I-FDA ivuma kuqala i-Eliquis generic: apixaban

Izindaba

Iziguli ezisengozini enkulu yokushaywa unhlangothi, i-pulmonary embolism (PE), ne-deep vein thrombosis (i-DVT) kungekudala zizoba nenketho entsha ejwayelekile yokuncipha kwegazi. NgoDisemba 23, i-U.S. Food and Drug Administration (FDA) kuvunyelwe izicelo ezimbili zemvelo yokuqala ye- U-Eliquis (apixaban) amaphilisi.

Uyini u-Eliquis?

U-Eliquis unegazi elincane, kusho Nonye Uddoh , Pharm.D., Usokhemisi wasemtholampilo ne-UnitedHealth Group, eSilver Spring, eMaryland. Isebenza ngokuvimba iphrotheyini yokujiya ebizwa ngokuthi yiFactor Xa. I-Factor Xa ingesinye sezici ezijiyisayo egazini lethu.

Umuthi wegama lomuthi wawungu- yavunywa okokuqala yi-FDA ngo-2012 ukuthi yenziwe yiBristol-Myers Squibb futhi ithengiswe yiPfizer. Ngaleso sikhathi, lo muthi wawulindelwe kakhulu ngongoti bezenhliziyo ababethokozile ngamandla ayo okusiza iziguli ezinengozi ethile yokuvala igazi. U-Eliquis wayeyi-anticoagulant yomlomo yesithathu (igazi elinciphile) ukuthola imvume ye-FDA. Kodwa-ke, lokhu kungukuvunyelwa kokuqala kwe-ejensi kwe-Eliquis generic.

Ama-anticoagulants womlomo aqondile afana no-Eliquis athathe indawo enkulu yomuthi obizwa ngokuthi I-Coumadin (warfarin) , ukwelashwa okudala okudinga ukuqashelwa ngokucophelela futhi kunokuxhumana okuningi okungenzeka kube kubi kwezidakamizwa. Iziguli ezithatha i-Eliquis azidingi ukuhlolwa kwegazi okuphindaphindiwe, okwenza ukwelashwa kufinyeleleke kalula kubantu abaningi.IXarelto kungenye indlela entsha futhi edumile ye-Eliquis.

OKUSHIWO: I-Eliquis vs. Xarelto

Yiziphi izimo zokuvala igazi ezenziwa ngu-Eliquis?

Ngokusho kwe-FDA , odokotela bangahle banikeze u-Eliquis ngezizathu ezilandelayo:

• Ukwehlisa ubungozi bokushaywa unhlangothi nokuqina kwesistimu ezigulini ezine-nonvalvular atrial fibrillation.
• Ukuvimbela i-vein thrombosis (i-DVT) ejulile emilenzeni, engaholela embolism ye-pulmonary embolism (PE) emaphashini ezigulini ezenze i-hip noma idolo lokuhlinzwa.
• Ukwelapha i-DVT ne-PE nokunciphisa ubungozi be-DVT ephindaphindekayo ne-PE kulandela ukwelashwa kokuqala.

Zonke lezi zimo ziyingozi — ngisho zisongela impilo — futhi zonke zibandakanya amahlule egazi.

Ukushaywa unhlangothi kwenzeka lapho kunehlule legazi ebuchosheni elivimba ukuhamba komoya-mpilo kuya kumaseli obuchopho, kusho uDkt Uddoh. Ukuhlanganiswa komzimba okuhleliwe kubangelwa ukuthuthukiswa kwamahlule egazini emithanjeni ejulile yemilenze (ebizwa nge-DVT) noma emaphashini (abizwa nge-PE).

I-DVT kubangela ubuhlungu nokuvuvukala emlenzeni eduze kwegazi. Uma ishiywe ingalashwa, ihlule legazi lingahambela emaphashini, lidale i-PE. Lesi yisimo esibi kakhulu esifaka phakathi izimpawu ezifana nobuhlungu besifuba, obungahle bube bucayi uma uphefumula kakhulu noma ukhwehlela, isiyezi, ukuquleka, ukukhwehlela igazi, ukuphefumula okungajulile, ukushaya kwenhliziyo okusheshayo noma okungajwayelekile, nokuphefumula okuncane.

I-Atrial fibrillation kanye nokuhlinzwa okuhlanganyelwe kokufaka okunye kwandisa ingozi yokushaywa unhlangothi, i-DVT, ne-PE. U-Eliquis, kanye no-Eliquis generic, bangehlisa leyo ngozi.

OKUhlobene : Ngabe kufanele uthathe izinciphisi zegazi ze-AFib?

Umthatha kanjani u-Eliquis?

Ngokusho kwe- umkhiqizi , I-Eliquis ithathwa njenge-2.5 noma i-5 mg tablet ngomlomo kabili ngosuku.

Kubiza malini u-Eliquis?

Iziguli zingathenga iphakethe lokuqalisa ngokunikezwa kwenyanga eyodwa kwe-Eliquis cishe ngama- $ 531, kuya ngokuthi iliphi ikhemisi elisebenzisayo. Kodwa-ke, umshwalense uvame ukumboza iningi laleyo ntengo. Iziguli ezinomshuwalense wezohwebo zivame ukukhokha cishe ama- $ 43 ngenyanga. Izinhlelo zeMedicare Part D kanye neMedicare Advantage nazo zimboza i-Eliquis, zehlisa intengo ibe ngu- $ 19 kuphela kumakhasimende athile.

Izotholakala nini i-Eliquis ejwayelekile ukuze ithengwe?

Ukuvunyelwa okujwayelekile kwe-FDA kuka-Eliquis (apixaban) kuya ezinkampanini ezimbili zemithi: iMicrosoft Labs Limited neMylan Pharmaceuticals, Inc. Kodwa-ke, lezi zinkampani ezimbili azikamemezeli ukuthi ukuthengiswa kwe-U.S. Intengo ejwayelekile ayikatholakali.