Tobetsa mona ho bonts'a lifolakha tsa HAO leqepheng lena mme u lefelle katleho feela

Litaba tsa mohala

FDA e Amohela Kalafo e Ncha ea Keketso Bakeng sa Asma e Matla

ngotsoeng ke mohlophisi

Kajeno Amgen e phatlalalitse hore Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) e amohetse Tezspire™ (tezepelumab-ekko) ea Amgen le AstraZeneca bakeng sa kalafo ea tlatsetso ea bakuli ba baholo le bana ba lilemo tse 12 ho ea holimo ba nang le asthma e matla.

Tezspire e amohetsoe ka mor'a Tlhahlobo ea Bohlokoa ke FDA mme e ipapisitse le liphetho ho tsoa lenaneong la teko ea bongaka ea PATHFINDER. Kopo e kenyelelitse liphetho tse tsoang tekong ea bohlokoa ea NAVIGATOR Phase 3 moo Tezspire e bonts'itseng bophahamo holima ntlha e 'ngoe le e 'ngoe ea mantlha le ea mantlha ho bakuli ba nang le asthma e matla, ha e bapisoa le placebo, ha e eketsoa kalafong e tloaelehileng.

Tezspire ke biologic ea pele-in-class biologic bakeng sa asthma e matla e sebetsang ka holimo ho inflammatory cascade ka ho lebisa tlhokomelo ea thymic stromal lymphopoietin (TSLP), epithelial cytokine.3 Ke eona ea pele le e le 'ngoe feela ea biologic ho fokotsa ka mokhoa o tsitsitseng le haholo ho fokotsa ho mpefala ha asthma ho pholletsa le Liteko tsa kliniki tsa Phase 2 le 3, tse neng li kenyelletsa palo e pharaletseng ea bakuli ba asthma e matla ho sa tsotellehe li-biomarker tsa bohlokoa, ho kenyelletsa le lipalo tsa mali a eosinophil, boemo ba allergic le fractional exhaled nitric oxide (FeNO) .2,3 Tezspire ke eona ea pele le ea biologic feela bakeng sa asthma e matla. e se nang phenotype-eosinophilic kapa allergic-kapa biomarker limiter ka har'a label e amohelehang.

Liphetho ho tsoa tekong ea NAVIGATOR Phase 3 li phatlalalitsoe ho The New England Journal of Medicine ka Mots'eanong 2021.2 Lithutong tsa bongaka tsa Tezspire, litlamorao tse mpe tse atileng haholo e ne e le nasopharyngitis, ts'oaetso ea phefumoloho e kaholimo le hlooho.

Tezspire e tlas'a tlhahlobo ea taolo ho EU, Japane le linaheng tse ling tse 'maloa ho pota lefatše.

Boitlamo ho Tšehetso ea Bakuli

Amgen le AstraZeneca li ikemiselitse ho fa bakuli ba loketseng ba laetsoeng Tezspire monyetla oa ho fumana meriana ka theko e tlase. Bakuli, bahlokomeli le lingaka tse hlokang tšehetso kapa lisebelisoa ba ka ikopanya le lenaneo la Tezspire Together ho qala ka Mantaha, Dec. 20 ka 8:00 am ET ka ho letsetsa 1-888-TZSPIRE (1-888-897-7473).

Tezspire™ (tezepelumab-ekko) US Indication

Tezspire ke moriana oa boemo ba pele o bontšitsoeng bakeng sa kalafo ea tlatsetso ea bakuli ba batho ba baholo le bana ba lilemo tse 12 ho ea holimo ba nang le asthma e matla.

Tezspire ha e bontšoe bakeng sa phomolo ea bronchospasm e matla kapa boemo ba asthmaticus.

Tezspire™ (tezepelumab-ekko) Lintlha tsa Bohlokoa tsa Tšireletseho 

TLHOKOMELISO

Tse tsejoang ke hypersensitivity ho tezepelumab-ekko kapa li-excipients.

LEMOSO LE LITLOKO

Karabelo ea Hypersensitivity

Karabelo ea hypersensitivity (mohlala, rash le allergic conjunctivitis) e ka hlaha kamora ho tsamaisoa ha TEZSPIRE. Maikutlo ana a ka hlaha ka mor'a lihora tse 'maloa ka mor'a tsamaiso, empa maemong a mang a lieha ho qala (ke hore, matsatsi). Ha ho e-na le maikutlo a hypersensitivity, qala phekolo e nepahetseng joalokaha ho boletsoe ke tleliniki ebe u nahana ka melemo le likotsi tsa mokuli ka bomong ho etsa qeto ea hore na a tsoele pele kapa a khaotse ho phekoloa ka TEZSPIRE.

Matšoao a Asma a Haholo kapa Mafu a Senyehileng

TEZSPIRE ha ea lokela ho sebelisoa ho phekola matšoao a asthma a hlobaetsang, ho mpefala ho matla, bronchospasm e matla, kapa boemo ba asthmaticus.

Phokotso e potlakileng ea tekanyo ea Corticosteroid

U se ke ua khaotsa ho sebelisa corticosteroids ea tsamaiso kapa ea ho hema hang-hang ha u qala kalafo ka TEZSPIRE. Ho fokotseha ha tekanyo ea corticosteroid, haeba ho loketse, ho lokela ho etsoa butle-butle le ho etsoa tlas'a tlhokomelo e tobileng ea ngaka. Phokotso ea lethal dose ea corticosteroid e ka amahanngoa le matšoao a ho ikhula le/kapa maemo a pepenene a neng a hateletsoe pele ke systemic corticosteroid therapy.

Tšoaetso ea Parasitic (Helminth).

Ha ho tsejoe hore na TEZSPIRE e tla susumetsa karabelo ea mokuli khahlanong le tšoaetso ea helminth. Phekola bakuli ba nang le tšoaetso ea helminth e seng e le teng pele u qala kalafo ka TEZSPIRE. Haeba bakuli ba tšoaelitsoe ha ba ntse ba amohela TEZSPIRE 'me ba sa arabele kalafo ea anti-helminth, tlohela TEZSPIRE ho fihlela tšoaetso e rarolla.

Live Attenuated ente

Tšebeliso ea nako e le 'ngoe ea TEZSPIRE le liente tse fokolang tse phelang ha e so hlahlojoe. Tšebeliso ea liente tse fokolisitsoeng tse phelang e lokela ho qojoa ho bakuli ba fumanang TEZSPIRE.

LIEKETSO MATSOSO

Litlamorao tse mpe tse atileng haholo (ketsahalo ≥3%) ke pharyngitis, arthralgia le bohloko ba mokokotlo.

SEBELISA BATHO BA KHETHEHILENG

Ha ho na lintlha tse teng mabapi le tšebeliso ea TEZSPIRE ho bakhachane ho hlahloba kotsi leha e le efe e amanang le lithethefatsi ea bokooa bo boholo ba tsoalo, ho senyeheloa ke mpa, kapa liphello tse ling tse mpe tsa 'mè kapa lesea. Ho fetisoa ha placenta ea li-antibodies tsa monoclonal tse kang Tezepelumab-ekko e kholoanyane nakong ea boraro ea bokhachane; ka hona, liphello tse ka bang teng ho lesea le ka pōpelong li ka 'na tsa e-ba kholoanyane nakong ea trimester ea boraro ea bokhachane.

Litaba Tse Amanang

Mabapi le mongoli

mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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