Futhi ivunyelwe i-Psoriatic Arthritis, i-Ankylosing Spondylitis, nokuningi
Sibutsetelo
I-Inflectra (i-infliximab-dyyb), i-biosimilar ku- Remicade (infliximab), yamukelwa yi-US Food and Drug Administration (FDA) ngo-Ephreli 5, 2016. Ngokusho kwe-FDA, "Umkhiqizo we-biosimilar ngumkhiqizo wezinto eziphilayo ovunyelwe ngokusekelwe ekuboniseni ukuthi ifana kakhulu nomkhiqizo we-bio ovunyelwe yi-FDA, owaziwa njengomkhiqizo wokubhekisela, futhi awunawo umehluko wempilo ngokuphepha nokusebenza kusukela kumkhiqizo wokubhekisela.
Izingxabano ezincane kuphela ezingxenyeni ezingasebenzi ezingavumelekile emitholampilo zivumelekile kumikhiqizo ye-biosimilar. "Khumbula, i- blocker ye-TNF eyenziwe yi-Janssen Biotech, Inc., yisidakamizwa sokubhekisela ku-Inflectra.
I-Inflectra ikhiqizwa yi-Celltrion, Inc (esekelwe e-Yeonsu-gu, i-Incheon, i-Republic of Korea) i-Hospira yaseLake Forest, e-Illinois. I-Inflectra yi-biosimilar yesibili evunyelwe e-United States yi-FDA. Owokuqala, uZarxio, wamukelwa ngoMashi 6, 2015 ngezinkomba ezithile ezihlobene nomdlavuza.
Izinkomba
I-Inflectra ivunyelwe futhi ingahle ibekwe:
- iziguli ezinomthelela emathunjini e- rheumatoid arthritis .
- iziguli ezine- spondylitis e-ankylosing esebenzayo.
- iziguli ezine- arthritis esebenzayo ye- psoriatic .
- iziguli ezikhulile ezine-psoriasis ezinamandla ezingapheli.
- iziguli ezikhulile noma izingane ezineminyaka engu-6 ubudala nangaphezulu ngokulingana nesifo sikaCrohn esiwukhuthele kakhulu esasiphendule ngokwanele ukwelashwa okuvamile.
- abadala ngokulinganisela ukuya ekilitini ye-ulcerative colitis ekhuthele kakhulu eyayiphendule ngokwanele ukwelashwa okuvamile.
Ngenxa ye-arthritis ye-rheumatoid, i-Inflectra isetshenziselwa ukunciphisa izimpawu nezimpawu ezihambisana nesifo, zivimbela ukuqhubeka komonakalo ohlangene, nokuthuthukisa umsebenzi womzimba. Kuziguli ezine-spondylitis e-ankylosing, i-Inflectra iboniswa ukunciphisa izimpawu nezimpawu.
Nge-arthritis ye-psoriatic, i-Inflectra ingase ibekwe ukuba kuncishiswe izimpawu kanye nezimpawu zesifo samathambo, kuvimbela ukuqhubeka kokulimala kwesakhiwo nokuthuthukisa ukusebenza komzimba.
Isilinganiso Nokuphatha
Ngokwe-arthritis ye-rheumatoid, i-Inflectra iphathwa njenge-infusion emangcwabeni (enikezwe isikhathi esingenani amahora angu-2) ngesilinganiso sika-3mg / kg enikezwe kuma-0, 2, nama-6 amasonto. Emva kwalokho, umthamo wesondlo ka 3 mg / kg ulawulwa njalo emva kwamasonto ayisithupha. Iziguli eziphathwa nge-Inflectra ye-arthritis ye-rheumatoid kufanele nazo zithathe methotrexate . Iziguli ezinempendulo enganele ngokwezilinganiso ezibalwe ngenhla zingase zibe nomthamo ongu-10mg / kg noma i-interval phakathi kwamanani angancishiswa kuwo onke amasonto amane. Ukulungiswa kungase kwande ingozi yokuphendula okubi.
Nge-spondylitis engavumelaniyo, umthamo ophakanyisiwe ungama-5mg / kg njengokwemfutho emangcwabeni ema-0, 2, naku-6 amasonto alandelwe umthamo wesondlo ka-5 mg / kg njalo emavikini ayisithupha. I-dose ephakanyisiwe iphinde ibe ngu-5 mg / kg ku-0, 2, nama-6 amasonto we-psoriatic arthritis, kodwa umthamo wesondlo ka-5 mg / kg unikezwa njalo emavikini angu-8. Ngokwe-arthritis ye-psoriatic, ingasetshenziswa noma ngaphandle kwe-methotrexate.
Ukusabela Okubi Okuvamile
Ukusabela okubi okuvame kakhulu, ngokususelwa ekuhlolweni kwemitholampilo yemikhiqizo ye-infliximab, kufaka izifo (ukuphefumula okuphezulu, isifo se-sinusitis, ne-pharyngitis), ukusabela okuhlobene nokukhipha (ukuphefumula, ukuqhuma, ukuphuza), ubuhlungu bekhanda, nobuhlungu besisu.
Ukungafani
I-Inflectra, kuma-dose amakhulu kunama-5 mg / kg, akufanele inikelwe iziguli ezinomthelela wokuhluleka kwenhliziyo. Futhi, i-Inflectra akufanele inikezwe iziguli eziye zabhekana nokusabela okukhulu kwe-hypersensitivity ku-Remicade (infliximab). I-Inflectra akufanele ihanjiswe kunoma ubani one-hypersensitivity eyaziwayo kunoma yiziphi izithako ezingasebenziyo ezidakamizwa noma eziphambeni zamaprotheni.
Izixwayiso
Kuye kwaqalwa izixwayiso nezinyathelo zokuqapha ukuqinisekisa ukuthi ukusetshenziswa okuphephile kwe-Inflectra. Lezo zixwayiso zihlanganisa:
- Ingozi yokuthuthukisa izifo ezimbi - I-Inflectra akufanele iphathwe ngesikhathi sokutheleleka okusebenzayo. Futhi, uma ukutheleleka kuqhubeka ngenkathi usebenzisa i-Inflectra, kufanele ihlolwe ngokucophelela futhi uma iba yingozi, i-Inflectra kufanele imiswe. Izifo ezingavamile (izifo ezenzeka kakhulu noma ezivame kakhulu kulabo abanamasosha omzimba obuthakathaka) ziye zabikwa ezigulweni eziphathwe nge-block block TNF. Futhi, ukuvuselelwa kwesifo sofuba noma ukutheleleka okusha kwesifo sofuba kwenzeke nokusetshenziswa kwemikhiqizo ye-infliximab.
- Izifo ezithathelwanayo ze-fungal - Uma isiguli senza isifo se-systemic ngenkathi isebenzisa i-Inflectra, ukwelashwa okuphathelene ne-fungal kufanele kucatshangelwe kulabo abahlala ezindaweni lapho izimo ze-fungal zikhona khona.
- Ukuhlukumezeka - Isigameko sezidakamizwa, kufaka phakathi i-lymphoma, sitholakale sikhulu kulabo abagulayo abaphathwa nge-TNF blockers kunokulawula. Ingozi / inzuzo yokusebenzisa i-Inflectra kufanele ihlolwe, ikakhulukazi ezigulini ezinezici ezithile emlandweni wazo wezokwelapha.
- Ukuguqulwa kwesifo se-Hepatitis B (HBV) - Iziguli kufanele zihlolwe igciwane le-Hepatitis B ngaphambi kokuqala i-Inflectra. Abathwali be-HBV kufanele baqashwe ngesikhathi nangemva kwezinyanga ezimbalwa ngemuva kokusebenzisa i-Inflectra. Uma ukuvuselelwa kwe-HBV kwenzeka, i-Inflectra kufanele isuswe futhi ukwelashwa okulwa negciwane kuqaliswe.
- I-hepatotoxicity - Kude kakhulu ukusabela okukhulu kwe-hepatic kungenzeka. Abanye bangase babulale noma badinga ukufakelwa kwesibindi. Ngokuthuthukiswa kwe-jaundice noma i- enzyme yesibindi ephakeme kakhulu, i-Inflectra kufanele imiswe.
- Ukungaphumeleli kwenhliziyo - Ukuhluleka kwenhliziyo entsha kokuqala noma izimpawu zokuhluleka kwenhliziyo ekhona kungenzeka ngokusetshenziswa kwe-Inflectra.
- I-Cytopenias - Kungase kube nokunciphisa inani lamaseli egazi ngokusetshenziswa kwe-Inflectra. Iziguli kufanele zifune ukunakekelwa kwezokwelapha uma izimpawu zikhula.
- I-Hypersensitivity - Ukusabela okukhulu kwe-infusion kungase kuthuthuke, kuhlanganise ne-anaphylaxis noma isifo sengqondo se-serum.
- Ukuhlaziya izifo - Ukuqala okusha noma ukukhukhuka kwezifo ezithintekayo zokudonswa komzimba kungenzeka ngokusetshenziswa kwe-Inflectra.
- I-Lupus-like syndrome - I-syndrome ehambisana nezimpawu ezifana ne- lupus ingaqala ngokusetshenziswa kwe-Inflectra. Isidakamizwa kufanele simiswe uma i-syndrome iqala.
- Imishanguzo ephilayo noma ama-agent aphethwe yizokwelapha - Akufanele futhi anikezwe nge-Inflectra. Izingane kufanele zisesikhathini sonke imithi ngaphambi kokuqala i-Inflectra. Uma usana lwaluvezwa ku-utero lwe-Inflectra noma lwe-infliximab, kufanele kube okungenani isikhathi esiyizinyanga ezingu-6 sokulinda emva kokuzalwa ngaphambi kokuba kunikezwe umgomo wokuphila.
I-Inflectra ithatha isixwayiso sebhokisi elimnyama ngokuphathelene nengozi ekhulayo yokutheleleka okujulile kanye ne-lymphoma, kanye nomyalelo wokuhlola isifo sofuba esifanele ngaphambi kokuqala umuthi.
Ukusebenzisana kwezidakamizwa
Ukuhlanganiswa kwe-Inflectra ne-anakinra noma i- Orencia (abatacept) ayinconywa. Ukusetshenziswa kwe- Actemra (tocilizumab) ne-Inflectra kufanele kugwenywe ngenxa yekhono lokukhulelwa kwe-immunosuppression nokwanda okukhulu kokutheleleka. I-Inflectra akufanele ihlanganiswe nezinye izidakamizwa ze-biologic .
Okubalulekile
Ama-Biosimilars asebelokhu ethuthukiswa iminyaka yokuthola i-rheumatoid arthritis. Ukuba ne-biosimilar yokuqala ekugcineni kuvunywe yi-FDA kuyinto enkulu. Ngokombono weziguli, ama-biosimilars anikeze ukhetho oluningi lwezokwelapha (lokho kuyinto enhle!) Futhi intengo kufanele ihambisane nezidakamizwa ze-biologic zangempela (enye into enhle!). Noma kunjalo, akuveli ngaphandle kwengxabano. Kube nokukhathazeka okuvezwe ngabanye abantu mayelana nokuthi ngabe izidakamizwa zizolingana yini ngempela. Cabanga ngegama elibizwa ngegama elibizwa ngegama elibizwa ngegama lomuthi - ingabe liphumelela ngokulinganayo? Lokhu kuxoxiswane ngamashumi eminyaka. I-FDA ithi "iziguli nabaqeqeshi bezempilo bazokwazi ukuthembela ekuphepheni nasekusebenzeni komkhiqizo we-biosimilar noma oshintshanayo, njengoba nje bebengayikhiqiza umkhiqizo." Eqinisweni, isidakamizwa se-biosimlar sivunyiwe ngokusekelwe ebufakazini "sifana kakhulu" nesidakamizwa sokubhekisela. Ingabe okufana kakhulu okufana nokulinganayo?
Kukhona esinye isigaba, lapho i-FDA idlala khona izidakamizwa eziguquguqukayo. Ngokusho kwe-FDA, "Umkhiqizo wezinto eziphilayo ongashintshashintshayo uwuphawu oluthile lomkhiqizo wesithenjwa ovunyelwe yi-FDA futhi uhlangabezana nemigomo eyengeziwe yokushintshaniswa. Umkhiqizo oguquguqukayo ongashintsha ungashintsha umkhiqizo wokubhekisisa ngaphandle kokungenelela komhlinzeki wezempilo owenzele umkhiqizo wokubhekisela. "
Mhlawumbe kudidekile kulesi sigaba. Njengalokhu njalo, iseluleko sethu ukuxoxisana nezidakamizwa nodokotela wakho noma u-rheumatologist. Kubalulekile futhi ukuba uzijwayele impendulo emphakathini we-rheumatology mayelana nokuvunyelwa kwe-Inflectra ne-biosimiliars yesikhathi esizayo. Funda lesi sitatimende kuJoan Von Feldt, MD, MSEd, uMongameli we-American College of Rheumatology.
> Imithombo:
Ulwazi lwe-Inflectra Ukubhala. 04/2016.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf
I-FDA ivumela i-Inflectra, i-biosimilar yokumisa. 04/05/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
Ulwazi olwama-Biosimilars. I-FDA. Kubuyekezwe 2/22/2016.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/
I-FDA ivumela uMkhiqizo wokuqala we-Biosimilar Zarxio. I-FDA. 03/06/2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm