Product: ʻO Xeljanz a me Xeljanz XR (tofacitinib), he lāʻau lapaʻau i hoʻohana ʻia no ka mālama ʻana i ka maʻi rheumatoid, ka ʻāʻī psoriatic a me ka colitis ulcerative.
Paʻi: Ua loaʻa i ka loiloi palekana o Health Canada kahi loulou ma waena o ka hoʻohana ʻana iā Xeljanz a me Xeljanz XR (tofacitinib) a me nā pilikia o nā pilikia pili puʻuwai koʻikoʻi a me ka maʻi kanesa.
Pehea e hana ai: Mai hooki a hoʻololi paha i kāu ʻano o Xeljanz a i ʻole Xeljanz XR (tofacitinib) me ka ʻole e kamaʻilio mua i kāu kauka mālama ola.
Ua hoʻopau ʻo Health Canada i kahi loiloi palekana e hōʻoia i kahi loulou ma waena o ka hoʻohana ʻana iā Xeljanz/Xeljanz XR a me ka piʻi nui ʻana o nā pilikia pili i ka puʻuwai a me ka maʻi kanesa, ʻoi aku hoʻi i nā poʻe maʻi ʻelemakule, nā mea maʻi i kēia manawa a i ʻole nā mea puhi puhi, a me nā maʻi me ka cardiovascular a i ʻole ka maʻi kanesa. mea pilikia. Ua ʻike pū ʻia ka loiloi ʻo Health Canada ʻo nā mea maʻi āpau i mālama ʻia me Xeljanz 10 mg ʻelua i kēlā me kēia lā ua ʻoi aku ka nui o ka hopena o ka make, ke koko koko a me nā maʻi koʻikoʻi, ke hoʻohālikelike ʻia me nā maʻi i mālama ʻia me Xeljanz 5 mg ʻelua i kēlā me kēia lā a i ʻole tumo necrosis factor inhibitors (TNFi).
ʻO ka hopena, ua hana pū ʻo Health Canada me ka mea hana e hōʻano hou i nā lepili huahana e hoʻoikaika hou i nā ʻōlelo aʻo e pili ana i nā pilikia o nā pilikia pili puʻuwai koʻikoʻi a me ka maʻi kanesa. Ua hoʻomaopopo ʻia nā limahana mālama ola i kēia mau mea hou i mea e aʻo ai i kā lākou poʻe maʻi.
No ka hōʻoia ʻana i nā pōmaikaʻi ma mua o nā pilikia o nā maʻi e loaʻa ana iā Xeljanz/Xeljanz XR, ʻo ka hoʻohana ʻia ʻana no ka rheumatoid arthritis, kahi maʻi ʻōnaehana pale e hoʻopōʻino a me ka mumū o nā hono, ua kaupalena ʻia i kekahi mau maʻi hiki ʻole ke hoʻohana i nā lāʻau ʻē aʻe no kēia maʻi. a i ʻole ʻelua mau lāʻau lapaʻau ʻē aʻe i hana ʻole. ʻO ka nui kiʻekiʻe o Xeljanz 10 mg ʻelua i kēlā me kēia lā ua ʻae wale ʻia no nā poʻe maʻi me ka ulcerative colitis, kahi ʻāʻī nui o ka ʻōpū e hoʻoulu ai i nā ʻeha a me ke koko, ʻaʻole i pane maikaʻi i nā lāʻau ʻē aʻe. No nā poʻe maʻi me ka ulcerative colitis, ʻōlelo ka ʻike kuhikuhi e hoʻohana lākou i ka nui haʻahaʻa haʻahaʻa a no ka manawa pōkole e pono ai e kōkua iā lākou e hoʻomaikaʻi i ko lākou kūlana.
Ua hoʻomaka pū ʻo Health Canada i kahi loiloi palekana hou e pili ana i nā pilikia e pili ana i nā pilikia pili puʻuwai koʻikoʻi, ka maʻi kanesa a me nā clots koko me ʻelua mau lāʻau lapaʻau o ka papa like me Xeljanz/Xeljanz XR (ʻo ia hoʻi ʻo Olumiant a me Rinvoq) e hana like no ka mālama ʻana o nā maʻi like.
E hoʻomau ka Health Canada i ka nānā ʻana i ka ʻike palekana e pili ana iā Xeljanz/Xeljanz XR, e like me ia no nā huahana olakino āpau ma ka mākeke Kanada, e ʻike a loiloi i nā pōʻino. E hana ʻo Health Canada i nā hana kūpono a me ka manawa inā e ʻike ʻia nā pilikia olakino hou.
He aha kāu e hana ai:
• E kamaʻilio me kāu ʻoihana mālama ola e pili ana i nā kumu pilikia o ka maʻi puʻuwai ma mua o kou hoʻomaka ʻana e lawe iā Xeljanz/Xeljanz XR.
• E kelepona koke aku i kāu ʻoihana mālama ola a hoʻōki i ka lawe ʻana iā Xeljanz/Xeljanz XR inā loaʻa iā ʻoe nā hōʻailona a me nā hōʻailona o ka pilikia naʻau. Hiki i nā hōʻailona ke komo:
o ka ʻeha hou a i ʻole ka ʻeha o ka umauma;
o ka hanu hanu;
ʻo ka puʻuwai kū ʻole; a i ʻole
o ka pehu o na wawae.
• E kamaʻilio me kāu ʻoihana mālama ola ma mua o kou lawe ʻana iā Xeljanz/Xeljanz XR inā loaʻa iā ʻoe kekahi ʻano maʻi kanesa.
• E makaʻala e hiki ke hoʻopaʻa ʻia ke koko i loko o nā aʻa o kou mau wāwae a i ʻole nā lima (deep vein thrombosis, DVT), nā ʻaʻa (arterial thrombosis) a i ʻole nā māmā (pulmonary embolism, PE) hiki ke loaʻa i kekahi poʻe e lawe ana i ka Xeljanz/Xeljanz XR. He mea weliweli paha kēia i ke ola a make.
• E hooki i ka Xeljanz/Xeljanz XR a e imi koke i ke kokua lapaau ina e loaa ia oe kekahi mau hoailona o ke koko koko ma kou wawae a lima paha (e like me ka pehu, eha a palupalu paha ma ka wawae a lima paha) ai ole ma kou akemama (e like me ka wehewehe koke ole ia. ʻeha o ka umauma a i ʻole pōkole o ka hanu).
• E kelepona i kāu kauka lapaʻau inā loaʻa iā ʻoe nā hōʻailona a i ʻole nā hōʻailona o kahi maʻi (e like me ke kuni, ka houhu, ke anu, ka ʻū, a pēlā aku). Inā ulu mai kahi ma'i ko'iko'i, e ho'ōki i ka lawe 'ana iā XELJANZ/XELJANZ XR a e kelepona koke aku i kāu 'oihana mālama ola.
Pono nā maʻi e hoʻokaʻaʻike i kā lākou ʻoihana mālama ola no nā kikoʻī hou aku e pili ana i kēia ʻike palekana hou.
Inā he ʻoihana mālama ola ʻoe:
E noʻonoʻo i nā pōmaikaʻi a me nā pilikia no ka mea maʻi hoʻokahi ma mua o ka hoʻomaka ʻana a i ʻole ka hoʻomau ʻana i ka lāʻau me Xeljanz/Xeljanz XR, ʻoi loa i nā maʻi geriatric, i nā poʻe maʻi i kēia manawa a i ʻole nā mea puhi paka, ka poʻe me nā kumu pilikia ʻē aʻe o ka maʻi cardiovascular a malignancy, ka poʻe e ulu ana i kahi maʻi maʻi. , a me ka poe i ikeia he ma'i ma'i ma'i 'oko'a o ka ma'i 'a'ai 'ole melanoma.
• E haʻi aku i nā poʻe maʻi e hoʻonui paha ʻo Xeljanz/Xeljanz XR i ko lākou pilikia i nā hanana maʻi maʻi puʻuwai koʻikoʻi me ka infarction myocardial non-fatal. E aʻo aku i nā poʻe maʻi āpau, ʻoi aku ka nui o nā maʻi geriatric, nā mea puhi puhi o kēia manawa a i hala, a i ʻole nā mea maʻi me nā mea pilikia ʻē aʻe o ka naʻau, e makaʻala i nā hōʻailona a me nā hōʻailona o nā hanana cardiovascular.
• E haʻi aku i nā poʻe maʻi e hoʻonui paha ʻo Xeljanz/Xeljanz XR i ko lākou pilikia i kekahi mau maʻi maʻi ʻaʻai, a ua ʻike ʻia ka maʻi maʻi ʻāʻī, lymphoma a me nā maʻi maʻi ʻē aʻe i nā maʻi e lawe ana iā Xeljanz. E aʻo aku i nā poʻe maʻi e haʻi aku i kā lākou mea mālama ola inā loaʻa iā lākou kekahi ʻano maʻi kanesa.
E aʻo i nā poʻe maʻi e hoʻōki i ka lawe ʻana iā Xeljanz/Xeljanz XR a e kāhea koke i kā lākou ʻoihana mālama ola inā loaʻa iā lākou kekahi hōʻailona o ka thrombosis (pōkole o ka hanu, ʻeha ka umauma me ka hanu, pehu ʻana o ka wāwae a i ʻole ka lima, ka ʻeha wāwae a palupalu paha, ʻulaʻula a ʻulaʻula paha. ʻeleʻele ka ʻili ma ka wāwae a lima paha).
• Hōʻalo iā Xeljanz/Xeljanz XR i nā poʻe maʻi e piʻi nui ana i ka thrombosis.
• E nānā pono i nā maʻi no nā hōʻailona a me nā hōʻailona o ka maʻi i ka wā a ma hope o ka mālama ʻana me Xeljanz/Xeljanz XR.
• Pono ka Xeljanz/Xeljanz XR inā loaʻa ka maʻi i kahi maʻi koʻikoʻi, kahi maʻi opportunistic, a i ʻole sepsis. Inā hoʻomohala ka mea maʻi i kahi maʻi hou i ka wā o ka mālama ʻana me Xeljanz/Xeljanz XR, pono lākou e hoʻāʻo wikiwiki a hoʻopau i ka diagnostic diagnostic kūpono no ka mea maʻi immunocompromised, a pono e hoʻomaka i ka lāʻau antimicrobial kūpono.
• E hoʻohana i ka Xeljanz 5 mg ʻelua i kēlā me kēia lā a i ʻole Xeljanz XR 11 mg hoʻokahi i kēlā me kēia lā no ka mālama ʻana i ka maʻi rumatika, a me Xeljanz 5 mg ʻelua i kēlā me kēia lā no ka mālama ʻana i ka maʻi o ka psoriatic arthritis. ʻAʻole ʻae ʻo Health Canada i ke kūʻai ʻana i ka nui o ka nui o 10 mg ʻelua i kēlā me kēia lā no ka rheumatoid arthritis a i ʻole psoriatic arthritis.
• I nā poʻe maʻi me ka ulcerative colitis, e hoʻohana iā Xeljanz ma ka haʻahaʻa haʻahaʻa haʻahaʻa a no ka manawa pōkole e pono ai e hoʻokō / mālama i ka pane therapeutic.
• E hoʻomaopopo i ka hōʻailona no Xeljanz / Xeljanz XR i nā maʻi o ka rumatika rheumatoid i kēia manawa i kaupalena ʻia i kekahi mau maʻi i pane maikaʻi ʻole i nā lāʻau lapaʻau ʻē aʻe.
ʻApelila 6, 2021 - Ua hoʻomaka ʻo Health Canada i kahi loiloi palekana ma Xeljanz a me Xeljanz XR (tofacitinib), i hoʻohana ʻia e mālama i ka ʻāʻī a me ka ulcerative colitis.
Ke hōʻike aku nei ʻo Health Canada i ka poʻe Kanada a me nā limahana mālama olakino e mālama ana ia i kahi loiloi palekana o Xeljanz a me Xeljanz XR (tofacitinib) ma hope o ka hoʻokolohua lapaʻau i ʻike i ka piʻi nui ʻana o nā pilikia pili i ka naʻau a me ka maʻi kanesa i nā mea komo hoʻokolokolo.
ʻO Xeljanz a me Xeljanz XR (tofacitinib) he lāʻau lapaʻau i hoʻohana ʻia no ka mālama ʻana i nā poʻe mākua me ka maʻi rheumatoid maʻemaʻe a koʻikoʻi, ka maʻi maʻi psoriatic ikaika, a i ʻole ka maʻi maʻi ulcerative colitis ʻaʻole i pane maikaʻi i nā lāʻau ʻē aʻe.
Ua noiʻi ka hoʻokolohua lapaʻau i ka palekana no ka wā lōʻihi o Xeljanz a me Xeljanz XR (tofacitinib) ma ʻelua mau kau (5 mg ʻelua i ka lā a me 10 mg ʻelua i ka lā) i nā poʻe maʻi me ka rheumatoid arthritis, nona ka liʻiliʻi o 50 mau makahiki. liʻiliʻi loa i hoʻokahi kumu pilikia cardiovascular. ʻO Pfizer, ka mea hana o ka lāʻau lapaʻau, i alakaʻi i ka hoʻokolokolo ma nā ʻāina he nui, me Kanada.
Aia i loko o ka lepili Kanada i kēia manawa nā ʻōlelo aʻo nui a me ka mālama ʻana no ka maʻi kanesa a me ka ʻike e pili ana i ka hōʻeha puʻuwai, ʻo ia nā pilikia pili puʻuwai koʻikoʻi i hōʻike pinepine ʻia i kēia hoʻokolokolo.
ʻAʻole ʻae ʻo Health Canada i ke kūʻai ʻana i ka nui kiʻekiʻe o 10 mg ʻelua i ka lā no ka rheumatoid arthritis a i ʻole psoriatic arthritis; Ua ʻae wale ʻia kēia ʻāpana no nā poʻe maʻi me ka ulcerative colitis i pane maikaʻi ʻole i nā lāʻau ʻē aʻe. No nā poʻe maʻi me ka ulcerative colitis, ua ʻōlelo ka ʻike kuhikuhi Kanada e hoʻohana lākou i ka haʻahaʻa haʻahaʻa haʻahaʻa e hiki ai ke hoʻohaʻahaʻa i ka hopena o nā hopena ʻino.
Ma mua, ua mālama ʻo Health Canada i kahi loiloi palekana o kēia lāʻau lapaʻau ma hope o ka piʻi ʻana o nā pilikia o nā ʻōpū koko i loko o ka māmā a me ka make i ʻike ʻia i ka wā o kahi hoʻokolohua lapaʻau. Ma hope o kēia loiloi palekana ma 2019, ua hana pū ʻo Health Canada me Pfizer e hōʻano hou i ka hōʻailona Kanada no Xeljanz a me Xeljanz XR (tofacitinib) e hoʻokomo i ka thrombosis ma ke ʻano he ʻōlelo aʻo, a hoʻomaopopo i ka poʻe Kanada a me nā limahana mālama olakino o nā ʻike.
Ke hana nei ʻo Health Canada me Pfizer e loiloi i ka ʻike palekana i loaʻa no Xeljanz a me Xeljanz XR (tofacitinib) a e hoʻolaha i ka lehulehu i nā ʻike palekana hou, inā pono, ke pau ka loiloi.
ʻO kāu mea e hana ai
Inā he maʻi ʻoe e lawe ana iā Xeljanz/Xeljanz XR (tofacitinib):
• Mai hooki a hoololi paha i ka nui o Xeljanz a i ole Xeljanz XR (tofacitinib) me ka olelo mua ole i kou kauka lapaau.
Inā he ʻoihana mālama ola ʻoe:
• E noʻonoʻo i nā pōmaikaʻi a me nā pilikia o Xeljanz a me Xeljanz XR (tofacitinib) i ka wā e hoʻoholo ai inā e kuhikuhi a mālama i nā maʻi i ka lāʻau.
• E hahai i nā ʻōlelo aʻoaʻo ma Xeljanz a me Xeljanz XR (tofacitinib) monograph huahana no ke ʻano kikoʻī āu e mālama nei.
• E hōʻike i nā pilikia olakino a palekana paha.
No ka hōʻike ʻana i kahi hopena ʻaoʻao i kahi huahana olakino iā Health Canada:
• Kāhea me ka uku ʻole ma 1-866-234-2345.
• E kipa i ka ʻaoʻao pūnaewele o Health Canada ma Adverse Reaction Reporting no ka ʻike e pili ana i ka hōʻike ʻana ma ka pūnaewele, ma ka leka uila a ma ka fax.
