I-Amjevita (adalimumab-atto), i- biosimilar ku- Humira (adalimumab) , ivunyiwe yi-FDA kwi- arthritis ye- rheumatoid kunye nezifo ezahlukahlukeneyo ezivuthayo. I-Amjevita yaba yi-biosimilar yesine eya kuvunywa yi-FDA. I-biosimilars, kunye nomhla wabo wokuvunywa kwe-FDA, ngaba:
- Zarxio (filgrastim-sndz) - ngoMatshi 6, 2015
- I-Inflectra (infliximab-dyyb) -Aprili 5, 2016
- Erelzi (etanercept-szzs) - Agasti 30, 2016
- Amjevita (adalimumab-atto) - Septemba 23, 2016
UZarxio, ngokungafani nabanye, akabonakalwanga kwizifo ze- rheumatic , kodwa kunoko kukukhula kwe-leukocyte. I-Inflectra yi-biosimilar kwi- Remicade (i-infliximab) . U-Erelzi yi-biosimilar kwi- Enbrel (etanercept) . I-Enbrel, Remicade, kunye ne-Humira ziiyobisi ze- biologic , zichazwe njenge- block block ye-TNF .
Imiqondiso ye-Amjevita
I-Amjevita iboniswe ukunyanga:
- I-Rheumatoid Arthritis - Ukunciphisa iimpawu kunye neempawu, ukuvimbela ukuqhubela phambili komonakalo wesiqhelo, nokuphucula umsebenzi womzimba kubantu abadala ngokuthe ngqo kwi-arthritis esebenzayo.
- IJunile Idiopathic Arthritis (JIA) - Ukunciphisa imiqondiso kunye neempawu zentsholongwane kwi-Jyarraphyular JIA kubantwana abane-4 ubudala okanye ngaphezulu.
- I-Psoriatic Arthritis - Ukunciphisa impawu kunye neempawu, ukuvimbela ukuqhubela phambili komonakalo wesakhiwo, nokuphucula umsebenzi womzimba kubantu abadala abane-arthritis esebenzayo ye-psoriatic.
- I-Ankylosing Spondylitis - Ukunciphisa impawu kunye neempawu kubantu abadala abane-spondylitis engasebenzi.
- Izifo ze-Crohn's Adult - Ukunciphisa iimpawu kunye neempawu; ukunyusa nokugcina ukuxolelwa klinikhi kubantu abadala ngokuthe ngqo kwi-Crohn's disease esebenzayo eyayinempendulo enganeleyo kwonyango oluqhelekileyo, okanye ilahlekelwe impendulo yabo kwiRicicade, okanye ayizange ikwazi ukunyamezela iMicicade.
- Ulcerative Colitis - Ukunyusa nokugcina ukuxolelwa klinikhi kubantu abadala abanomdla wokuqhathaniswa nesilonda esiswini okanye esichukumisayo esineempendulo ezinganeleyo kuma-immunosuppressants.
- I-Plaque Psoriasis - Kwabadala abanomlinganiselo othe ngqo kwi-plaque psoriasis engapheliyo abafanelekileyo abachaphazelekayo kwindlela yokwelapha inkqubo okanye i-phototherapy; Kwakhona, xa ezinye iindlela zonyango zithathwa njengento engafanelekanga.
Ukuphakanyiswa kweeNkqubo kunye noLawulo
I-Amjevita ilawulwa ngumjovo ongaphantsi. Itholakala njenge-dose 40 mg / 0.8 mL umthamo kwisitya esisodwa esisetyenzisiweyo seCheckClick autoinjector, njenge-40 mg / 0.8 mL isitifiketi kwisirinji yeglasi ekhethiweyo esisodwa kunye ne-20 mg / 0.4 mL kwisixhobo esisodwa esisetyenziswayo isirinji.
I-dose ephakanyisiweyo ye-Amjevita ye-rheumatoid arthritis, i-psoriatic arthritis, kunye ne-spondylitis engena-ankylosing i-40 mg nganye ngeveki. Ukuba une-arthritis ye-rheumatoid kwaye ungathathi i- methotrexate , i-dose ephindwe rhoqo ye-40 mg nganye ngeveki inokuqwalaselwa.
Kubantwana abalinganisa phakathi kwama-33 iipounds kunye nama-pounds angama-65, i-dose ephakanyisiweyo ye-Amjevita ingama-20 mg. nganye ngeveki. I-dose yabantwana abalinganisela iipounds ezingama-66 okanye ngaphezulu 40 mg. nganye ngeveki.
Ngenxa yesifo sikaCrohn kunye ne-ulcerative colitis, ngomhla we-1 wonyango kunye ne-Amjevita, umthamo ungama-160 mg.
(qaphela: ingahle ihlukaniswe ngo-80 mg ngaphezulu kweentsuku ezimbini ezilandelelanayo; ngomhla we-15, umthamo ungama-80 mg; kwaye ngomhla we-29, uqala umthamo wesondlo wama-40 mg nganye ngeveki.Abantu abane-psoriasis ye-plaque , umthamo wokuqala u-80 mg kwaye emva kweveki elandelayo kwimizi yokuqala, umthamo wesondlo unama-40 mg.
Iimpawu eziPhakathi, iimpendulo ezingalunganga kunye nokuchasene
Izimpembelelo eziqhelekileyo ezichaphazelekayo ezinxulumene ne-Amjevita ziquka izifo (ezifana nesinitis okanye izifo eziphezulu zokuphefumula), ukuphendulwa kwendawo ye-injection, intloko yesifo kunye nokukhwabanisa. Akukho zichaso ezichazwe kwicandelo lokwazisa i-Amjevita.
Izilumkiso kunye nokuqapha
I-Amjevita iza neSilumkiso seBlack Black, isilumkiso esisisona sikhulu esakhutshwa yi-FDA.
Isilumkiso sebhokisi emnyama kukulungiselela izifo ezinzulu kunye nokugula. Ngokukodwa, i-Amjevita idibene nomngcipheko ophezulu wokusuleleka osuleleka esibhedlele okanye ekufeni, kuquka ne-TB (isifo sofuba), isifo se-bacterial sepsis, izifo ezibangelwa yi-fungal (eg, i-histoplasmosis), kunye nezifo ezibangelwa zizifo ezifo. Isilumkiso sinika icebo lokuyeka ukukhutshwa kwe-Amjevita ukuba ukusuleleka kwintsholongwane okanye i-sepsis ikhula ngexesha lotyando. Uvavanyo lwe-TB elambileyo lunconywe ngaphambi kokuqala unyango kunye ne-Amjevita. Kwakhona, abo baphathwa nge-Amjevita kufuneka bahlolwe kwi-TB esebenzayo, nokuba ngaba uvavanyo lwabo lwe-TB olulandelayo alubi.
Ngokubhekiselele kwisilumkiso esiyingozi, kukho iingxelo ze- lymphoma kunye nezinye izigulane (ezinye zazo zabulawa) kubantwana nakwishumi elivisayo baphathwa nge-block blockers. Kwakhona, kukho iingxelo zentengiso zentlobo engaqhelekanga ye-T-cell lymphoma, ekubhekiselwe kuyo njengeHSTCL (i-hepatosplenic T-cell lymphoma), kwiintsholongwane kunye nabantu abadala abasenokuba nezifo ezikhukhulayo ezikhuphayo eziphathwe nge-TNF blockers.
Izilumkiso ezingaphezulu zanikezwa ngolwazi lokumisela:
- Akufanele uqale i-Amjevita ngexesha lokusuleleka.
- I-Amjevita kufuneka imiswe ukuba usulelo luba lukhulu.
- Kufuneka kuqwalaselwe unyango olukhuselekileyo kubantu abakha ukugula kwenkqubo xa bephathwa nge-Amjevita baze baphile okanye bahambe baye kwiindawo apho izifo ezifayilini zihlala khona.
- Ukuphendulwa kwe-allergen okanye i-anaphylaxis inokwenzeka nge-Amjevita.
- Ukuvuselelwa kwe-Hepatitis B kuya kwenzeka xa kuphathwa nge-Amjevita. Iithwali ze-HBV mazibekwe iliso.
- Ukuqala okutsha okanye ukugqithisa kwesifo sokudemokhrasi kungahle kwenzeke kunye ne-Amjevita.
- Ukungaqhelekanga kwegazi kungahle kwenzeke, kuquka i-cytopenias (inombolo ephantsi yeeseli zegazi) ne-pancytopenia (inani eliphantsi leeseli ezibomvu zegazi, iiseli zegazi ezimhlophe kunye neeplatelets).
- Ukuqala okutsha okanye ukungaphumeleli kwenhliziyo kungenzeka xa uphathwa nge-Amjevita.
- I-Lupus-like syndrome inokuphuhliswa xa iphathwa nge-Amjevita, idinga ukuyeka.
Ukusebenzisana kweziyobisi
Kukho ubungozi obunzulu bokungenwa kwezifo ezinzulu kunye ne-TNF blockers kunye neKineret (anakinra) okanye iOrencia (abatacept) . Ngoko ke, i-Amjevita ayifanele isetyenziswe kunye ne-anakinra okanye i-abatacept. Kwakhona, baphile izitofu kufuneka bagwenywe nge-Amjevita.
Ngaphantsi
I-biosimilar ifumana imvume ngokusekelwe kububungqina obuxhasa ukuba isilwanyana "siyafana kakhulu" kwisicatshulwa se-biologic esivunyiweyo ngaphambili, esibizwa ngokuba yiziyobisi. Ukuvunyelwa kukubonisa ukuba akukho ntlukwano enokliniki phakathi kwe-biosimilar kunye neziyobisi zalo.
Oko kwathiwa, kukho ukudideka kunye ne-swirl yemibuzo ejikeleze ingcamango ye-biosimilars, nangaphambi kokuqala kokuvunywa. Ingaba kukho ukuqinisekiswa kweepesenti ezingama-100 ukuba i-biosimilar kunye nesichengiso sayo seziyobisi zilingana? Ukulungiselela iinjongo, ngaba i-biosimilar ishintshana kunye nesichengiso sayo seziyobisi? Ngaba iinkampani ze-inshorensi ziya kunyanzelisa ukusebenzisa i-biosimilars ngenxa yokunciphisa iindleko?
Le mibuzo ikhulu kakhulu kwaye ihlala ingumbuzo. Nangona i-biosimilar ingayinqunyelwa ngokucacileyo isigulane esandulandulileyo, ngaba kulungile ukulindela isigulane esenza kakuhle kwi-biologic ukutshintsha kwi-biosimilar yayo?
Ekupheleni konyaka we-2016, kwakukho ukuqaliswa okuthe tye kwe-Inflectra. U-Erelzi akayi kuqalisa phambi ko-2018 njengoko ihlanganiswe kwimfazwe esemthethweni kunye no-Amgen. Ukutshintshaniswa kwenene kwee-biosimilars kunye nokusetyenziswa kwazo izidakamizwa akukafuneka kusekwe ngendlela eyayeka izigulane kunye noogqirha bazive beqinisekile. Mhlawumbi ngexesha, oku kuya kutshintsha. Okwangoku, xubusha nogqirha wakho ukuba ubone ukuba yiyiphi enye into efanelekileyo kuwe.
> Imithombo:
> Amjevita. Ulwaziso loLwazi. Amgen. I-Revised 9/2016.
> Palmer, uEric. > Inhloko ye-Sandoz: I-Enbrel biosimilar Erelzi ayiyi kuqaliswa ngaphambi ko-2018, ilibazisekile yimfazwe esemthethweni . > FiercePharma. NgoJanuwari 25, 2017.
> Shaw, Gina. I-Biosimilar Infliximab IQaphela iiNyathelo eziMakethe. Specialty Pharmacy Continuum. NgoJanuwari 23, 2017.