Xeljanz Yambiro: Inogona Kuwedzera Njodzi Yematambudziko Emoyo uye Kenza

Product: Xeljanz uye Xeljanz XR (tofacitinib), mushonga unoshandiswa kurapa rheumatoid arthritis, psoriatic arthritis uye ulcerative colitis.

Issue: Hutano Canada's chengetedzo wongororo yakawana chinongedzo pakati pekushandiswa kweXeljanz neXeljanz XR (tofacitinib) uye njodzi dzezvakakomba zvine chekuita nemoyo uye kenza.

Zvaunofanira kuita: Usamira kana kushandura chipimo chako cheXeljanz kana Xeljanz XR (tofacitinib) usina kutanga wataura nenyanzvi yako yehutano.

Hutano Canada yakapedza ongororo yekuchengetedza iyo yakasimbisa kubatana pakati pekushandiswa kweXeljanz/Xeljanz XR uye nenjodzi dzakakura dzezvinetso zvakakomba zvine chekuita nemoyo negomarara, kunyanya muvarwere vakura, varwere varipo kana vekare vanoputa, uye varwere vane moyo kana kenza. ngozi zvinhu. Ongororo yeHealth Canada yakawanawo kuti varwere vese vanobatwa neXeljanz 10 mg kaviri zuva nezuva vaive nenjodzi yakanyanya yekufa, kugwamba kweropa uye zvirwere zvakakomba, zvichienzaniswa nevarwere vanobatwa neXeljanz 5 mg kaviri pazuva kana tumor necrosis factor inhibitors (TNFi).

Nekuda kweizvozvo, Health Canada yakashanda nemugadziri kugadzirisa zvinyorwa zvechigadzirwa kuti iwedzere kusimbisa yambiro panjodzi dzematambudziko akakomba ane moyo uye cancer. Vanamazvikokota vezvehutano vakaziviswa nezvekuvandudzwa uku kuitira kuti varaire varwere vavo.

Kuve nechokwadi chekuti mabhenefiti anodarika njodzi muvarwere vanogamuchira Xeljanz/Xeljanz XR, iyo yakatenderwa kushandiswa kwerheumatoid arthritis, chirwere che immune system chinokonzera kukuvadzwa uye kuzvimba kwemajoini, chave kugumira kune vamwe varwere vasingakwanise kushandisa mamwe madhiragi echirwere ichi. kana kuti mimwe mishonga miviri yakasiyana isingashande. Nhamba yepamusoro yeXeljanz 10 mg kaviri zuva rega rega inobvumirwa chete kune varwere vane ulcerative colitis, kuputika kwematumbo makuru kunokonzera maronda uye kubuda ropa, avo vasina kupindura zvakanaka kune mamwe mishonga. Kune varwere vane ulcerative colitis, ruzivo rwekuraira rinokurudzira kuti vashandise dosi yakaderera inoshanda uye kwenguva pfupi inodiwa kuti vabatsire kuvandudza mamiriro avo.

Health Canada yakatangawo kuongorora kutsva kwekuchengetedza njodzi dzinogona kuitika dzematambudziko akakomba ane chekuita nemoyo, kenza uye kugwamba kweropa nemamwe madhiragi maviri ekirasi imwechete seXeljanz/Xeljanz XR (kureva Olumiant naRinvoq) anoshanda zvakafanana pakurapwa kwe zvirwere zvakafanana.

Hutano Canada icharamba ichitarisa ruzivo rwekuchengetedza runosanganisira Xeljanz/Xeljanz XR, sezvainoita kune zvese zvigadzirwa zvehutano pamusika weCanada, kuona uye kuongorora zvinogona kukuvadza. Hutano Canada inotora danho rakakodzera uye nenguva kana njodzi nyowani dzehutano dzaonekwa.

Zvaunofanira kuita:

•             Taura nanyanzvi wako wezvehutano pamusoro pezvinobvira panjodzi yechirwere chemwoyo usati watanga kunwa Xeljanz/Xeljanz XR.

•             Bata chiremba wako pakarepo uye womira kutora Xeljanz/Xeljanz XR kana ukava nezviratidzo nezviratidzo zvedambudziko remwoyo. Zviratidzo zvinogona kusanganisira:

o            kutsva kana kuwedzera kurwadziwa kwechipfuva;

o            kutadza kufema;

o            kurova kwemwoyo kusingaite; kana

o            kuzvimba kwemakumbo.

•             Taura nachiremba wako usati watora Xeljanz/Xeljanz XR kana uine kana kuti uine chero rudzi rwegomarara.

•             Ziva kuti kugwamba kweropa mutsinga dzemakumbo kana maoko ako (deep vein thrombosis, DVT), arterial (arterial thrombosis) kana mapapu (pulmonary embolism, PE) zvinogona kuitika mune vamwe vanhu vanotora Xeljanz/Xeljanz XR. Izvi zvinogona kuisa upenyu pangozi uye kukonzera rufu.

•             Misa Xeljanz/Xeljanz XR uye tsvaga rubatsiro rwekuchipatara kana ukaona zviratidzo kana zviratidzo zvekugwamba kweropa pagumbo kana paruoko rwako (zvakadai sokuzvimba, kurwadziwa kana kupfava kwegumbo kana ruoko) kana mumapapu ako (zvakadai sezvisingatsananguriki. kurwadziwa muchipfuva kana kutadza kufema).

•             Bata chiremba wako kana une zviratidzo zveutachiona (zvakadai sefivha, kudikitira, kupindwa nechando, kukosora, nezvimwewo). Kana hutachiona hwakakomba hukamuka, rega kutora XELJANZ/XELJANZ XR wobva wafonera nyanzvi yako yehutano ipapo.

Varwere vanofanirwa kubata nyanzvi yavo yehutano kuti vawane rumwe ruzivo nezve iyi ruzivo rutsva rwekuchengetedza.

Kana iwe uri nyanzvi yezvehutano:

•             Funga nezvezvakanakira nenjodzi kumurwere mumwe nemumwe asati atanga kana kuenderera mberi nekurapa neXeljanz/Xeljanz XR, kunyanya muvarwere vakura, muvarwere vari kuputa pari zvino kana kuti vakamboputa, vane zvimwe zvirwere zvemoyo , uye avo vane chirwere chinozivikanwa chisiri chegomarara reganda risiri melanoma.

•            Zivisai varwere kuti Xeljanz/Xeljanz XR inogona kuwedzera njodzi yavo yezviitiko zvakakomba zvemwoyo zvinosanganisira non-fatal myocardial infarction. Raira varwere vese, kunyanya varwere vezera, vasvuta vemazuva ano kana vekare, kana varwere vane zvimwe zvine njodzi yemoyo, kuti vangwarire zviratidzo nezviratidzo zvezviitiko zvemoyo.

•             Udza varwere kuti Xeljanz/Xeljanz XR inogona kuwedzera njodzi yavo yemamwe magomarara, uye kuti gomarara remapapu, lymphoma nemamwe magomarara zvakaonekwa muvarwere vanotora Xeljanz. Raira varwere kuti vazivise mutarisiri wavo wehutano kana vakamboita chero rudzi rwegomarara.

•             Rairira varwere kuti vasiye kushandisa Xeljanz/Xeljanz XR uye kufonera nyanzvi yavo yezveutano pakarepo kana vakaona zviratidzo zve thrombosis (kutadza kufema kamwe kamwe, kurwadziwa muchipfuva kunowedzera nekufema, kuzvimba gumbo kana ruoko, kurwadziwa kwegumbo kana kupfava, kutsvuka kana ganda rine ruvara rwegumbo kana ruoko rwakakanganiswa).

•            Dzivisa Xeljanz/Xeljanz XR muvarwere vangangove vari panjodzi yakawedzera yethrombosis.

•             Nyatsoongorora varwere kuona zviratidzo nezviratidzo zveutachiona panguva uye pashure pokurapa neXeljanz/Xeljanz XR.

•             Xeljanz/Xeljanz XR inofanira kuvhiringwa kana murwere akaita utachiona hwakakomba, utachiona hunoita mukana, kana sepsis. Kana murwere akaita hutachiwana hutsva panguva yekurapwa neXeljanz/Xeljanz XR, vanofanira kuongororwa nekukurumidza uye kwakakwana kunoenderana nemurwere asina immunocompromised, uye kurapwa kwakakodzera kweantimicrobial kunofanirwa kutangwa.

•             Shandisa Xeljanz 5 mg kaviri pazuva kana Xeljanz XR 11 mg kamwe pazuva pakurapa rheumatoid arthritis, uye Xeljanz 5 mg kaviri pazuva nokuda kwekurapa psoriatic arthritis. Hutano Canada haina kubvumidza kutengeswa kwedosi yepamusoro ye10 mg kaviri pazuva kune rheumatoid arthritis kana psoriatic arthritis.

•             Muvarwere vane ulcerative colitis, shandisai Xeljanz ine dose yakaderera uye kwenguva pfupi inodiwa kuti muwane/kuchengetedza mhinduro yekurapa.

•             Ziva kuti chiratidzo cheXeljanz/Xeljanz XR muvarwere vane rheumatoid arthritis chave kungogumira kune vamwe varwere vasina kupindura zvakanaka kune mimwe mishonga.

Kubvumbi 6, 2021 - Hutano Canada yakatanga ongororo yekuchengetedza paXeljanz neXeljanz XR (tofacitinib), inoshandiswa kurapa arthritis uye ulcerative colitis. 

Hutano Canada iri kuzivisa vanhu vekuCanada nevashandi vehutano kuti iri kuita ongororo yekuchengetedzwa kweXeljanz neXeljanz XR (tofacitinib) mushure mekuedzwa kwekiriniki kwakaratidza njodzi yakawedzera yematambudziko akakomba ane chekuita nemoyo uye kenza muvatori vechikamu.

Xeljanz uye Xeljanz XR (tofacitinib) mushonga wemishonga unoshandiswa kurapa vanhu vakuru vane mwero kusvika kune zvakanyanya kushanda rheumatoid arthritis, active psoriatic arthritis, kana kuti pakati kusvika kune yakanyanya kusimba ulcerative colitis vasina kupindura zvakanaka kune mamwe mishonga.

Chiyero chekiriniki chakaongorora kuchengetedzwa kwenguva refu kweXeljanz neXeljanz XR (tofacitinib) pamadosi maviri (5 mg kaviri pazuva uye 10 mg kaviri pazuva) muvarwere vane rheumatoid arthritis, vangangoita makore makumi mashanu ezera uye vane nyangwe imwe yemoyo nevascular risk factor. Pfizer, mugadziri wemushonga uyu, akaita muyedzo munyika dzakawanda, kusanganisira Canada.

Ikozvino Canadian label inosanganisira yambiro dzakakomba uye dziviriro dzegomarara uye ruzivo rwekurwiswa kwemoyo, izvo zvaive zvakanyanya kushumwa zvakakomba zvine chekuita nemoyo muyedzo iyi.

Hutano Canada haina kubvumidza kutengeswa kweiyo dhodhi yepamusoro ye10 mg kaviri pazuva kune rheumatoid arthritis kana psoriatic arthritis; iyi dose inobvumirwa chete kune varwere vane ulcerative colitis vasina kupindura zvakanaka kune mamwe mishonga. Kune varwere vane ulcerative colitis, iyo yekuCanada inotsanangura ruzivo inokurudzira kuti vashandise iyo yakaderera inoshanda dose inogoneka kuderedza njodzi yekusagadzikana.

Pakutanga, Health Canada yakanga yaita ongororo yekuchengetedzwa kwemushonga uyu mushure mekuwedzera njodzi dzekugwamba kweropa mumapapu nerufu zvakawanikwa panguva yekuedzwa kwekiriniki. Kutevera iyi ongororo yekuchengetedza muna 2019, Health Canada yakashanda nePfizer kugadzirisa mazita ekuCanada eXeljanz uye Xeljanz XR (tofacitinib) kuti ibatanidze thrombosis seyambiro, uye yakazivisa vekuCanada nevashandi vehutano nezvezvakawanikwa.

Health Canada iri kushanda nePfizer kuti iongorore ruzivo rwekuchengetedza rwuripo rweXeljanz neXeljanz XR (tofacitinib) uye ichazivisa veruzhinji nezve chero zvitsva zvawanikwa zvekuchengetedza, sezvinodiwa, kana ongororo yapera.

Zvaunofanira kuita

Kana iwe uri murwere ari kutora Xeljanz/Xeljanz XR (tofacitinib):

•             Usambomira kana kushandura chipimo chako cheXeljanz kana Xeljanz XR (tofacitinib) usina kutanga wataura nanachiremba wako.

Kana iwe uri nyanzvi yezvehutano:

•             Funga zvakanakira nenjodzi dzeXeljanz neXeljanz XR (tofacitinib) paunenge uchisarudza kuti worayira here kana kuti kuchengeta varwere vari pamushonga.

•             Tevedzera kurudziro muXeljanz neXeljanz XR (tofacitinib) monograph yechigadzirwa chemamiriro chaiwo auri kurapa.

•            Mhan'ara nezvehutano kana kuchengeteka.

Kuzivisa mhedzisiro kune chigadzirwa chehutano kune Health Canada:

•             Fonera toll-free pa1-866-234-2345.

•             Shanyira Webhu peji yeHealth Canada paAdverse Reaction Reporting kuti uwane ruzivo rwekuti unoshuma sei pamhepo, netsamba kana nefax.