I-Amjevita (adalimumab-atto), i- biosimilar ku- Humira (adalimumab) , ivunyiwe yi-FDA ye- arthritis ye- rheumatoid nezifo ezihlukahlukene zokuvuvukala. U-Amjevita waba yi-biosimilar yesine ezovunyelwa yi-FDA. Ama-biosimilars, kanye nosuku lwabo lokugunyazwa kwe-FDA, yilo:
- I-Zarxio (filgrastim-sndz) - Mashi 6, 2015
- I-Inflectra (i-infliximab-dyyb) - ngo-Ephreli 5, 2016
- Erelzi (etanercept-szzs) - Agasti 30, 2016
- Amjevita (adalimumab-atto) - September 23, 2016
I-Zarxio, ngokungafani nezinye, ayiboniswa ngezifo ze- rheumatic , kodwa kunalokho kuyisici sokukhula kwe-leukocyte. I-Inflectra yi-biosimilar ku- Remicade (i-infliximab) . U-Erelzi yi-biosimilar ku- Enbrel (etanercept) . I-Enbrel, Remicade, ne-Humira yizidakamizwa ze-biologic , ezihlukaniswa njengezivimbela ze- TNF .
Izinkomba ze-Amjevita
I-Amjevita iboniswa ekwelapheni:
- I-Arthritis Ye-Rheumatoid - Ukunciphisa izimpawu nezimpawu, kuvimbela ukuqhuma kokulimala kwesakhiwo, futhi kuthuthukise umsebenzi womzimba kubantu abadala ngokulinganisela ukuya ku-arthritis esebenzayo yesifo sofuba.
- I-Juvenile Idiopathic Arthritis (JIA) - Ukunciphisa izimpawu nezimpawu ngokulinganisela kuya kwe-JIA ephikisanayo ye-Polyarticular ezinganeni ezine-4 noma ngaphezulu.
- I-Arthritis Psoriatic - Ukunciphisa izimpawu nezimpawu, kuvimbela ukuqhubeka kokulimala kwesakhiwo, futhi kuthuthukise umsebenzi womzimba kubantu abadala abane-arthritis esebenzayo ye-psoriatic.
- I-Ankylosing Spondylitis - Ukunciphisa izimpawu nezimpawu kubantu abadala abane-spondylitis e-ankylosing esebenzayo.
- Izifo Zama-Adult Crohn - Ukunciphisa izimpawu nezimpawu; ukugqugquzela nokugcina ukuxolelwa komtholampilo kubantu abadala ngokulinganisela kwesifo esibucayi se-Crohn esasiphendule ngokwanele ukwelashwa okuvamile, noma sehlekelwe impendulo yabo ku-Remicade, noma nje ayikwazanga ukubekezelela i-Remicade.
- I-Ulcerative Colitis - Ukukhuthaza nokugcina ukuxolelwa komtholampilo kubantu abadala abanomdlavuza we-ulcerative obunembile noma okhuthele kakhulu obenempendulo engenele kuma-immunosuppressants.
- I-Plaque Psoriasis - Kubantu abadala abadala abanomqondo ohambelana ne-plaque psoriasis ongapheliyo abafanelekile ukwelashwa kohlelo noma i-phototherapy; futhi, uma ezinye izindlela zokwelapha ezihlelekile zibhekwa njengezifanelekile.
Isilinganiso Esinconywayo Nokuphatha
I-Amjevita ilawulwa yi-injection encane. Itholakala njengomthamo we-mL 40 mg / 0.8 we-mL ku-auto -jectject esebenzayo eyodwa-esebenzayo, njenge-dose 40 mg / 0.8 mL insiza eyodwa yokusetshenziswa yesilayidi ekhethiwe, ne-20 mg / 0.4 mL eklasini eyodwa ekhethiwe isirinji.
Umthamo ophakanyisiwe we-Amjevita we-arthritis ye-rheumatoid, i-psoriatic arthritis, ne-ankylosing spondylitis ingama-40 mg njalo ngesonto. Uma une-arthritis ye-rheumatoid futhi ungathathi i- methotrexate , umthamo ovame kakhulu we-40 mg isonto ngalinye ungacatshangwa.
Kuzingane ezilinganisa phakathi kwamakhilogremu angu-33 namaphilisi angama-65, umthamo ophakanyisiwe we-Amjevita ungama-20 mg. njalo njalo ngesonto. Umthamo wezingane olinganisa amakhilogremu angu-66 noma ngaphezulu ngu 40 mg. njalo njalo ngesonto.
Nge-Crohn's and ulcerative colitis, ngosuku lwe-1 lwezokwelapha nge-Amjevita, umthamo ungama-160 mg.
(inothi: ingahlukaniswa ngo-80 mg ngaphezu kwezinsuku ezimbili ezilandelanayo; ngosuku lwe-15, umthamo u-80 mg; futhi ngosuku lwe-29, uqala umthamo wesondlo ka-40 mg njalo ngesonto. , umthamo wokuqala ungama-80 mg bese kuthi ngesonto elandela umthamo wokuqala, umthamo wesondlo ungama-40 mg.
Imiphumela emibi, ukusabela okubi, nokungafani
Ukusabela okuvamile okubi okuhlobene no-Amjevita kuhlanganisa izifo (njenge-sinusitis noma izifo ezingaphezulu zokuphefumula), ukuphendula kwesayithi, ukukhanda ikhanda nokukhwabanisa. Awekho ukuphikisana okufakwe ohlwini lokuchazwa kwe-Amjevita.
Ukuxwayiswa nokuqapha
I-Amjevita iza ne-Black Box Warning, isixwayiso esibi kakhulu esakhishwa yi-FDA.
Isixwayiso sebhokisi elimnyama kungenxa yezifo ezimbi kanye nokulimala. Ngokuqondile, i-Amjevita ihlobene nengozi eyengeziwe yokwelashwa okungathí sina okungaholela esibhedlela noma ekufeni, kuhlanganise ne-TB (isifo sofuba), isifo se-bacterial sepsis, izifo ezithathelwanayo ze-fungal (isib. I-histoplasmosis), kanye nokutheleleka okubangelwa ama-bacterial opportunistic. Isixwayiso siphinde sicele ukuyeka ukusebenza kwe-Amjevita uma ukutheleleka okujulile noma i-sepsis iqala ngesikhathi sokwelashwa. Ukuhlolwa kwe-TB evulekile kunconywa ngaphambi kokuqala ukwelashwa ne-Amjevita. Futhi, labo abaphathwa nge-Amjevita kumele bahlolwe nge-TB esebenzayo, noma ngabe ukuhlolwa kwabo kwe-TB okulindelekile akubi.
Ngokuphathelene nesilumkiso esibulalayo, kuye kwaba nemibiko ye- lymphoma nezinye izidakamizwa (ezinye zazo ezabulawa) ezinganeni nasebancane eziphathwa nge-block block TNF. Futhi, kube khona imibiko yokuthunyelwa kwe-post-marketing ye-T-cell lymphoma engavamile, ebizwa nge-HSTCL (i-hepatosplenic T-cell lymphoma), entsheni kanye nabantu abadala abasha abanezifo ezifuywayo ezikhukhumeza eziphathwa nge-TNF blockers.
Izixwayiso eziningi zanikezwa ngolwazi lokubeka:
- Akufanele uqale i-Amjevita ngesikhathi sokutheleleka okusebenzayo.
- Amjevita kumele imiswe uma ukutheleleka kuba sína.
- I-anti-fungal therapy kufanele ibhekwe ngabantu abahlakulela ukugula kwesistimu ngenkathi bephathwa nge-Amjevita futhi bahlala noma bahambele ezifundeni lapho ukutheleleka kwe-fungal kubonakala khona.
- Ukusabela kwe-allergenic noma i-anaphylaxis kungenzeka nge-Amjevita.
- Ukuvuselelwa kwe-Hepatitis B kungenzeka uma kuphathwa nge-Amjevita. Abathwali be-HBV kufanele baqashwe.
- Ukuqala okusha noma ukuwohloka kwesifo sokudoba kungase kwenzeke nge-Amjevita.
- Ukungahleleki kwegazi kungase kwenzeke, kufaka phakathi i-cytopenias (inombolo ephansi yamangqamuzana egazi) ne-pancytopenia (inombolo ephansi yamangqamuzana egazi abomvu, amaseli egazi amhlophe, namaplatelet).
- Ukwehluleka kwenhliziyo noma ukuhlukumeza kwenhliziyo okuqhubekayo kungase kwenzeke ngenkathi kuphathwa nge-Amjevita.
- I-Lupus-like syndrome ingase ithuthuke ngenkathi iphathwa nge-Amjevita, idinga ukuyeka.
Ukusebenzisana kwezidakamizwa
Kukhona ingozi eyengeziwe yokwelashwa okukhulu kakhulu ngokuhlanganiswa kwama-block block TNF no-Kineret (anakinra) noma i- Orencia (abatacept) . Ngakho-ke, i-Amjevita akufanele isetshenziswe ne-anakinra noma i-abatacept. Futhi, imishanguzo ephilayo kufanele igwenywe ngokusetshenziswa kwe-Amjevita.
Okubalulekile
I-biosimilar ithola imvume ngokusekelwe ebufakazini obusekela ukuthi lesi sidakamizwa "sifana kakhulu" nesidakamizwa se-biologic esivunyiwe ngaphambili, esibizwa ngokuthi yisisetshenziswa semithi. Ukwamukelwa kuveza ukuthi ayikho umehluko wempilo phakathi kwe-biosimilar kanye nomuthi wayo wokubhekisela.
Lokho kusho, sekube khona ukudideka kanye nemibuzo yezinkinga ezizungeze umqondo wezinhlobo zezinto eziphilayo, ngisho nangaphambi kokuba kuqala kuqala. Kungaba khona ukuqinisekiswa kwamaphesenti angu-100 ukuthi i-biosimilar kanye nomuthi wayo wokubhekisela uyalingana? Ukuze uhlele izinhloso, ingabe i-biosimilar ingashintshaniswa nomuthi wayo wokubhekisela? Ingabe izinkampani zomshuwalense zizophoqelela ukusebenzisa ama-biosimilars ngenxa yokunciphisa izindleko?
Lezi imibuzo ezinkulu kakhulu futhi zihlala njengemibuzo. Ngenkathi i-biosimilar ingahle ibekwe ngokucacile ngesiguli esanda kutholakala, ingabe kuwukuhlakanipha ukulindela isiguli esenza kahle kwi-biologic ukushintshela kwi-biosimilar yayo?
Ekupheleni kuka-2016, kwakukhona ukuqaliswa okuncane kwe-Inflectra. I-Erelzi ngeke iqalise ngaphambi kuka-2018 njengoba ihlanganiswe empi yezomthetho no-Amgen. Ukushintshaniswa kweqiniso kwama-biosimilars kanye nezidakamizwa zabo zokubhekisela akukaze kwenziwe ngendlela eshiya iziguli nodokotela bazizwe beqiniseka ngokugcwele. Mhlawumbe ngokuhamba kwesikhathi, lokhu kuzoshintsha. Okwamanje, xoxa nodokotela wakho ukuze ubone ukuthi iyiphi inketho engcono kuwe.
> Imithombo:
> Amjevita. Ukubeka imininingwane. Amgen. Kubuyekezwe i-9/2016.
> Palmer, u-Eric. > Inhloko ye-Sandoz: I-Enbrel biosimilar Erelzi ngeke iqalise ngaphambi kuka-2018, ibambezelwe yimpi yomthetho . > FiercePharma. NgoJanuwari 25, 2017.
> Shaw, Gina. I-Biosimilar Infliximab Iqaphela Izinyathelo Eziqaphile Emakethe. I-Specialty Pharmacy Continuum. NgoJanuwari 23, 2017.