Ua ʻae ʻia ʻo Tezspire ma hope o kahi Manaʻo Priority e ka FDA a ma muli o nā hopena mai ka papahana hoʻokolohua lapaʻau PATHFINDER. Ua komo ka palapala noi i nā hualoaʻa mai ka hoʻokolohua pivotal NAVIGATOR Phase 3 kahi i hōʻike ai ʻo Tezspire i ke kūlana kiʻekiʻe ma kēlā me kēia kumu mua a me ke kula kiʻekiʻe kiʻekiʻe o nā mea maʻi me ka hānō koʻikoʻi, i hoʻohālikelike ʻia me ka placebo, ke hoʻohui ʻia i ka lāʻau maʻamau.
ʻO Tezspire kahi mea olaola mua o ka papa no ka hānō koʻikoʻi e hana ana ma ka piko o ka cascade inflammatory ma ka huli ʻana i ka thymic stromal lymphopoietin (TSLP), he cytokine epithelial. ʻO ka Phase 3 a me 2 nā hoʻokolohua lapaʻau, kahi i komo ka lehulehu o nā maʻi hānō koʻikoʻi me ka nānā ʻole i nā biomarkers koʻikoʻi, me ka helu eosinophil koko, ke kūlana maʻi a me ka fractional exhaled nitric oxide (FeNO). ʻaʻole loaʻa kahi phenotype—eosinophilic a allergic—a i ʻole ka palena biomarker i loko o kāna lepili i ʻāpono ʻia.
Ua paʻi ʻia nā hopena mai ka NAVIGATOR Phase 3 hoʻāʻo ma The New England Journal of Medicine i Mei 2021.2 Ma nā noiʻi lapaʻau o Tezspire, ʻo nā hopena ʻino maʻamau ʻo ka nasopharyngitis, ka maʻi o ka ʻōpū hanu kiʻekiʻe a me ke poʻo.
Aia ʻo Tezspire ma lalo o ka loiloi kānāwai ma EU, Iapana a me nā ʻāina ʻē aʻe a puni ka honua.
Hoʻoholo i ke kākoʻo maʻi
Ua kūpaʻa ʻo Amgen a me AstraZeneca i ka hāʻawi ʻana i nā maʻi kūpono i kuhikuhi ʻia ʻo Tezspire me ka hiki ke loaʻa i ka lāʻau lapaʻau. Hiki i nā poʻe maʻi, nā kahu hānai a me nā kauka i makemake i ke kākoʻo a i ʻole nā waiwai ke hoʻopili i ka papahana Tezspire Together e hoʻomaka ana i ka Pōʻakahi, Dec. 20 ma 8:00 am ET ma ke kāhea ʻana iā 1-888-TZSPIRE (1-888-897-7473).
Tezspire™ (tezepelumab-ekko) Hōʻike US
ʻO Tezspire kahi lāʻau lapaʻau mua i hōʻike ʻia no ka mālama ʻana i ka mālama ʻana i nā maʻi makua a me nā keiki maʻi ma mua o 12 mau makahiki a ʻoi aku me ka hānō koʻikoʻi.
ʻAʻole hōʻike ʻia ʻo Tezspire no ka hoʻomaha ʻana i ka bronchospasm a i ʻole ke kūlana asthmaticus.
Tezspire™ (tezepelumab-ekko) ʻIke Palekana Koʻikoʻi
KA HO'OLO'UI
ʻIke ʻia ka hypersensitivity i ka tezepelumab-ekko a i ʻole nā mea kōkua.
OLELO HOOLAHA A ME KA HUAKAI
ʻO nā hopena hypersensitivity
Hiki ke loaʻa nā hopena hypersensitivity (e laʻa, ʻūhū a me ka conjunctivitis maʻi maʻi) ma hope o ka hoʻohana ʻana iā TEZSPIRE. Hiki ke loaʻa kēia mau hopena i loko o nā hola o ka hoʻohana ʻana, akā i kekahi mau manawa ua lohi ka hoʻomaka ʻana (ʻo ia hoʻi, nā lā). Inā loaʻa ka hopena hypersensitivity, e hoʻomaka i ka mālama kūpono e like me ka hōʻike ʻana ma ke kino a laila e noʻonoʻo i nā pōmaikaʻi a me nā pilikia no ka mea maʻi e hoʻoholo ai inā e hoʻomau a hoʻopau paha i ka mālama ʻana me TEZSPIRE.
Nā hōʻailona hānō nui a i ʻole ka maʻi ʻino
ʻAʻole pono e hoʻohana ʻia ʻo TEZSPIRE e mālama i nā hōʻailona hānō nui, exacerbations acute, bronchospasm acute, a i ʻole status asthmaticus.
Hoemi koke o Corticosteroid Dosage
Mai hoʻopau koke i nā corticosteroids systemic a inhaled i ka hoʻomaka ʻana o ka lāʻau me TEZSPIRE. ʻO ka hoʻemi ʻana i ka maʻi corticosteroid, inā kūpono, pono e hana mālie a hana ʻia ma lalo o ka mākaʻikaʻi pololei a ke kauka. Hiki ke hoʻemi ʻia ka maʻi corticosteroid me nā hōʻailona hoʻihoʻi ʻōnaehana a/a i ʻole ka wehe ʻana i nā kūlana i kāohi mua ʻia e ka systemic corticosteroid therapy.
ʻO ka maʻi parasitic (Helminth).
ʻAʻole ʻike ʻia inā e hoʻoikaika ʻo TEZSPIRE i ka pane o ka mea maʻi e kūʻē i nā maʻi helminth. E mālama i nā poʻe maʻi me nā maʻi helminth ma mua o ka hoʻomaka ʻana i ka lāʻau lapaʻau me TEZSPIRE. Inā loaʻa nā maʻi i ka maʻi i ka loaʻa ʻana o TEZSPIRE a ʻaʻole pane i ka mālama anti-helminth, e hoʻopau iā TEZSPIRE a hiki i ka hoʻoholo ʻana o ka maʻi.
Nā Waihona Attenuated Ola
ʻAʻole i loiloi ʻia ka hoʻohana like ʻana o TEZSPIRE a me nā lāʻau lapaʻau ola attenuated. Pono e ʻalo ʻia ka hoʻohana ʻana i nā lāʻau lapaʻau ola i nā maʻi e loaʻa ana iā TEZSPIRE.
HE MAU OLELO HOOLAHA
ʻO nā hopena ʻino maʻamau (ʻoi aku ma mua o 3%) ʻo ka pharyngitis, arthralgia, a me ka ʻeha hope.
E HANA I NĀ POPULATIONS SPECIFIC
ʻAʻohe ʻikepili e pili ana i ka hoʻohana ʻana o TEZSPIRE i nā wahine hāpai e loiloi no kekahi pilikia pili i ka lāʻau o nā hemahema hānau nui, hāʻule ʻole, a i ʻole nā hopena ʻino ʻē aʻe o ka makuahine a i ʻole ka hānau keiki. ʻOi aku ka nui o ka hoʻoili placental o nā antibodies monoclonal e like me Tezepelumab-ekko i ke kolu o ka trimester o ka hāpai ʻana; No laila, ʻoi aku ka nui o nā hopena i ke keiki hānai i ke kolu o ka trimester o ka hāpai ʻana.
He aha e lawe ʻia mai kēia ʻatikala:
- In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
- 3 It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).
- Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.
