Amjevita (adalimumab-atto), iyo biosimilar kune Humira (adalimumab) , yakagamuchirwa neDDA nokuda kwehutatoid arthritis uye zvirwere zvakasiyana-siyana zvinoputira. Amjevita yakazova yechina biosimilar yekugamuchirwa neDFA. Izvo zvinonzi biosimilars, pamwe nezuva rekubvumirwa kwavo kwe FDA, ndezvi:
- Zarxio (filgrastim-sndz) - March 6, 2015
- Inflectra (infliximab-dyyb) - April 5, 2016
- Erelzi (etanercept-szzs) - August 30, 2016
- Amjevita (adalimumab-atto) - September 23, 2016
Zarxio, kusiyana nemamwe, haarati anoratidzirwa nezvirwere zverheumatic , asi pane iyo iroukocyte kukura. Inflectra ndiyo biosimilar kuna Remicade (infliximab) . Erelzi ndiyo biosimilar kune Enbrel (etanercept) . Enbrel, Remicade, uye Humira ndezvimwe zvinonzi biologic zvinodhaka , zvinorondedzerwa seTNF blockers .
Zviratidzo zveAmjevita
Amjevita inoratidzwa mukurapa kwe:
- Rheumatoid Arthritis - Kuti kuderedza zviratidzo uye zviratidzo, zvinodzivisa kufambira mberi kwehutano hwemuitiro, uye kuvandudza basa remuviri kune vanhu vakuru vane mwero kuti vaite zvakanyanya rheumatoid arthritis.
- Juvenile Idiopathic Arthritis (JIA) - Kuti kuderedza zviratidzo uye zviratidzo zvepamwero kuti zvive zvakaoma kuratidzira polyarticular JIA mune vana makore emakore kana kupfuura.
- Psoriatic Arthritis - Kuti kuderedza zviratidzo uye zviratidzo, zvinodzivisa kufambira mberi kwehutano hwemuitiro, uye kuvandudza basa remuviri kune vanhu vakuru vane active psoriatic arthritis.
- Ankylosing Spondylitis - Kuti kuderedza zviratidzo uye zviratidzo kune vanhu vakuru vane kushanda ankylosing spondylitis.
- Dhiyabhorosi yeChristin - Kuti kuderedza zviratidzo nezviratidzo; kuedza uye kuchengeta kuregererwa kwekliniki muvanhu vakuru vane chimiro kusvika kune chirwere cheCrohn chinoshingaira chakange chisina kukodzera kugadziriswa kuratidzira, kana kukanganisa kupindura kwavo kuna Remicade, kana kuti haigone kuregerera Remicade.
- Ulcerative Colitis - Kukurudzira nekuchengetedza kukanganiswa kwekliniki mune vanhu vakuru vane mwero kana kuti zvakanyanya kushanda kwepachirwere chirwere chinenge chisina kukodzera kugadzirisa zvirwere zvekudzivirira muviri.
- Plaque Psoriasis - Kuvanhu vakuru vane mwero wakakura kusvika kune wakakura chronic plaque psoriasis avo vakakodzera kutsvaga chirongwa chekugadzira chirongwa kana phototherapy; zvakare, apo mamwe maitiro ehutachiona anonzi haana kukodzera.
Yakarongedzerwa Dosage uye Administration
Amjevita inotungamirirwa nejasi remajekiti. Inowanikwa se 40 mg / 0.8 mL dose mune imwe chete-shandiswa yakagadzirwa SureClick autoinjector, se 40 mg / 0.8 mL murasi mune imwe chete inoshandisa shanduro yeglasi yakagadzirwa, uye 20 mg / 0.4 mL mune rimwe chete rinoshandiswa girazi sirindi.
Nhamba yakakurudzirwa yeAmjevita ye rheumatoid arthritis, psoriatic arthritis, uye ankylosing spondylitis 40 mg imwe neimwe yevhiki. Kana uine rheumatoid arthritis uye usatora methotrexate , chirwere chinowanzoita 40 mg vhiki imwe neimwe chingafungidzirwa.
Kune vana vanoyerera pakati pemakiromita makumi matatu nemazana matanhatu nemapirogiramu, chirongwa chinorayirwa cheAmjevita chine 20 mg. imwe neimwe vhiki. Chirwere chevana vanoyera mapaundi 66 kana kupfuura nde 40 mg. imwe neimwe vhiki.
Kune Crohn's disease uye ulcerative colitis, paZuva 1 rekurapa neAmjevita, iyo inonzi 160 mg.
(cherechedzai: inogona kugoverwa kuva 80 mg kupfuura kwemazuva maviri akaitevera: musi wa15, iyo inonzi 80 mg; uye musi we29, iwe unotanga chirongwa chekuchengetedza che 40 mg imwe neimwe yevhiki.Kana vanhu vane psoriasis , chiyero chokutanga chinenge 80 mg uye uye vhiki imwe inotevera chiyero chekutanga, chirwere chekuchengetedza chiri 40 mg imwe neimwe yevhiki.
Migumisiro Yechipfuva, Kusarudzo Kwakashata, uye Contraindications
Kukanganisa kwakajairika kunowanzobatanidzwa neAmjevita kunosanganisira zvirwere (zvakadai se sinusitis kana kuputika kwepamusoro zvirwere), kupindira kwemajw.org, kuora musoro, nekukurumidza. Izvo hazvina zvinyorwa zvinyorwa zvakanyorwa muzvinyorwa zveAmjevita.
Manyevero uye Kuchengetedza
Amjevita inouya neBlack Box Warning, nyevero yakakomba yakabudiswa neDFA.
Iyo yebhokisi bhokisi inonyeverwa ndeyekutapukisa kwakakomba uye kwekutadza. Kunyanya zvakanyanya, Amjevita inobatanidza nehuwandu hwehutachiona hutachiona hunogona kutungamirira kuchipatara kana kufa, kusanganisira TB (tuberculosis), sepisteria sepsis, zvirwere zvinokonzera mafungiro (semuenzaniso, histoplasmosis), uye zvirwere zvinokonzerwa nemakiriniki epamuviri. Nyevero inopawo zano rekuregererwa kweAmjevita kana chirwere chakakomba kana chirwere chinowedzera panguva yekurapa. Chiyero cheBAT latent rinokurudzirwa kusati yatanga kurapwa naAmjevita. Uyewo, avo vanorapwa neAmjevita vanofanira kuongororwa neTB inoshanda, kunyange kana chirwere chavo chekare chepabonde chisina kunaka.
Nezvekunyevera kwekuvhiringidza, kwakave nemishumo ye lymphoma nedzimwe mhirizhonga (dzimwe dzaive dzakauraya) muvana nevechiri kuyaruka vakatarisirwa neTNF blockers. Uyezve, pane mararamiro emakambani ekutengeserana kwechirwere chisingawanzoiti cheT-cell lymphoma, chinonzi HSTCL (hepatosplenic T-cell lymphoma), muvechiri kuyaruka uye vechidiki vane zvirwere zvinoputika zvinorapwa ne TNF blockers.
Dzimwe nyevero dzakapiwa mukugadzirisa mashoko:
- Iwe haufaniri kutanga Amjevita panguva yehutachiona hwehutachiona.
- Amjevita inofanira kumira kana utachiona hukaoma.
- Anti-fungal therapy inofanira kufungidzirwa kune vanhu vanovandudza chirwere chetachiona apo vanorapwa neAmjevita uye vanogara kana kuenda kumatunhu uko zvirwere zvefungal zviripo.
- Allergic reactions kana anaphylaxis inogona kuitika neAmjevita.
- Hepatitis B reactivation inogona kuitika apo inorapwa neAmjevita. Vatakuri veHBV vanofanira kuongororwa.
- Kutanga mutsva kana kuwedzera kwechirwere chekudzivirira chinogona kuitika neAmjevita.
- Ropa risina kugadzikana rinogona kuitika, kusanganisira cytopenias (yakadzika nhamba yemasero eropa) uye pancytopenia (pasi shoma remasero matsvuku eropa, masero eropa, uye maplatelet).
- Kutanga kutsva kana kuora mwoyo kusakundikana kunogona kuitika pavanorapwa neAmjevita.
- Lupus-like syndrome inogona kukura apo inorapwa neAmjevita, inoda kuregera.
Kubatana Kwemishonga
Kune ngozi yakawedzerwa yehutachiona hwehutachiona pamwe nekubatanidzwa kweNADF blockers uye Kineret (anakinra) kana Orencia (abatacept) . Saka, Amjevita haifaniri kushandiswa newakinra kana abatacept. Uyewo, kurarama zvirwere kunofanira kudziviswa nekushandisa Amjevita.
The Bottom Line
Bhiosimilar inogamuchirwa kuburikidza nouchapupu hunotsigira kuti mishonga "yakanyatsofanana" kune imwe yakagamuchirwa mishonga ye biologic, iyo inonzi inonzi chiremba zvinodhaka. Kubvumirana kunotaura kuti hapana mishonga inogadzirisa zvinokonzerwa pakati pe biosimilar uye inotaura nezvemishonga.
Izvozvo zvakati, pakave nekuvhiringidzika uye mhirizhonga yemibvunzo yakakomberedza mhedziso yezvinyorwa zvehupenyu, kunyange isati yatanga kubvumidzwa. Zvinogona here kuva zana zana muhutano hwekuti biosimilar uye iyo inotaura zvinodhaka zvakafanana? Nekunyora zvinangwa, bhaosimilar inogona kushandurana neyo inotaura zvinodhaka here? Ko makambani einishuwarenzi achamanikidza kushandiswa kwezvinhu zvinokonzerwa nehuwandu hwezvinhu nekuda kwekuderedza mari?
Iyi mibvunzo mikuru uye inoramba iine mibvunzo. Kunyange zvazvo biosimilar inogona kunyatsorongerwa kune munhu achangobva kuongororwa, zvakachenjera here kutarisira murwere ari kuita zvakanaka pane biologic kuti achinje kune biosimilar?
Pakupera kwa2016, pakanga pane kuiswa kwakanyatsonaka kweApplectra. Erelzi haizotungamiri pamberi pe 2018 sezvo yakasungwa mumatare epamutemo naAmgen. Kuchinja kwechokwadi kwezvinyorwa zvehupenyu uye mazita avo zvinodhaka hazvisati zvasimbiswa nenzira inobvisa varwere uye vanachiremba vachifunga zvizere. Zvichida munguva, izvi zvichachinja. Panguva ino, kurukura nechiremba wako kuti uone kuti ndeipi nzira yakakunakira iwe.
> Sources:
> Amjevita. Kunyora Mashoko. Amgen. Revised 9/2016.
> Palmer, Eric. > Sandoz musoro: Enbrel biosimilar Erelzi haazoenderi mberi kwe 2018, kunonoka nekutongwa kwematare . > FiercePharma. January 25, 2017.
> Shaw, Gina. Biosimilar Infliximab Inotarisira Matanho Mumusika. Specialty Pharmacy Continuum. January 23, 2017.