Patient Information. (capecitabine) Tablets, Film Coated

Transcription

1 Patient Infrmatin XELODA (zeh-loe-duh) (capecitabine) Tablets, Film Cated What is the mst imprtant infrmatin I shuld knw abut XELODA? XELODA can cause serius side effects, including: XELODA can interact with bld thinner medicines, such as warfarin (COUMADIN ). Taking XELODA with these medicines can cause changes in hw fast yur bld clts, and can cause bleeding that can lead t death. This can happen as sn as a few days after yu start taking XELODA, r later during treatment, and pssibly even within 1 mnth after yu stp taking XELODA. Yur risk may be higher because yu have cancer, and if yu are ver 60 years f age. Befre taking XELODA, tell yur dctr if yu are taking warfarin (COUMADIN) r anther bld thinner medicine. If yu take warfarin (COUMADIN) r anther bld thinner that is like warfarin (COUMADIN) during treatment with XELODA, yur dctr shuld d bld tests ften, t check hw fast yur bld clts during and after yu stp treatment with XELODA. Yur dctr may change yur dse f the bld thinner medicine if needed. See What are the pssible side effects f XELODA? fr mre infrmatin abut side effects. What is XELODA? XELODA is a prescriptin medicine used t treat peple with: cancer f the cln that has spread t lymph ndes in the area clse t the cln (Dukes C stage), after they have surgery. cancer f the cln r rectum (clrectal) that has spread t ther parts f the bdy (metastatic). breast cancer that has spread t ther parts f the bdy (metastatic) tgether with anther medicine called dcetaxel after treatment with certain ther anticancer medicines have nt wrked. breast cancer that has spread t ther parts f the bdy and has nt imprved after treatment with paclitaxel and certain ther anti-cancer medicines, r wh cannt receive any mre treatment with certain anti-cancer medicines. It is nt knwn if XELODA is safe and effective in children. 41

2 Wh shuld nt take XELODA? D nt take XELODA if yu: have been tld that yu lack the enzyme DPD (dihydrpyrimidine dehydrgenase). have severe kidney prblems. are allergic t capecitabine, 5-flururacil, r any f the ingredients in XELODA. See the end f this leaflet fr a cmplete list f ingredients in XELODA. Talk t yur dctr befre taking XELODA if yu are nt sure if yu have any f the cnditins listed abve. What shuld I tell my dctr befre taking XELODA? See What is the mst imprtant infrmatin I shuld knw abut XELODA?. Befre yu take XELODA, tell yur dctr if yu: have had heart prblems. have kidney r liver prblems. have any ther medical cnditins. are pregnant r plan t becme pregnant. XELODA can harm yur unbrn baby. Yu shuld nt becme pregnant during treatment with XELODA. Talk t yur dctr abut birth cntrl chices that may be right fr yu during treatment with XELODA. are breastfeeding r plan t breastfeed. It is nt knwn if XELODA passes int yur breast milk. Yu and yur dctr shuld decide if yu will take XELODA r breastfeed. Yu shuld nt d bth. Tell yur dctr abut all the medicines yu take, including prescriptin and verthe-cunter medicines, vitamins, and herbal supplements. XELODA may affect the way ther medicines wrk, and ther medicines may affect the way XELODA wrks. Knw the medicines yu take. Keep a list f them t shw yur dctr and pharmacist when yu get a new medicine. Hw shuld I take XELODA? Take XELODA exactly as yur dctr tells yu t take it. Yur dctr will tell yu hw much XELODA t take and when t take it. Take XELODA 2 times a day, 1 time in the mrning and 1 time in the evening. Take XELODA within 30 minutes after finishing a meal. Swallw XELODA tablets whle with water. D nt crush r cut XELODA tablets. 42

3 Ask yur healthcare prvider r pharmacist hw t safely thrw away any unused XELODA. If yu have side effects with XELODA, if needed yur dctr may decide t: change yur dse f XELODA treat yu with XELODA less ften tell yu t stp taking XELODA until certain side effects get better r g away stp yur treatment with XELODA if yu have certain side effects and they are severe If yu take t much XELODA, call yur dctr r g t the nearest emergency rm right away. What are the pssible side effects f XELODA? XELODA may cause serius side effects including: See What is the mst imprtant infrmatin I shuld knw abut XELODA?. diarrhea. Diarrhea is cmmn with XELODA and can smetimes be severe. Stp taking XELODA and call yur dctr right away if the number f bwel mvements yu have in a day increases by 4 r mre than is usual fr yu. Ask yur dctr abut what medicines yu can take t treat yur diarrhea. If yu have severe bldy diarrhea with severe abdminal pain and fever, call yur dctr r g t the nearest emergency rm right away. heart prblems. XELODA can cause heart prblems including: heart attack and decreased bld flw t the heart, chest pain, irregular heartbeats, changes in the electrical activity f yur heart seen n an electrcardigram (ECG), prblems with yur heart muscle, heart failure, and sudden death. Stp taking XELODA and call yur dctr right away if yu get any f the fllwing symptms: chest pain shrtness f breath feeling faint irregular heartbeats r skipping beats sudden weight gain swllen ankles r legs unexplained tiredness lss f t much bdy fluid (dehydratin) and kidney failure. Dehydratin can happen with XELODA and may cause sudden kidney failure that 43

4 can lead t death. Yu are at higher risk if yu have kidney prblems befre taking XELODA and als take ther medicines that can cause kidney prblems. Nausea, and vmiting are cmmn with XELODA. If yu lse yur appetite, feel weak, and have nausea, vmiting, r diarrhea, yu can quickly becme dehydrated. Stp taking XELODA and call yur dctr right away if yu: vmit 2 r mre times in a day. are nly able t eat r drink a little nw and then, r nt at all due t nausea. have diarrhea. See diarrhea abve. serius skin and muth reactins. XELODA can cause serius skin reactins that may lead t death. Tell yur dctr right away if yu develp a skin rash, blisters and peeling f yur skin. Yur dctr may tell yu t stp taking XELODA if yu have a serius skin reactin. D nt take XELODA again if this happens. XELODA can als cause hand and ft syndrme. Hand and ft syndrme is cmmn with XELODA and can cause yu t have numbness and changes in sensatin in yur hands and feet, r cause redness, pain, swelling f yur hands and feet. Stp taking XELODA and call yur dctr right away if yu have any f these symptms and yu are nt able t d yur usual activities. yu may get sres in yur muth r n yur tngue when taking XELODA. Stp taking XELODA and call yur dctr if yu get painful redness, swelling, r ulcers in yur muth and tngue, r if yu are having prblems eating. Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. increased level f bilirubin in yur bld and liver prblems. Increased bilirubin in yur bld is cmmn with XELODA. Yur dctr will check yu fr these prblems during treatment with XELODA. decreased white bld cells, platelets, and red bld cell cunts. Yur dctr will d bld tests during treatment with XELODA t check yur bld cell cunts. If yur white bld cell cunt is very lw, yu are at increased risk fr infectin. Call yur dctr right away if yu develp a fever f F r greater r have ther signs and symptms f infectin. Peple 80 years f age r lder may be mre likely t develp severe r serius side effects with XELODA. The mst cmmn side effects f XELODA include: 44

5 diarrhea hand and ft syndrme nausea vmiting stmach-area (abdminal) pain tiredness weakness increased amunts f red bld cell breakdwn prducts (bilirubin) in yur bld These are nt all the pssible side effects f XELODA. 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 shuld I stre XELODA? Stre XELODA at rm temperature between 68 F t 77 F (20 C t 25 C). Keep XELODA in a tightly clsed cntainer. Keep XELODA and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f XELODA. Medicines are smetimes prescribed fr cnditins that are nt mentined in patient infrmatin leaflets. D nt use XELODA fr a cnditin fr which it was nt prescribed. D nt give XELODA t ther peple, even if they have the same symptms yu have. It may harm them. Yu can ask yur pharmacist r dctr fr infrmatin abut XELODA that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in XELODA? Active ingredient: capecitabine Inactive ingredients: anhydrus lactse, crscarmellse sdium, hydrxyprpyl methylcellulse, micrcrystalline cellulse, magnesium stearate and purified water. The peach r light peach film cating cntains hydrxyprpyl methylcellulse, talc, titanium dixide, and synthetic yellw and red irn xides. This Patient Infrmatin has been apprved by the U.S. Fd and Drug Administratin. 45

6 Revised: OCT 2014 XELODA is a registered trademark f Hffmann-La Rche, Inc Genentech, Inc. All rights reserved. 46