Medication Guide. AUBAGIO (oh-bah-gee-oh) (teriflunomide) tablets

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1 Medicatin Guide AUBAGIO (h-bah-gee-h) (teriflunmide) tablets Read this Medicatin Guide befre yu start using AUBAGIO and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking with yur dctr abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut AUBAGIO? AUBAGIO may cause serius side effects, including: Liver prblems: AUBAGIO may cause serius liver prblems that may lead t death. Yur risk f liver prblems may be higher if yu take ther medicines that als affect yur liver. Yur dctr shuld d bld tests t check yur liver: within 6 mnths befre yu start taking AUBAGIO 1 time a mnth fr 6 mnths after yu start taking AUBAGIO Call yur dctr right away if yu have any f the fllwing symptms f liver prblems: nausea vmiting stmach pain lss f appetite tiredness yur skin r the whites f yur eyes turn yellw dark urine Harm t yur unbrn baby: AUBAGIO may cause harm t yur unbrn baby. D nt take AUBAGIO if yu are pregnant. D nt take AUBAGIO unless yu are using effective birth cntrl. If yu are a female, yu shuld have a pregnancy test befre yu start taking AUBAGIO. Use effective birth cntrl during yur treatment with AUBAGIO. After stpping AUBAGIO, cntinue using effective birth cntrl until yu have bld tests t make sure yur bld levels f AUBAGIO are lw enugh. If yu becme pregnant while taking AUBAGIO r within 2 years after yu stp taking it, tell yur dctr right away. AUBAGIO Pregnancy Registry. If yu becme pregnant while taking AUBAGIO r during the 2 years after yu stp taking AUBAGIO, talk t yur dctr abut enrlling in the AUBAGIO Pregnancy Registry at , ptin 2. The purpse f this registry is t cllect infrmatin abut yur health and yur baby s health. Fr men taking AUBAGIO:

2 If yur female partner plans t becme pregnant, yu shuld stp taking AUBAGIO and ask yur dctr hw t quickly lwer the levels f AUBAGIO in yur bld. If yur female partner des nt plan t becme pregnant, yu and yur female partner shuld use effective birth cntrl during yur treatment with AUBAGIO. AUBAGIO remains in yur bld after yu stp taking it, s cntinue using effective birth cntrl until AUBAGIO bld levels have been checked and they are lw enugh. AUBAGIO may stay in yur bld fr up t 2 years after yu stp taking it. Yur dctr can prescribe a medicine t help lwer yur bld levels f AUBAGIO mre quickly. Talk t yur dctr if yu want mre infrmatin abut this. What is AUBAGIO? AUBAGIO is a prescriptin medicine used t treat relapsing frms f multiple sclersis (MS). AUBAGIO can decrease the number f MS flare-ups (relapses). AUBAGIO des nt cure MS, but it can help slw dwn the physical prblems that MS causes. It is nt knwn if AUBAGIO is safe and effective in children. Wh shuld nt take AUBAGIO? D nt take AUBAGIO if yu: have severe liver prblems are pregnant r are f childbearing age and nt using effective birth cntrl take a medicine called leflunmide What shuld I tell my dctr befre taking AUBAGIO? Befre yu take AUBAGIO, tell yur dctr if yu: have liver r kidney prblems have a fever r infectin, r yu are unable t fight infectins have numbness r tingling in yur hands r feet that is different frm yur MS symptms have diabetes have had serius skin prblems when taking ther medicines have breathing prblems have high bld pressure are breastfeeding r plan t breastfeed. It is nt knwn if AUBAGIO passes int yur breast milk. Yu and yur dctr shuld decide if yu will take AUBAGIO r breastfeed. Yu shuld nt d bth at the same time. Tell yur dctr abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements.

3 Using AUBAGIO and ther medicines may affect each ther causing serius side effects. AUBAGIO may affect the way ther medicines wrk, and ther medicines may affect hw AUBAGIO wrks. Especially tell yur dctr if yu take medicines that culd raise yur chance f getting infectins, including medicines used t treat cancer r t cntrl yur immune system. Ask yur dctr r pharmacist fr a list f these medicines if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw yur dctr r pharmacist when yu get a new medicine. Hw shuld I take AUBAGIO? Take AUBAGIO exactly as yur dctr tells yu t take it. Take AUBAGIO 1 time each day. Take AUBAGIO with r withut fd. What are pssible side effects f AUBAGIO? AUBAGIO may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut AUBAGIO? decreases in yur white bld cell cunt. Yur white bld cell cunts shuld be checked befre yu start taking AUBAGIO. When yu have a lw white bld cell cunt yu: may have mre frequent infectins. Yu shuld have a skin test fr TB (Tuberculsis) befre yu start taking AUBAGIO. Tell yur dctr if yu have any f these symptms f an infectin: fever tiredness bdy aches chills nausea vmiting

4 shuld nt receive certain vaccinatins during yur treatment with AUBAGIO and fr 6 mnths after yur treatment with AUBAGIO ends. numbness r tingling in yur hands r feet that is different frm yur MS symptms. Yu have a greater chance f getting peripheral neurpathy if yu: are ver 60 years f age take certain medicines that affect yur nervus system have diabetes Tell yur dctr if yu have numbness r tingling in yur hands r feet that is different frm yur MS. kidney prblems. Tell yur dctr if yu have pain in yur side (flank pain). high ptassium levels in yur bld. Tell yur dctr if yu have nausea that des nt g away r a racing heartbeat. serius skin prblems. Tell yur dctr if yu have any skin prblems such as redness and peeling. new r wrsening breathing prblems. Tell yur dctr if yu have shrtness f breath r cughing with r withut fever. high bld pressure. Yur dctr shuld check yur bld pressure befre yu start taking AUBAGIO and while yu are taking AUBAGIO. The mst cmmn side effects f AUBAGIO include: increases in the results f bld tests t check yur liver hair thinning r lss (alpecia) diarrhea flu nausea burning r prickling feeling in yur skin (paraesthesia) Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f AUBAGIO. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at Hw shuld I stre AUBAGIO? Stre AUBAGIO at rm temperature between 68 F t 77 F (20 C t 25 C). Keep AUBAGIO and all medicines ut f reach f children.

5 General infrmatin abut the safe and effective use f AUBAGIO. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use AUBAGIO fr a cnditin fr which it was nt prescribed. D nt give AUBAGIO t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut AUBAGIO. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut AUBAGIO that is written fr healthcare prfessinals. Fr mre infrmatin, g t r call Genzyme Medical Infrmatin Services at , ptin 2. What are the ingredients in AUBAGIO? Active ingredient: teriflunmide Inactive ingredients: lactse mnhydrate, crn starch, hydrxyprpylcellulse, micrcrystalline cellulse, sdium starch glyclate, magnesium stearate, hyprmellse, titanium dixide, talc, plyethylene glycl and indig carmine aluminum lake. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Genzyme Crpratin 500 Kendall Street Cambridge, MA A Sanfi Cmpany September 2012

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