A FDA Avomereza Chithandizo Chatsopano Chowonjezera pa Chifuwa Choopsa

Tezspire idavomerezedwa kutsatira Kuunika Kwambiri Kwambiri ndi FDA komanso kutengera zotsatira za PATHFINDER pulogalamu yoyeserera yachipatala. Ntchitoyi idaphatikizanso zotsatira za mayeso ofunikira a NAVIGATOR Phase 3 pomwe Tezspire adawonetsa kupitilira muyeso uliwonse woyambira komanso wachiwiri kwa odwala omwe ali ndi mphumu yayikulu, poyerekeza ndi placebo, atawonjezeredwa ku chithandizo chokhazikika.

Tezspire ndi biologic yoyamba mu class biologic ya mphumu yoopsa yomwe imagwira pamwamba pa kutupa kwa kutupa poyang'ana thymic stromal lymphopoietin (TSLP), epithelial cytokine.3 Ndiwoyamba komanso biologic yokhayo yomwe imachepetsa nthawi zonse komanso kuchepetsa kuwonjezereka kwa mphumu kudutsa. Mayesero achipatala a Phase 2 ndi 3, omwe anali ndi anthu ambiri odwala mphumu mosasamala kanthu za zizindikiro zazikulu za biomarker, kuphatikizapo ma eosinophil a magazi, mawonekedwe a allergen ndi fractional exhaled nitric oxide (FeNO) . zomwe zilibe phenotype-eosinophilic kapena allergener-kapena biomarker malire mkati mwa chizindikiro chake chovomerezeka.

Zotsatira zochokera ku mayeso a NAVIGATOR Phase 3 zidasindikizidwa mu The New England Journal of Medicine mu Meyi 2021.2 M'maphunziro azachipatala a Tezspire, zoyipa zomwe zimachitika kwambiri zinali nasopharyngitis, matenda am'mimba komanso mutu.

Tezspire ikuwunikiranso ku EU, Japan ndi mayiko ena angapo padziko lonse lapansi.

Kudzipereka kwa Chithandizo cha Odwala

Amgen ndi AstraZeneca adzipereka kupereka odwala oyenerera omwe amapatsidwa Tezspire mwayi wopeza mankhwalawa. Odwala, osamalira ndi madokotala omwe amafunikira thandizo kapena zothandizira angathe kulumikizana ndi pulogalamu ya Tezspire Together kuyambira Lolemba, Dec. 20 pa 8: 00 am ET poyimba 1-888-TZSPIRE (1-888-897-7473).

Tezspire™ (tezepelumab-ekko) U.S. Chizindikiro

Tezspire ndi mankhwala amtundu woyamba omwe amasonyezedwa kuti awonjezere chithandizo cha odwala akuluakulu ndi ana azaka za 12 ndi kupitirira omwe ali ndi mphumu yoopsa.

Tezspire sichimasonyezedwa pofuna mpumulo wa bronchospasm kapena status asthmaticus.

Tezspire™ (tezepelumab-ekko) Zofunika Zachitetezo 

CONTRAINDICATIONS

Odziwika hypersensitivity kwa tezepelumab-ekko kapena excipients.

CHENJEZO NDI CHENJEZO

Zochita za Hypersensitivity

Zotsatira za hypersensitivity (mwachitsanzo, zotupa ndi matupi awo sagwirizana conjunctivitis) zitha kuchitika potsatira kuperekedwa kwa TEZSPIRE. Izi zitha kuchitika pakangotha ​​maola angapo mutalandira chithandizo, koma nthawi zina zimayamba mochedwa (ie, masiku). Pakachitika vuto la hypersensitivity, yambitsani chithandizo choyenera monga momwe zasonyezedwera kuchipatala ndiyeno ganizirani ubwino ndi zoopsa za wodwalayo kuti adziwe ngati apitirize kapena kusiya chithandizo ndi TEZSPIRE.

Zizindikiro Za mphumu Yambiri kapena Matenda Owonongeka

TEZSPIRE sayenera kugwiritsidwa ntchito pochiza zizindikiro za mphumu, kuwonjezereka kwakukulu, bronchospasm, kapena status asthmaticus.

Kuchepetsa Mwamsanga kwa Mlingo wa Corticosteroid

Musasiye kumwa mankhwala a corticosteroids mwadzidzidzi mukangoyamba kulandira chithandizo ndi TEZSPIRE. Kuchepetsa mlingo wa corticosteroid, ngati kuli koyenera, kuyenera kuchitidwa pang'onopang'ono ndikuyang'aniridwa ndi dokotala. Kuchepa kwa mlingo wa corticosteroid kumatha kulumikizidwa ndi zizindikiro zosiya kusuta komanso/kapena zodziwikiratu zomwe zidatsitsidwa kale ndi systemic corticosteroid therapy.

Matenda a Parasitic (Helminth).

Sizikudziwika ngati TEZSPIRE idzakhudza momwe wodwalayo amachitira ndi matenda a helminth. Chiritsani odwala omwe ali ndi matenda a helminth omwe analipo kale musanayambe chithandizo ndi TEZSPIRE. Ngati odwala atenga kachilombo pamene akulandira TEZSPIRE ndipo osayankha mankhwala odana ndi helminth, asiye TEZSPIRE mpaka matenda atatha.

Katemera Wamoyo Wocheperako

Kugwiritsiridwa ntchito limodzi kwa TEZSPIRE ndi katemera wocheperako sikunawunikidwe. Kugwiritsa ntchito katemera wocheperako kuyenera kupewedwa kwa odwala omwe amalandira TEZSPIRE.

ZOCHITIKA ZAMBIRI

Zomwe zimachitika kwambiri (zochitika ≥3%) ndi pharyngitis, arthralgia, ndi ululu wammbuyo.

MUZIGWIRITSA NTCHITO ANTHU ENA

Palibe deta yomwe ilipo pakugwiritsa ntchito TEZSPIRE kwa amayi apakati kuti awone ngati pali chiopsezo chilichonse chokhudzana ndi mankhwala okhudzana ndi kubadwa kwakukulu, kupititsa padera, kapena zotsatira zina zoipa za amayi kapena mwana. Kutumiza kwa placenta kwa ma antibodies a monoclonal monga Tezepelumab-ekko ndi aakulu pa trimester yachitatu ya mimba; Choncho, zotsatira zomwe zingatheke pa mwana wosabadwa zimakhala zazikulu kwambiri m'kati mwa trimester yachitatu ya mimba.