Yakagamuchirwa Kwemamwe Marudzi Anokonzera Arthritis, Nokudaro
Erelzi (etanercept-szzs), biosimilar kuna Enbrel (etanercept) , yakagamuchirwa neDFA musi waAugust 30, 2016 kuti iite zviratidzo zvakafanana izvo Enbrel aivimbwa pakutanga. Enbrel ndiyo yaiva yekutanga biologic drug yakagamuchirwa nehutukuroid arthritis uye zvimwe zvimwe zvinokonzera kurwara kweArthritis muna 1998.
Bhiosimilar chigadzirwa chezvinyorwa chinonyanya kufanana nechigadzirwa chekare cheBAA-chinogamuchirwa (inozivikanwa semutauro), uye hachiratidzi maitiro akasiyana-siyana emagetsi kubva pane zvinyorwa zvine chokuita nekuchengeteka uye kubudirira.
Ikoko kunogona kunge kuine kusiyana kwakasiyana mumakiriniki asingashandi. Zvisungo zvisina basa zveErelzi zvinosanganisira sodium citrate, sucrose, sodium chloride, lysine, uye citric acid.
Erelzi inoumbwa naSandoz, kambani iyo yakanga ine biosimilar yokutanga inogamuchirwa neRDA, (Zarxio [filgrastim-sndz] - biosimilar ku white white booster Neupogen (filgrastim). Bhiosimilar yekutanga yezvokuvhiringidza maitiro eArthritis yaiva Inflectra (infliximab-dyyb) iyo inonzi biosimilar kuna Remicade (infliximab) . Kugamuchirwa kwaErelzi kwakauya pazvitsva zvekusimbiswa kwema 20-0 pamwe chete neDAA Arthritis Advisory Committee kugamuchira mushonga wezviratidzo zvose zvehuwandu hwezvinodhaka.
Zviratidzo
Erelzi inonzi tumor necrosis factor (TNF) blocker inoratidzirwa:
- rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis
- plaque psoriasis
- juvenile idiopathic arthritis , polyarticular, muvana 2 makore kana kupfuura
Dosage uye Administration
Erelzi inotungamirirwa nejasi rejinga. Inowanikwa se 25 mg / 0.5mL uye 50 mg / mL sarudzo mune imwe nhengo yakagadzirirwa siriti. Erelzi inouyawo mune 50mg / mL solution mune imwe yakagadzirwa Sensoready pen.
Nhamba yakakurudzirwa yevanhu vane vanhu vakuru vane rheumatoid arthritis kana psoriatic arthritis ndeye 50 mg kamwe chete kwevhiki, pamwe kana pasina methotrexate .
Nhamba yakakurudzirwa yevanhu vane ankylosing spondylitis 50 mg kamwe kamwe. Pamusoro pevanhu vakuru vechipori psoriasis, chirongwa chinorayirwa cheErelzi chinokwana 50 mg kaviri vhiki imwe neimwe kwemwedzi mitatu zvichizotevera 50 mg kwevhiki. Chirwere chevana vaduku chinonzi idiopathic arthritis chinovakirwa pauremu-kune vana vanorema kudarika 63 kg, chiyero chacho chinokwana 0.8mg / kg kwevhiki nevhiki neine muwandu we50 mg pr vhiki.
Migumisiro Yechiri
Sezvakaita chero mishonga ipi, kune migumisiro yakaipa uye zviitiko zvakashata zvinosangana naErelzi. Zviitiko zvinowanzovhiringidza zvinosangana ne etanercept zvipembenene uye nekujekesa nzvimbo yekuita . Kubva pane zvidzidzo zvekuchipatara uye chiitiko chekusimudzira zviitiko, zviitiko zvakakomba zvakakomba zvinosangana ne etanercept zvinosanganisira zvirwere, neurologic zvinetso, congestive moyo kusakatika, uye hematologic zviitiko (kureva, kushaya ropa).
Contraindications
Erelzi haafaniri kupa kune munhu ane sepsis .
Manyevero
Pane zviyeuchidzo zvinokosha uye zvidziviriro zvinoshandiswa nekushandiswa kweErelzi izvo zvisingafaniri kuregererwa:
- Erelzi haafaniri kutanga panguva yehutachiona hwehutachiona. Kana hutachiona hwehutachiona hunotanga panguva yekurapa, Erelzi inogona kumira.
- Mune vanhu vanoenda kune kana vanogara kune dzimwe nzvimbo dzinosangana nemasikirwo, kana chirwere chakakomba chirwere chichikura apo ichibata neErelzi, anti-fungal therapy inofanira kuonekwa.
- Kuedza kuderedza zvirwere kunogona kukura apo uchibata neErelzi.
- Lymphoma matambudziko akaitika kune vanhu vanobatwa neNADF blockers.
- Kukanganisa kwemwoyo kunokanganisa kunogona kuitika, zvingava zvitsva kana kuti kuipa.
- Vanhu vane zviratidzo zvepancytopenia kana aplastic anemia vanofanira kutsvaga kurapwa uye vanofunga kumira Erelzi.
- Vanhu vane nhoroondo yeHepatitis B vanofanira kuongororwa kuti vashandise zvakare apo vachibatwa neErelzi uye mwedzi yakaverengeka pashure.
- Anaphylaxis kana zvakakomba zvinokonzerwa nehutachiona zvinogona kuitika pazvinobatwa neErelzi.
- Lupus-like syndrome kana autoimmune hepatitis inogona kukura. Kana zvimwe zvichiitika, Erelzi inofanira kumira.
Kubatana Kwemishonga
Pakave pasina kuongororwa kwakaitwa pamusoro pekubatana kwemishonga pamwe ne etanercept. Kubva kune zvimwe zvidzidzo zvakagadzirirwa kuti vanhu vanorapwa ne etanercept vanofanira KURA:
- rarama zvirwere
- kushandiswa panguva imwe chete kweimwe biologic zvinodhaka
- kushandiswa panguva imwechete yeCytoxan (cyclophosphamide)
- kushandiswa panguva imwechete yeAzulfidine (sulfasalazine)
The Bottom Line
Icho chinangwa chinangwa chekusimudzira biosimilars ndechokupa varwere uye vanachiremba mamwe maitiro ekurapa pamutengo unodhura, zvakanyanya kuderera kupfuura mari yekureva zvinodhaka. Nezvo izvo zvingaita zvakanaka pakutanga kuverenga, pane zvinonetsa zvakajeka izvo zvasvika. Iko kunetseka kwakanyanya kuchiri kungove kana mabhiosimilar "akaenzana" kune avo vanotaura zvinodhaka. Biosimilars ave achinzi "yakafanana" asi iyo yakafanana yakaenzana here? Mubvunzo iwoyo wakanga wapindurwa zvinogutsa here? Iko kutamba kunotenderera izwi rinowanzosiya vakawanda vachiri kunzwa vasinganzwisisiki.
Kubva muna 2016, nhamba yemutengo haina kuziviswa zvimwe. Saka, tinofanira kumirira kuti tinyatsoona kuti "zvakanyanya kutengesa" zvinoshandura sei kuva madhora chaiwo. Iwe unogona kufunga kuti uone kuti Inflectra, Remicade biosimilar yakagamuchirwa munaApril 2016, yakaita maererano nekutengesa uye kubudirira. Kubva muna 2016, haina kutanga muUnited States.
Kuwedzera kune kuvhiringidzika, pane dare remhosva pamusoro pemibvunzo yepentent. Kunyange zvazvo biosimilars inogona kuva yechokwadi chaiyo mune ramangwana, nokuti ikozvino inoratidzika yakazara nezvinetso. Taura nechiremba wako pamusoro pekuti kana kwete here sarudzo yakanaka kwauri.
> Kwakabva:
> Erelzi. Kunyatsorondedzera Mazano uye Mazano Okurapa . Sandoz, Inc. Revised 08/2016.