MEDICATION GUIDE. (fingolimod) capsules
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1 MEDICATION GUIDE GILENYA (je-len-yah) (finglimd) capsules Read this Medicatin Guide befre yu start using GILENYA 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 health prblem r treatment. What is the mst imprtant infrmatin I shuld knw abut GILENYA? GILENYA may cause serius side effects, including: 1. Slw heart rate (bradycardia r bradyarrhythmia) when yu start taking GILENYA. GILENYA can cause yur heart rate t slw dwn, especially after yu take yur first dse. Yu will have a test t check the electrical activity f yur heart (ECG) befre yu take yur first dse f GILENYA. Yu will be bserved by a healthcare prfessinal fr at least 6 hurs after yu take yur first dse f GILENYA. After yu take yur first dse f GILENYA: Yur pulse and bld pressure shuld be checked every hur. Yu shuld be bserved by a healthcare prfessinal t see if yu have any serius side effects. If yur heart rate slws dwn t much, yu may have symptms such as: dizziness tiredness feeling like yur heart is beating slwly r skipping beats If yu have any f the symptms f slw heart rate, they will usually happen during the first 6 hurs after yur first dse f GILENYA. Symptms can happen up t 24 hurs after yu take yur first GILENYA dse. 6 hurs after yu take yur first dse f GILENYA yu will have anther ECG. If yur ECG shws any heart prblems r if yur heart rate is still t lw r cntinues t decrease, yu will cntinue t be bserved. If yu have any serius side effects after yur first dse f GILENYA, especially thse that require treatment with ther medicines, yu will stay in the medical facility t be bserved vernight. Yu will als be bserved fr any serius side effects fr at least 6 hurs after yu take yur secnd dse f GILENYA the next day. If yu have certain types f heart prblems, r if yu are taking certain types f medicines that can affect yur heart, yu will be bserved vernight after yu take yur first dse f GILENYA. Yur slw heart rate will usually return t nrmal within 1 mnth after yu start taking GILENYA. Call yur dctr r g t the nearest hspital emergency rm right away if yu have any symptms f a slw heart rate. If yu miss 1 r mre dses f GILENYA yu may need t be bserved by a healthcare prfessinal when yu take yur next dse. Call yur dctr if yu miss a dse f GILENYA. See Hw shuld I take GILENYA?
2 2. Infectins. GILENYA can increase yur risk f serius infectins and decrease the way vaccines wrk in yur bdy t prevent certain diseases, especially the chicken px vaccine. GILENYA lwers the number f white bld cells (lymphcytes) in yur bld. This will usually g back t nrmal within 2 mnths f stpping treatment. Yur dctr may d a bld test befre yu start taking GILENYA. Call yur dctr right away if yu have any f these symptms f an infectin: fever tiredness bdy aches chills nausea vmiting headache accmpanied by fever, neck stiffness, sensitivity t light, nausea, and/r cnfusin (these may be symptms f meningitis) 3. Prgressive multifcal leukencephalpathy (PML). PML is a rare brain infectin that usually leads t death r severe disability. If PML happens, it usually happens in peple with weakened immune systems. It is imprtant that yu call yur dctr right away if yu have any new r wrsening medical prblems that have lasted several days, including prblems with: thinking eyesight strength balance weakness n 1 side f yur bdy using yur arms and legs 4. A prblem with yur visin called macular edema. Macular edema can cause sme f the same visin symptms as an MS attack (ptic neuritis). Yu may nt ntice any symptms with macular edema. If macular edema happens, it usually starts in the first 3 t 4 mnths after yu start taking GILENYA. Yur dctr shuld test yur visin befre yu start taking GILENYA and 3 t 4 mnths after yu start taking GILENYA, r any time yu ntice visin changes during treatment with GILENYA. Yur risk f macular edema may be higher if yu have diabetes r have had an inflammatin f yur eye called uveitis. Call yur dctr right away if yu have any f the fllwing: What is GILENYA? blurriness r shadws in the center f yur visin a blind spt in the center f yur visin sensitivity t light unusually clred (tinted) visin GILENYA is a prescriptin medicine used t treat relapsing frms f multiple sclersis (MS) in adults. GILENYA can decrease the number f MS flare-ups (relapses). GILENYA des nt cure MS, but it can help slw dwn the physical prblems that MS causes. It is nt knwn if GILENYA is safe and effective in children under 18 years f age.
3 Wh shuld nt take GILENYA? D nt take GILENYA if yu: have had a heart attack, unstable angina, strke r warning strke r certain types f heart failure in the last 6 mnths have certain types f irregular r abnrmal heartbeat (arrhythmia), including patients in whm a heart finding called prlnged QT is seen n ECG befre starting GILENYA are taking certain medicines that change yur heart rhythm are allergic (hypersensitive) t finglimd r any f the ther ingredients f GILENYA listed at the end f this medicatin guide. Allergic reactins, which culd include symptms f rash r itchy hives, swelling f lips, tngue r face, are mre likely t ccur n the day yu start GILENYA treatment but may ccur later. If yu think yu may be allergic, ask yur dctr fr advice. If any f the abve situatins apply t yu, tell yur dctr. What shuld I tell my dctr befre taking GILENYA? Befre yu take GILENYA, tell yur dctr abut all yur medical cnditins, including if yu had r nw have: an irregular r abnrmal heartbeat (arrhythmia) a histry f strke r warning strke heart prblems, including heart attack r angina a histry f repeated fainting (syncpe) a fever r infectin, r yu are unable t fight infectins due t a disease r taking medicines that lwer yur immune system. Tell yur dctr if yu have had chicken px r have received the vaccine fr chicken px. Yur dctr may d a bld test fr chicken px virus. Yu may need t get the full curse f the vaccine fr chicken px and then wait 1 mnth befre yu start taking GILENYA. eye prblems, especially an inflammatin f the eye called uveitis. diabetes breathing prblems, including during yur sleep liver prblems high bld pressure skin cancers such as basal cell carcinma (BCC) and melanma Are pregnant r plan t becme pregnant. GILENYA may harm yur unbrn baby. Talk t yur dctr if yu are pregnant r are planning t becme pregnant. Tell yur dctr right away if yu becme pregnant while taking GILENYA r if yu becme pregnant within 2 mnths after yu stp taking GILENYA. If yu are a female wh can becme pregnant, yu shuld use effective birth cntrl during yur treatment with GILENYA and fr at least 2 mnths after yu stp taking GILENYA. Pregnancy Registry: There is a registry fr wmen wh becme pregnant during treatment with GILENYA. If yu becme pregnant while taking GILENYA, talk t yur dctr abut registering with the GILENYA Pregnancy
4 Registry. The purpse f this registry is t cllect infrmatin abut yur health and yur baby s health. Fr mre infrmatin, cntact the GILENYA Pregnancy Registry by calling Quintiles at , by sending an t gpr@quintiles.cm, r g t Are breastfeeding r plan t breastfeed. It is nt knwn if GILENYA passes int yur breast milk. Yu and yur dctr shuld decide if yu will take GILENYA r breastfeed. Yu shuld nt d bth. Tell yur dctr abut all the medicines yu take r have recently taken, including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. Especially tell yur dctr if yu take medicines that affect yur immune system, including crticsterids, r have taken them in the past. Knw the medicines yu take. Keep a list f yur medicines with yu t shw yur dctr and pharmacist when yu get a new medicine. Using GILENYA and ther medicines tgether may affect each ther causing serius side effects. Especially tell yur dctr if yu take vaccines. Tell yur dctr if yu have been vaccinated within 1 mnth befre yu start taking GILENYA. Yu shuld nt get certain vaccines, called live attenuated vaccines, while yu take GILENYA and fr at least 2 mnths after yu stp taking GILENYA. If yu take certain vaccines, yu may get the infectin the vaccine shuld have prevented. Vaccines may nt wrk as well when given during GILENYA treatment. Hw shuld I take GILENYA? Yu will be bserved by a healthcare prfessinal fr at least 6 hurs after yur first dse f GILENYA. See What is the mst imprtant infrmatin I shuld knw abut GILENYA? Take GILENYA exactly as yur dctr tells yu t take it. Take GILENYA 1 time each day. If yu take t much GILENYA, call yur dctr r g t the nearest hspital emergency rm right away. Take GILENYA with r withut fd. D nt stp taking GILENYA withut talking with yur dctr first. Call yur dctr right away if yu miss a dse f GILENYA. Yu may need t be bserved by a healthcare prfessinal fr at least 6 hurs when yu take yur next dse. If yu need t be bserved by a healthcare prfessinal when yu take yur next dse f GILENYA yu will have: an ECG befre yu take yur dse hurly pulse and bld pressure measurements after yu take the dse an ECG 6 hurs after yur dse If yu have certain types f heart prblems, r if yu are taking certain types f medicines that can affect yur heart, yu will be bserved vernight by a healthcare prfessinal in a medical facility after yu take yur dse f GILENYA.
5 If yu have serius side effects after taking a dse f GILENYA, especially thse that require treatment with ther medicines, yu will stay in the medical facility t be bserved vernight. If yu were bserved vernight, yu will als be bserved fr any serius side effects fr at least 6 hurs after yu take yur secnd dse f GILENYA. See What is the mst imprtant infrmatin I shuld knw abut GILENYA? What are pssible side effects f GILENYA? GILENYA can cause serius side effects. See What is the mst imprtant infrmatin I shuld knw abut GILENYA? Serius side effects include: swelling and narrwing f the bld vessels in yur brain. A cnditin called PRES (Psterir reversible encephalpathy syndrme) has ccurred rarely in patients taking GILENYA. Symptms f PRES usually get better when yu stp taking GILENYA. Hwever, if left untreated it may lead t a strke. Call yur dctr right away if yu have any f the fllwing symptms: sudden headache cnfusin seizures lss f visin weakness breathing prblems. Sme peple wh take GILENYA have shrtness f breath. Call yur dctr right away if yu have truble breathing. liver prblems. GILENYA may cause liver prblems. Yur dctr shuld d bld tests t check yur liver befre yu start taking GILENYA. 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 skin cancers including basal cell carcinma (BCC) and melanma. Talk t yur dctr if yu ntice any skin ndules (e.g., shiny pearly ndules), patches r pen sres that d nt heal within weeks, r unusual mles, which may present as a change in clr, shape, r size ver time. These may be signs f skin cancer. The mst cmmn side effects f GILENYA include: headache abnrmal liver tests diarrhea cugh flu sinusitis
6 back pain abdminal pain pain in arms r legs Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. These are nt all f the pssible side effects f GILENYA. 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 FDA Hw d I stre GILENYA? Stre GILENYA in the riginal bttle r blister pack in a dry place. Stre GILENYA at rm temperature between 59 F t 86 F (15 C t 30 C). Keep GILENYA and all medicines ut f the reach f children. General infrmatin abut GILENYA Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use GILENYA fr a cnditin fr which it was nt prescribed. D nt give GILENYA 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 GILENYA. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur dctr r pharmacist fr infrmatin abut GILENYA that is written fr healthcare prfessinals. Fr mre infrmatin, g t r call What are the ingredients in GILENYA? Active ingredient: finglimd Inactive ingredients: gelatin, magnesium stearate, mannitl, titanium dixide, yellw irn xide. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. GILENYA is a registered trademark f Nvartis AG. Manufactured by: Nvartis Pharma Stein AG Stein, Switzerland Distributed by: Nvartis Pharmaceuticals Crpratin East Hanver, New Jersey Nvartis T Revised: 12/2017
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