I-Tezspire yamkelwa ngokulandela uPhononongo oluPhambili yi-FDA kwaye isekelwe kwiziphumo ezivela kwi-PATHFINDER inkqubo yovavanyo lweklinikhi. Isicelo sibandakanya iziphumo ezivela kwi-NAVIGATOR yeSigaba se-3 esibalulekileyo apho i-Tezspire ibonise ukuphakama kuyo yonke into ephambili kunye neyokugqibela yesibini kwizigulane ezine-asthma enzima, xa kuthelekiswa ne-placebo, xa yongezwa kunyango oluqhelekileyo.

I-Tezspire yi-biologic yokuqala ye-biologic ye-asthma enzima eyenza phezulu kwi-cascade evuthayo ngokujolisa i-thymic stromal lymphopoietin (TSLP), i-epithelial cytokine.3 Yeyokuqala kunye ne-biologic kuphela yokunciphisa ngokuqhubekayo kunye nokunciphisa kakhulu ukunyuka kwe-asthma kuyo yonke indawo. Isigaba se-2 kunye ne-3 yezilingo zeklinikhi, ezibandakanya inani elibanzi lezigulane ze-asthma ezinzima kungakhathaliseki ukuba zeziphi iimpawu ze-biomarker eziphambili, kubandakanywa izibalo ze-eosinophil zegazi, isimo se-allergic kunye ne-fractional exhaled nitric oxide (FeNO) . engenayo i-phenotype-eosinophilic okanye i-allergic-okanye umda we-biomarker ngaphakathi kweleyibhile evunyiweyo.

Iziphumo ezivela kulingo lwe-NAVIGATOR yeSigaba se-3 zapapashwa kwi-New England Journal of Medicine ngoMeyi 2021.2 Kwizifundo zeklinikhi zeTezspire, ezona ziphumo zixhaphakileyo zixhaphakileyo yi-nasopharyngitis, usulelo lwendlela yokuphefumula ephezulu kunye nentloko.

I-Tezspire iphantsi kovavanyo lolawulo kwi-EU, eJapan nakwamanye amazwe amaninzi kwihlabathi liphela.

Ukuzibophelela kwiNkxaso yesigulane

I-Amgen kunye ne-AstraZeneca bazibophelele ekuboneleleni izigulane ezifanelekileyo ezimiselwe iTezspire ngokufikeleleka kwiyeza. Izigulane, abanakekeli kunye noogqirha abafuna inkxaso okanye izibonelelo banokuqhagamshelana neprogram yeTezspire Together eqala ngoMvulo, i-Dec. 20 ngo-8: 00 am ET ngokubiza i-1-888-TZSPIRE (1-888-897-7473).

I-Tezspire™ (tezepelumab-ekko) Isalathiso sase-US

I-Tezspire liyeza lokuqala kwiklasi eliboniswe ukongezwa kwonyango lokugcinwa kwabantu abadala kunye nabantwana abaneminyaka eyi-12 ubudala nangaphezulu abane-asthma enzima.

I-Tezspire ayiboniswanga ukukhululeka kwe-bronchospasm ebukhali okanye isimo se-asthmaticus.

Tezspire™ (tezepelumab-ekko) Ulwazi oluBalulekileyo ngoKhuseleko

IIMISEBENZI

I-hypersensitivity eyaziwayo kwi-tezepelumab-ekko okanye i-excipients.

Izilumkiso kunye namanyathelo

Iimpendulo ze-hypersensitivity

Ukusabela kwe-hypersensitivity (umzekelo, i-rash kunye ne-conjunctivitis ye-allergic) ingenzeka emva kokulawulwa kwe-TEZSPIRE. Ezi ntshukumo zinokwenzeka kwiiyure zolawulo, kodwa kwezinye iimeko ziqala ukulibaziseka (okt, iintsuku). Kwimeko ye-hypersensitivity reaction, qalisa unyango olufanelekileyo njengoko kubonisiwe kliniki kwaye emva koko ucinge ngeenzuzo kunye nobungozi kwisigulane ngasinye ukugqiba ukuba ngaba ukuqhubeka okanye ukuyeka unyango nge-TEZSPIRE.

Iimpawu ze-Asma eziAcute okanye izifo eziya ziba mandundu

I-TEZSPIRE ayifanele isetyenziswe ukunyanga iimpawu ze-asthma ezibukhali, ukunyanzeliswa kwe-acute, i-bronchospasm, okanye i-asthmaticus.

UkuNcitshiswa ngokukhawuleza kwe-Corticosteroid Dosage

Musa ukuyeka ukusebenzisa i-systemic okanye i-corticosteroids ephefumle ngokukhawuleza xa uqaliswa ngonyango nge-TEZSPIRE. Ukunciphisa umthamo we-corticosteroid, ukuba kufanelekile, kufuneka kube ngokuthe ngcembe kwaye kwenziwe phantsi kweliso elithe ngqo likagqirha. Ukuncitshiswa kwedosi ye-corticosteroid kunokunxulunyaniswa neempawu zokurhoxiswa kwenkqubo kunye/okanye ukutyhila iimeko ebezicinezelwe ngaphambili lunyango lwe-systemic corticosteroid.

Usulelo lweParasitic (Helminth).

Akwaziwa ukuba i-TEZSPIRE iyakuchaphazela impendulo yesigulane ngokuchasene nosulelo lwe-helminth. Nyanga izigulane ezinosulelo lwe-helminth esele lukhona phambi kokuba uqalise unyango nge-TEZSPIRE. Ukuba izigulane zosuleleka ngelixa zifumana i-TEZSPIRE kwaye zingaphenduli kunyango lwe-anti-helminth, yeka i-TEZSPIRE de usulelo lusonjululwe.

Live Attenuated vaccines

Ukusetyenziswa ngaxeshanye kwe-TEZSPIRE kunye nezitofu zokugonya ezinciphileyo ayikavavanywa. Ukusetyenziswa kwezitofu zokugonya eziphilayo kufuneka kuthintelwe kwizigulana ezifumana i-TEZSPIRE.

IZIPHUMO EZIBONAKALAYO

Iimpendulo ezixhaphakileyo ezixhaphakileyo (iziganeko ≥3%) yi-pharyngitis, i-arthralgia, kunye neentlungu zangasemva.

UKUSETYENZISWA KWABANTU ABAKHETHEKILEYO

Akukho datha ekhoyo kwi-TEZSPIRE yokusetyenziswa kwabasetyhini abakhulelweyo ukuvavanya nayiphi na ingozi enxulumene neziyobisi yeziphene ezinkulu zokuzalwa, ukuphuphuma kwesisu, okanye ezinye iziphumo ezibi zomama okanye zomntwana. Ukudluliselwa kwe-placental ye-antibodies ye-monoclonal efana ne-Tezepelumab-ekko inkulu ngexesha le-trimester yesithathu yokukhulelwa; ke ngoko, iziphumo ezinokuthi zibe kho kwimveku engekazalwa zinokuba nkulu ngexesha lekota yesithathu yokukhulelwa.

INTO ONOKUYITHATHA KWELI NQAKU:

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.