanges in your visionc m you will extend the number of days in thatchanges in your thinking or memoryt treatment week. confusionYour healthcare provider will continue to monitor your changes in your personalitya health during the 2 yearly treatment courses, and forat least another 2 years during which you do not need o liver problems. MAVENCLAD may cause liver problems.a ato take MAVENCLAD. It is not known if MAVENCLAD is Your healthcare provider should do blood tests to safe and e\x1eective in people who restart MAVENCLAD check your liver before you start taking MAVENCLAD.M k treatment more than 2 years after completing 2 yearly Call your healthcare provider right away if you havec treatment courses.any of the following symptoms of liver problems:r What are the possible side e\x1eects of MAVENCLAD?nauseaY h MAVENCLAD can cause serious side e\x1eects, including: vomitingi hSee What is the most important information stomach painoa I should know about MAVENCLAD? tirednessa o low blood cell counts. Low blood cell counts haveloss of appetitet happened and can increase your risk of infectionsm during your treatment with MAVENCLAD. Youryour skin or the whites of your eyes turn yellowhealthcare provider will do blood tests before dark urineyou start treatment with MAVENCLAD, duringo allergic reactions (hypersensitivities). MAVENCLADyour treatment with MAVENCLAD, and afterward,as needed. can cause serious allergic reactions. Stop yourt o serious infections such as: treatment with MAVENCLAD and go to the closest emergency room for medical help right away if youh TB, hepatitis B or C, and shingles (herpes zoster). have any signs or symptoms of allergic reactions.Y Fatal cases of TB and hepatitis have happened Symptoms of an allergic reaction may include: skinp h with cladribine during clinical studies. Tell your rash, swelling or itching of the face, lips, tongue or h healthcare provider right away if you get any throat, or trouble breathing.M a symptoms of the following infection related problemsp o or if any of the symptoms get worse, including: heart failure. MAVENCLAD may cause heart failure,ow ifever which means your heart may not pump as well asit should. Call your healthcare provider or go to theU haching painful muscles closest emergency room for medical help right awaydrif you have any signs or symptoms such as shortnessl headache of breath, a fast or irregular heart beat, or unusualt ofeeling of being generally unwell swelling in your body. Your healthcare provider maypT oss of appetite delay or completely stop treatment with MAVENCLADs l if you have severe side e\x1eects.c y burning, tingling, numbness or itchiness of the The most common side e\x1eects of MAVENCLAD include:h skin in the a\x1eected areao sskin blotches, blistered rash and severe pain o upper respiratory infectionfh progressive multifocal leukoencephalopathy (PML). o headacheyF a PML is a rare brain infection that usually leads to o low white blood cell countsk death or severe disability. Although PML has not These are not all the possible side e\x1eects of MAVENCLAD.b D been seen in MS patients taking MAVENCLAD, it mayhappen in people with weakened immune systems. Call your doctor for medical advice about side e\x1eects.U M Symptoms of PML get worse over days to weeks. You may report side e\x1eects to FDA at 1-800-FDA-1088.t S Call your healthcare provider right away if you have Distributed by: EMD Serono, Inc., Rockland, MA 02370f any new or worsening neurologic signs or symptomsy y of PML, that have lasted several days, including: MAVENCLAD is a registered trademark of Merck KGaA,Darmstadt, Germany.For more information, call toll-free 1-877-447-3243 weakness on 1 side of your bodyoss of coordination in your arms and legs or go to www.mavenclad.comr lr Lp np Mh rt Tmw M 2019 EMD Serono, Inc.All rights reserved.US/CLA/0619/0371Printed in USA07/19'