Amjevita (adalimumab-atto), biosimilar ku jirta Humira (adalimumab) , ayaa waxaa ansixiyay FDA ee loo yaqaan ' rheumatoid arthritis-ka' iyo cudurro kala duwan oo bararsan. Amjevita wuxuu noqday midka afaraad ee loo yaqaan 'biosimilar' si uu u ansixiyo FDA. Biosimilars, taariikhda ansixinta FDA, waa:
- Zarxio (filgrastim-sndz) - Maarso 6, 2015
- Inflectra ( Infliximab -dyyb) - Abriil 5, 2016
- Erelzi (soogalootiga) - August 30, 2016
- Amjevita (adalimumab-atto) - Sebtember 23, 2016
Zarxio, si ka duwan kuwa kale, laguma tilmaamayo cudurada rheumatic , laakiin halkii ay ka mid tahay arinta koritaanka leukocyte. Inflectra waa biosimilar oo loo yaqaan Remicade (Infliximab) . Erelzi waa biosimilar loo gooyo Enbrel (etanercept) . Enbrel, Remicade, iyo Humira waa daawooyinka bayoolajiga ah , oo lagu tilmaamay inay yihiin TNF Blockers .
Tilmaamaha Amjevita
Amjevita waxaa loogu talagalay daaweynta:
- Rheumatoid Arthritis - Si loo yareeyo calaamadaha iyo astaamaha, waxay xakameysaa horumarka dhismaha, iyo wanaajinta howlaha jireed ee dadka qaangaarka ah ee leh rheumatoid arthritis-dhexdhexaad ah oo firfircoon.
- Si loo yareeyo calaamadaha iyo astaamaha JIA-da ee dhexdhexaad ah iyo kuwo aad u firfircoon ee JIA ee carruurta 4 sano jira ama ka weyn.
- Si loo yareeyo calaamadaha iyo astaamaha, in la xakameeyo horumarka dhismaha, iyo wanaajinta howlaha jireed ee dadka qaangaarka ah ee leh cudurka "psoriasis arthritis".
- Ankylosing Spondylitis - Si loo yareeyo calaamadaha iyo calaamadaha dadka qaangaarka ah ee leh xajiin ankylosing spondylitis.
- Si loo yareeyo calaamadaha iyo calaamadaha; si loo soo jiido loona ilaaliyo cafimaadka bukaanka ee dadka qaangaarka ah ee leh cudurrada Crohnka oo si dhexdhexaad ah ufilmaamaya oo aan ku filneyn jawaab celinta daaweynta caadiga ah, ama lumay jawaabtooda Qaadista, ama aan u dulqaadan karin Remicade.
- Cudurka Buufiska - Si loo yareeyo loona ilaaliyo xanuunka bukaan-socodka ee dadka qaangaarka leh colitis dhexe ama mid firfircoon oo firfircoon oo leh jawaab aan ku filnayn oo ku saabsan difaac-darrada.
- Plaque Psoriasis - Dadka qaangaarka ah ee qaba cudurka psoriasis ee dhexdhexaad ah ilaa daran oo ku habboon musharraxda daaweynta nidaamsan ama daweyn daweyneed; sidoo kale, marka dawooyinka kale ee nidaamyada loo arko inaysan habboonayn.
Miisaanka iyo Maamulka
Amjevita waxaa maamula duritaanka subcutaneous. Waxaa la heli karaa sida 40 mg / 0.8mL ee qiyaasta isticmaalka keli ah ee SureClick autoinjector, maaddaama 40 mg / 0.8 mL qiyaasta isticmaalka sirinjirta mudnaanta leh, iyo 20 mg / 0.4 mL oo ah muraayad horay loo isticmaalo syringe.
Qiyaasta lagu taliyey ee Amjevita ee rheumatoid arthritis, cudurka psoriasis arthritis, iyo ankylosing spondylitis waa 40 mg toddobaadkii kasta. Haddii aad qabtid rheumatoid arthritis-ka iyo aadan qaadan daawada methotrexate , qiyaasta daawada badan ee 40 mg toddobaad walba waa la tixgelin karaa.
Carruurta miisaankoodu u dhaxeeyo 33 rodol iyo 65 rodol, qiyaasta lagu taliyey ee Amjevita waa 20 mg. toddobaad kasta oo kale. Qiyaasta carruurta ee miisaanka 66 rodol ama ka badan waa 40 mg. toddobaad kasta oo kale.
Cudurka cudurrada Crohn iyo colitis sambabada, Maalinta 1aad ee daweynta Amjevita, qiyaasta waa 160 mg.
(xusuusnow: waxaa laga yaabaa in loo qeybiyo 80 mg laba maalmood oo isku xiga, Maalinta 15aad, qiyaasta qiyaasta 80 mg, iyo Maalinta 29aad, waxaad billaabaysaa qiyaasta dayactir ah ee 40 mg Toddobaad kasta gudaheeda Dadka qaba cudurka psoriasis , qiyaasta bilawga ah waa 80 mg, ka dibna usbuuca ka dambeeya qiyaasta bilowga, qiyaasta daaweynta waa 40 mg todobaad kasta.
Waxyeellooyinka, Dhibaatooyinka Dhibaatooyinka ah, iyo Contraindications
Dareen-celinnada guud ee la xidhiidha Amjevita waxaa ka mid ah caabuq (sida sinusitis ama infakshanka neef-mareenka sare), fal-celinta goobta duritaanka, madax-xanuun, iyo firiiric. Ma jiraan wax khilaaf ah oo ku qoran liiska qorista ee Amjevita.
Digniinta iyo Taxaddarrada
Amjevita waxay la timaaddaa digniinta Black Box, digniinta ugu weyn ee ay soo saartay FDA.
Digniinta sanduuqa madow ee loogu talagalay waa cudurro halis ah iyo uur qaadid. Amjevita wuxuu ku xiran yahay khatarta sii kordheysa ee caabuqa halista ah, taas oo keeni karta isbitaal dhigis ama dhimasho, oo ay ku jiraan qaaxada (tuberculosis), bakteeriyada sepsis, infakshanka fungal-ka (tusaale, histoplasmosis), iyo infekshannada ay keenaan jirrooyinka fursadaha. Digniinta digniinta sidoo kale waxay kugula talinaysaa joojinta Amjevita haddii caabuq daran ama sepsis uu ku dhaco inta lagu jiro daaweynta. Baaritaanka qaaxada qarsoon waxaa lagula talinayaa kahor inta aan la bilaabin daaweynta Amjevita. Sidoo kale, kuwa lagu daaweeyo Amjevita waa in la ilaaliyaa qaaxada firfircoon, xitaa haddii baaritaanka qaaxada ee qarsooni ay tahay mid xun.
Marka la eego digniinta kansarka, waxaa jiray warbixino sheegaya lymphoma iyo malignancies (qaar ka mid ah kuwaa oo ay u dhinteen) carruurta iyo dhallinyarada qaangaarka ah ee lagu daweeyo TNF-blockers. Sidoo kale, waxaa jirey warbixinno dib-u-kicin ah oo ku saabsan nooca nudaha T-cell, oo loo yaqaan 'HSTCL (hepatosplenic T-cell lymphoma), qaangaarka iyo dhalinyarada qaangaarka leh ee caabuqa caabuqa ee lagu daweeyo TNF-blockers.
Digniino badan ayaa lagu soo bandhigay warbixinta qoritaanka:
- Waa inaadan bilaabin Amjevita inta lagu jiro infekshanka firfircoon.
- Amjevita waa in la joojiyaa haddii cudurku noqdo mid halis ah.
- Daaweynta anti-fungal waa in loo tixgeliyaa dadka qaata jirro nidaam ah marka lagu daaweeyo Amjevita waxayna ku noolaadaan ama u safraan gobollada halka infekshanka fangasku ay ku dhammaadaan.
- Dareen-celinta xasaasiyadda ama anaphylaxis waxay ku dhici kartaa Amjevita.
- Dib-u-qabashada cagaarshow B ayaa dhici karta marka la daaweeyo Amjevita. Kontoroolayaasha HBV waa in la ilaaliyaa.
- Cunto cusub oo cusub ama ka sii daraysa cudurka neefsashada ayaa laga yaabaa inuu ku dhaco Amjevita.
- Ciladaha dhiigga ayaa dhici kara, oo ay ku jiraan cytopenias (tirada unugyada unugyada dhiigga yar) iyo pancytopenia (tirada yar ee unugyada dhiigga cas, unugyada dhiigga cad, iyo tarataraha).
- Bilawga cusub ama sii xumaanaya wadnaha wadnaha ayaa dhici karta marka la daaweeyo Amjevita.
- Lupus-like syndrome ayaa laga yaabaa inay kobcaan marka lagu daaweeyo Amjevita, oo u baahan in la joojiyo.
Isdhexgalka daroogada
Waxaa jira halis dheeraad ah ee cudurada halista ah ee isku dhafan ee TNF-blockers iyo Kineret (anakinra) ama Orencia (abatacept) . Sidaa darteed, Amjevita waa in aan loo isticmaalin anakinra ama abatacept. Sidoo kale, talaalka nool waa in laga fogaadaa isticmaalka Amjevita.
Khadadka hoose
Biosimilar waxay heshaa oggolaansho ku saleysan caddaynta taageereysa in daroogadu ay "aad u egtahay" daroogo hore loo oggolaaday, oo loo yaqaano daroogada tixraaca. Oggolaansho ah oo la isku qurxiyo oo aan jirin wax farqi u leh kiliinikada u dhexeeya biosimilar iyo daroogada tixraaca ah.
Taasi waxay tidhi, waxaa jiray jahwareer iyo suaalo su'aalo ah oo ku hareeraysan fikradda biosimilars, xitaa ka hor intaan la oggolaan. Ma jiri karaa 100 boqolkiiba hubin in biosimilar iyo daroogada tixraaca ay u dhigantaa? Ujeedooyinka qoritaanka, waa biosimilar oo la beddeli karo daroogada tixraaca? Shirkadaha caymiska ma ku qasban yihiin isticmaalka biosimilar sababtoo ah kharashka yar?
Kuwani waa su'aalo aad uwanaagsan waxayna joogaan su'aalo. Inkastoo biosimilar laga yaabo in si macquul ah loo qoro bukaanka cusub ee la ogaado, ma caqli maaha in laga sugo bukaanka si fiican u shaqeynaya bayoolojiga si uu u bedelo biosimilar?
Dhamaadkii 2016, waxaa jirey billow jilicsan oo ah Inflectra. Erelzi ma bilaabi doono ka hor 2018 maadaama uu ku xiran yahay dagaal qarsoodi ah Amgen. Isbedelka dhabta ah ee biosimilar iyo daawooyinkooda tixraaca ayaa wali aan la dhicin habka ka baxa bukaanka iyo dhakhaatiirta kalsooni buuxda. Waxaa laga yaabaa in waqtigaa, tani bedeli doonto. Dhanka kale, kala hadal dhakhtarkaaga si aad u aragtid xalka ugu fiican ee adiga kugu habboon.
> Ilo:
> Amjevita. Macluumaadka Qorista. Amgen. La rogay 9/2016.
> Palmer, Eric. > Madaxa Sandoz: Enbrel biosimilar Erelzi ma bilaabi doonto ka hor 2018, dib u dhac ku yimid dagaal sharci . > FiercePharma. Janaayo 25, 2017.
> Shaw, Gina. Biosimilar Infliximab waxay qaadataa tallaabooyin taxadar leh Suuqa. Farmashiyaha Gaarka ah. Janaayo 23, 2017.