Isexwayiso se-Xeljanz: Ingase Yandise Ingozi Yezinkinga Zenhliziyo Nomdlavuza

Product: I-Xeljanz ne-Xeljanz XR (tofacitinib), umuthi owunikezwa ngudokotela osetshenziselwa ukwelapha isifo samathambo, i-psoriatic arthritis kanye ne-ulcerative colitis.

Inkinga: Ukubuyekezwa kokuphepha kwe-Health Canada kwathola ukuxhumana phakathi kokusetshenziswa kwe-Xeljanz ne-Xeljanz XR (tofacitinib) kanye nezingozi zezinkinga ezingathi sína ezihlobene nenhliziyo nomdlavuza.

Okufanele ngikwenze: Ungayeki noma uguqule umthamo wakho we-Xeljanz noma i-Xeljanz XR (tofacitinib) ngaphandle kokuthi uqale ukhulume nochwepheshe bakho bezempilo.

I-Health Canada iphothule isibuyekezo sokuphepha esiqinisekisa ukuxhumana phakathi kokusetshenziswa kwe-Xeljanz/Xeljanz XR kanye nokwanda kwezingozi zezinkinga ezingathi sína ezihlobene nenhliziyo nomdlavuza, ikakhulukazi ezigulini esezikhulile, iziguli ezibhemayo okwamanje noma zesikhathi esidlule, kanye neziguli ezinenhliziyo nemithambo yegazi noma umdlavuza. izinto eziyingozi. Ukubuyekezwa kwe-Health Canada kuphinde kwathola ukuthi zonke iziguli ezelashwa nge-Xeljanz 10 mg kabili ngosuku zazisengozini enkulu yokufa, amahlule egazi kanye nezifo ezimbi kakhulu, uma kuqhathaniswa neziguli eziphathwa nge-Xeljanz 5 mg kabili ngosuku noma ama-tumor necrosis factor inhibitors (TNFi).

Ngenxa yalokho, i-Health Canada isebenze nomkhiqizi ukuthuthukisa amalebula omkhiqizo ukuze kuqhubeke ukuqinisa izexwayiso ngezingozi zezinkinga ezinkulu ezihlobene nenhliziyo nomdlavuza. Ochwepheshe bezokunakekelwa kwempilo bazisiwe ngalezi zibuyekezo ukuze baluleke iziguli zabo.

Ukuqinisekisa ukuthi izinzuzo zidlula izingozi ezigulini ezithola i-Xeljanz/Xeljanz XR, ukusetshenziswa okugunyaziwe kwe-rheumatoid arthritis, isifo sesimiso sokuzivikela ezifweni esidala ukulimala nokuvuvukala kwamalunga, manje sekukhawulelwe ezigulini ezithile ezingakwazi ukusebenzisa ezinye izidakamizwa kulesi simo. noma lapho okungenani eminye imithi emibili ehlukene ingasebenzi. Umthamo ophezulu we-Xeljanz 10 mg kabili ngosuku ugunyazwe kuphela ezigulini ezine-ulcerative colitis, ukuvuvukala kwamathumbu amakhulu okubangela izilonda nokopha, ezingazange zisabele kahle kweminye imithi. Ezigulini ezine-ulcerative colitis, ulwazi olunikezwayo luncoma ukuthi zisebenzise umthamo ophansi kakhulu osebenzayo kanye nesikhathi esifushane esidingekayo ukuze zizisize zithuthukise isimo sazo.

I-Health Canada iphinde iqale ukubuyekezwa okusha kokuphepha kwezingozi ezingaba khona zezinkinga ezingathi sína ezihlobene nenhliziyo, umdlavuza namahlule egazi nezinye izidakamizwa ezimbili zesigaba esifanayo njenge-Xeljanz/Xeljanz XR (okungukuthi, u-Olumiant no-Rinvoq) ezisebenza ngokufanayo ekwelapheni izifo ezifanayo.

I-Health Canada izoqhubeka nokuqapha ulwazi lokuphepha olubandakanya i-Xeljanz/Xeljanz XR, njengoba yenza kuyo yonke imikhiqizo yezempilo emakethe yaseCanada, ukuze ibone futhi ihlole umonakalo ongase ube khona. I-Health Canada izothatha izinyathelo ezifanele futhi ezifika ngesikhathi uma kutholakala ubungozi obusha bezempilo.

Okufanele ukwenze:

• Khuluma nochwepheshe wakho wezempilo mayelana nezici ezingaba yingozi yesifo senhliziyo ngaphambi kokuba uqale ukuphuza i-Xeljanz/Xeljanz XR.

• Thinta uchwepheshe wakho wezempilo ngokushesha futhi uyeke ukuphuza i-Xeljanz/Xeljanz XR uma uba nezimpawu nezimpawu zenkinga yenhliziyo. Izimpawu zingabandakanya:

o Ubuhlungu besifuba obusha noma obuba bubi nakakhulu;

o ukuphelelwa umoya;

o ukushaya kwenhliziyo okungajwayelekile; noma

o ukuvuvukala kwemilenze.

• Khuluma nochwepheshe wakho wezempilo ngaphambi kokuthi uphuze i-Xeljanz/Xeljanz XR uma unomdlavuza noma unonoma yiluphi uhlobo.

• Qaphela ukuthi amahlule egazi emithanjeni yemilenze noma ezingalweni zakho (deep vein thrombosis, DVT), imithambo yegazi (arterial thrombosis) noma amaphaphu (i-pulmonary embolism, PE) kungenzeka kwabanye abantu abathatha i-Xeljanz/Xeljanz XR. Lokhu kungase kube ukuphila engozini futhi kubangele ukufa.

• Misa i-Xeljanz/Xeljanz XR futhi ufune usizo lwezokwelapha ngokushesha uma uba nanoma yiziphi izimpawu noma izimpawu zehlule legazi emlenzeni noma engalweni yakho (njengokuvuvukala, ubuhlungu noma ukuthamba emlenzeni noma engalweni) noma ephashini lakho (njengokungachazeki kungazelelwe. ubuhlungu besifuba noma ukuphelelwa umoya).

• Xhumana nochwepheshe wezempilo uma unezimpawu noma izimpawu zokutheleleka (njengomkhuhlane, ukujuluka, ukugodola, ukukhwehlela, njll.). Uma ukutheleleka okunzima kuvela, yeka ukuthatha i-XELJANZ/XELJANZ XR bese uthintana nochwepheshe wakho wezempilo ngokushesha.

Iziguli kufanele zithinte uchwepheshe wazo wezokunakekelwa kwempilo ukuze uthole imininingwane eyengeziwe ngalolu lwazi olusha lokuphepha.

Uma uchwepheshe wezokunakekelwa kwempilo:

• Cabangela izinzuzo nezingozi zesiguli ngasinye ngaphambi kokuqala noma ukuqhubeka nokwelapha nge-Xeljanz/Xeljanz XR, ikakhulukazi ezigulini esezikhulile, ezigulini ezibhemayo okwamanje noma esikhathini esidlule, lezo ezinezinye izici zenhliziyo nemithambo yegazi noma eziyingozi, lezo eziqala ukugula. , kanye nalabo abanomdlavuza owaziwayo ngaphandle komdlavuza wesikhumba ongelona imelanoma.

• Yazisa iziguli ukuthi i-Xeljanz/Xeljanz XR ingase yenyuse ubungozi bezehlakalo ezimbi zenhliziyo nemithambo yegazi okuhlanganisa ne-non-fatal myocardial infarction. Yalela zonke iziguli, ikakhulukazi iziguli esezikhulile, ababhemayo bamanje noma abadlule, noma iziguli ezinezinye izici ezisengozini yenhliziyo, ukuthi ziqaphele izimpawu nezimpawu zezehlakalo zenhliziyo nemithambo yegazi.

• Yazisa iziguli ukuthi i-Xeljanz/Xeljanz XR ingase yenyuse ingozi yokuba nomdlavuza othile, nokuthi umdlavuza wamaphaphu, i-lymphoma neminye imidlavuza iye yabonwa ezigulini ezithatha i-Xeljanz. Yalela iziguli ukuthi zazise abahlinzeki bazo bezempilo uma zike zaba nanoma yiluphi uhlobo lomdlavuza.

• Yazisa iziguli ukuthi ziyeke ukuphuza i-Xeljanz/Xeljanz XR futhi zishayele uchwepheshe wazo wezempilo ngokushesha uma zithola noma yiziphi izimpawu ze-thrombosis (ukuphelelwa umoya kungazelelwe, ubuhlungu besifuba buba bumbi nakakhulu ngenxa yokuphefumula, ukuvuvukala komlenze noma ingalo, ubuhlungu bomlenze noma ukuzwela, ubomvu noma isikhumba esishintshile emlenzeni noma engalweni ethintekile).

• Gwema i-Xeljanz/Xeljanz XR ezigulini ezingase zibe sengcupheni eyengeziwe ye-thrombosis.

• Qaphela iziguli eduze ukuze uthole izimpawu nezimpawu zokutheleleka ngesikhathi nangemuva kokwelashwa nge-Xeljanz/Xeljanz XR.

• I-Xeljanz/Xeljanz XR kufanele iphazamiseke uma isiguli siba nezifo ezimbi kakhulu, izifo ezingosomathuba, noma i-sepsis. Uma isiguli siba nokutheleleka okusha ngesikhathi sokwelashwa nge-Xeljanz/Xeljanz XR, kufanele sihlole ngokushesha futhi siqedele ukuxilongwa okufanele isiguli esingakwazi ukuzivikela ezifweni, futhi kuqalwe ukwelashwa okufanele ngama-antimicrobial.

• Sebenzisa i-Xeljanz 5 mg kabili ngosuku noma i-Xeljanz XR 11 mg kanye ngosuku ukuze welaphe isifo samathambo, kanye ne-Xeljanz 5 mg kabili nsuku zonke ukuze welaphe i-psoriatic arthritis. I-Health Canada ayikugunyazanga ukuthengiswa kwethamo eliphezulu lika-10 mg kabili ngosuku nge-rheumatoid arthritis noma i-psoriatic arthritis.

• Ezigulini ezine-ulcerative colitis, sebenzisa i-Xeljanz ngedosi esebenza ngempumelelo ephansi kakhulu nangesikhathi esifushane esidingekayo ukuze uzuze/ugcine impendulo yokwelapha.

• Qaphela ukuthi inkomba ye-Xeljanz/Xeljanz XR ezigulini ze-rheumatoid arthritis manje isilinganiselwe ezigulini ezithile ezingazange zisabele kahle kweminye imithi.

Ephreli 6, 2021 - I-Health Canada iqale isibuyekezo sokuphepha ku-Xeljanz ne-Xeljanz XR (tofacitinib), esetshenziselwa ukwelapha isifo sokuqaqamba kwamalunga nesifo sokuqaqamba kwamathumbu. 

I-Health Canada yazisa abantu baseCanada nabasebenzi bezempilo ukuthi yenza ukubuyekezwa kokuphepha kwe-Xeljanz ne-Xeljanz XR (tofacitinib) ngemva kokuhlolwa komtholampilo kukhombe ingozi eyengeziwe yezinkinga ezingathi sína ezihlobene nenhliziyo kanye nomdlavuza kubahlanganyeli bocwaningo.

I-Xeljanz ne-Xeljanz XR (i-tofacitinib) iyisidakamizwa esinikezwa ngudokotela esisetshenziselwa ukwelapha abantu abadala abane-arthritis ye-rheumatoid emaphakathi kuya eqinile, isifo samathambo esisebenzayo se-psoriatic, noma i-ulcerative colitis emaphakathi ukuya kwenamandla kakhulu abangazange baphendule kahle kweminye imithi.

Ukuhlolwa komtholampilo kuphenye ukuphepha kwesikhathi eside kwe-Xeljanz ne-Xeljanz XR (tofacitinib) imithamo emibili (5 mg kabili ngosuku no-10 mg kabili ngosuku) ezigulini ezinesifo samathambo, ezineminyaka okungenani engu-50 ubudala futhi ezineminyaka engu-XNUMX ubudala. okungenani isici esisodwa esiyingozi senhliziyo nemithambo yegazi. U-Pfizer, ongumkhiqizi womuthi, wenze ucwaningo emazweni amaningi, okuhlanganisa ne-Canada.

Ilebula yamanje yase-Canadian ihlanganisa izexwayiso ezibucayi nezinyathelo zokuphepha zomdlavuza kanye nolwazi lokuhlaselwa yinhliziyo, obekuyizinkinga ezimbi kakhulu ezihlobene nenhliziyo ezibikwa kakhulu kulolu cwaningo.

I-Health Canada ayikugunyazanga ukuthengiswa kwethamo eliphezulu lika-10 mg kabili ngosuku nge-rheumatoid arthritis noma i-psoriatic arthritis; lesi silinganiso sigunyazwe kuphela iziguli ezine-ulcerative colitis ezingazange zisabele kahle kweminye imithi. Ezigulini ezine-ulcerative colitis, imininingwane yaseCanada echazayo incoma ukuthi basebenzise umthamo ophansi kakhulu osebenzayo ukuze behlise ubungozi bokusabela okungekuhle.

Phambilini, i-Health Canada yenze ukubuyekezwa kokuphepha kwalo muthi ngemuva kokuthi kutholakale ubungozi bokwanda kwamahlule egazi emaphashini nokufa ngesikhathi sokuhlolwa komtholampilo. Ngemva kwalokhu kubuyekezwa kokuphepha ngo-2019, i-Health Canada yasebenza ne-Pfizer ukuze ibuyekeze ukulebula kwaseCanada kwe-Xeljanz ne-Xeljanz XR (tofacitinib) ukuze kufakwe i-thrombosis njengesexwayiso, futhi yazisa abantu baseCanada nabasebenzi bezempilo ngokutholakele.

I-Health Canada isebenza ne-Pfizer ukuhlola ulwazi olutholakalayo lokuphepha lwe-Xeljanz ne-Xeljanz XR (tofacitinib) futhi izokwazisa umphakathi nganoma yikuphi okutholakele okusha kokuphepha, njengoba kudingeka, uma ukubuyekezwa sekuqediwe.

Okufanele ukwenze

Uma uyisiguli esithatha i-Xeljanz/Xeljanz XR (tofacitinib):

• Ungayeki noma ushintshe umthamo wakho we-Xeljanz noma i-Xeljanz XR (tofacitinib) ngaphandle kokuqala ukhulume nochwepheshe bakho bezempilo.

Uma uchwepheshe wezokunakekelwa kwempilo:

• Cabangela izinzuzo nezingozi ze-Xeljanz ne-Xeljanz XR (tofacitinib) lapho unquma ukuthi kufanele unqume noma ugcinwe iziguli ngomuthi.

• Landela izincomo ku-Xeljanz ne-Xeljanz XR (tofacitinib) monograph yomkhiqizo ngesimo esithile oyelaphayo.

• Bika impilo noma izinkinga zokuphepha.

Ukubika umthelela oseceleni womkhiqizo wezempilo ku-Health Canada:

• Shayela ucingo lwamahhala ku-1-866-234-2345.

• Vakashela ikhasi leWebhu le-Health Canada kokuthi Ukubika Okungalungile ukuze uthole ulwazi lokuthi ubika kanjani ku-inthanethi, ngeposi noma ngefeksi.