I-Tezspire ivunyiwe kulandela Ukubuyekezwa Okubalulekile Okwenziwa yi-FDA futhi kususelwa kumiphumela evela kuhlelo lwesivivinyo somtholampilo lwe-PATHFINDER. Uhlelo lokusebenza lwaluhlanganisa imiphumela evela ocwaningweni olubalulekile lwe-NAVIGATOR Isigaba sesi-3 lapho i-Tezspire ibonise ukuphakama kuzo zonke izindawo zokugcina eziyinhloko nezibalulekile ezigulini ezine-asthma enzima, uma kuqhathaniswa ne-placebo, lapho yengezwe ekwelapheni okujwayelekile.

I-Tezspire iyi-biologic ye-class-in-class biologic ye-asthma enzima esebenza phezulu kwe-cascade evuthayo ngokukhomba i-thymic stromal lymphopoietin (TSLP), i-epithelial cytokine.3 Iyokuqala futhi kuphela ye-biologic ye-biologic ukunciphisa ngokuqhubekayo futhi ngokuphawulekayo ukukhushulwa kwe-asthma kuyo yonke indawo. Isigaba se-2 kanye nokuhlolwa kwemitholampilo ye-3, okuhlanganisa inani elibanzi leziguli ze-asthma ezinzima kungakhathaliseki ukuthi yiziphi izimpawu ze-biomarker ezibalulekile, okuhlanganisa izibalo ze-eosinophil zegazi, isimo se-allergic kanye ne-fractional exhaled nitric oxide (FeNO) . enganayo i-phenotype—i-eosinophilic noma i-allergic—noma imikhawuko ye-biomarker phakathi kwelebula yayo egunyaziwe.

Imiphumela evela ocwaningweni lweSigaba sesi-3 se-NAVIGATOR yanyatheliswa ku-New England Journal of Medicine ngoMeyi 2021.2 Ocwaningweni lwasemtholampilo lwe-Tezspire, ukusabela okungekuhle okuvame kakhulu kwakuyi-nasopharyngitis, ukutheleleka komgudu wokuphefumula ophezulu kanye nekhanda elibuhlungu.

I-Tezspire ingaphansi kokubuyekezwa okusemthethweni e-EU, Japan nakwamanye amazwe amaningana emhlabeni jikelele.

Ukuzibophezela Ekusekeleni Isiguli

I-Amgen ne-AstraZeneca bazibophezele ekuhlinzekeni iziguli ezifanele ezinqunywe i-Tezspire ngokufinyelela umuthi okufinyelelekayo. Iziguli, abanakekeli nodokotela abadinga ukwesekwa noma izinsiza bangathintana nohlelo lwe-Tezspire Together oluqala ngoMsombuluko, Dec. 20 ngo-8:00 am ET ngokushayela ku-1-888-TZSPIRE (1-888-897-7473).

I-Tezspire™ (tezepelumab-ekko) Inkomba yase-US

I-Tezspire iwumuthi wesigaba sokuqala okhonjiswe ukwelashwa okungeziwe kwesondlo kweziguli zabantu abadala kanye nezingane ezineminyaka engu-12 nangaphezulu ezinesifuba somoya esibi.

I-Tezspire ayibonisiwe ukukhululeka kwe-bronchospasm ebukhali noma isimo se-asthmaticus.

I-Tezspire™ (tezepelumab-ekko) Ulwazi Olubalulekile Lokuphepha

Ukuxhumana

I-hypersensitivity eyaziwayo ku-tezepelumab-ekko noma ama-excipients.

IZIXWAYISO NEZINYATHELO

Ukusabela kwe-Hypersensitivity

Ukusabela kwe-hypersensitivity (isb, ukuqubuka kanye ne-allergic conjunctivitis) kungenzeka ngemuva kokuphathwa kwe-TEZSPIRE. Lokhu kusabela kungenzeka phakathi namahora okuphatha, kodwa kwezinye izimo kuba nokubambezeleka kokuqala (okungukuthi, izinsuku). Esimeni sokusabela kwe-hypersensitivity, qala ukwelashwa okufanele njengoba kubonisiwe ngokomtholampilo bese ucabangela izinzuzo nezingozi zesiguli ngasinye ukuze sinqume ukuthi siqhubeke noma siyeke yini ukwelashwa nge-TEZSPIRE.

Izimpawu Zesifuba Somoya Esinamandla noma Izifo Eziwohlokayo

I-TEZSPIRE akufanele isetshenziselwe ukwelapha izimpawu zesifuba somoya obukhali, ukukhuphuka okukhulu, i-bronchospasm ebukhali, noma isimo se-asthmaticus.

Ukwehliswa Ngokushesha kwe-Corticosteroid Dosage

Ungayeki ukusebenzisa i-systemic noma i-corticosteroid ehogelwe kungazelelwe lapho uqala ukwelashwa nge-TEZSPIRE. Ukunciphisa umthamo we-corticosteroid, uma kufanelekile, kufanele kube kancane kancane futhi kwenziwe ngaphansi kokuqondisa okuqondile kukadokotela. Ukwehliswa komthamo we-corticosteroid kungase kuhlotshaniswe nezimpawu zokuhoxa ezihleliwe kanye/noma izimo zokuqaqa ezazicindezelwe ngaphambilini i-systemic corticosteroid therapy.

I-Parasitic (Helminth) Ukutheleleka

Akwaziwa ukuthi i-TEZSPIRE izoba nomthelela yini ekuphenduleni kwesiguli ekuthelelekeni nge-helminth. Yelapha iziguli ezinezifo ze-helminth esezivele zikhona ngaphambi kokuqala ukwelashwa nge-TEZSPIRE. Uma iziguli zitheleleka ngesikhathi zithola i-TEZSPIRE futhi zingaphenduli ekwelashweni kwe-anti-helminth, yeka i-TEZSPIRE kuze kube yilapho ukutheleleka sekuphelile.

I-Live Attenuated Vaccines

Ukusetshenziswa kanyekanye kwe-TEZSPIRE kanye nemithi yokugoma enciphile akukahlolisiswa. Ukusetshenziswa kwemithi yokugoma ephila isikhathi eside kufanele kugwenywe ezigulini ezithola i-TEZSPIRE.

IZIPHENDULO EZIKHULULEKILE

Ukusabela okungavamile okuvame kakhulu (isigameko ≥3%) yi-pharyngitis, i-arthralgia, nobuhlungu beqolo.

SEBENZISA ABANTU ABAKHETHEKILE

Ayikho idatha etholakalayo ngokusetshenziswa kwe-TEZSPIRE kwabesifazane abakhulelwe ukuhlola noma iyiphi ingozi ehlobene nezidakamizwa yokukhubazeka okukhulu kokuzalwa, ukuphuphuma kwesisu, noma eminye imiphumela emibi kamama noma yengane. Ukudluliswa kwe-placenta kwama-antibodies e-monoclonal afana ne-Tezepelumab-ekko kukhulu phakathi ne-trimester yesithathu yokukhulelwa; ngakho-ke, imiphumela engaba khona ku-fetus kungenzeka ibe mikhulu phakathi ne-trimester yesithathu yokukhulelwa.

LOKHO ONGAKUTHATHE KULESI SIHLOKO:

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.