Umbhali: Peter Berry
Umhla Wokudalwa: 12 Eyekhala 2021
Hlaziya Umhla: 13 Ucanzibe 2024
Anonim
Consumer Webinar - Abatacept (Orencia®) Shortage, 2 March 2022
Ividiyo: Consumer Webinar - Abatacept (Orencia®) Shortage, 2 March 2022

Umxholo

Yintoni uOrencia?

I-Orencia ligama lonyango elisebenzisa amayeza elisetyenziselwa ukunyanga le miqathango:

  • Isifo samathambo (RA). I-Orencia ivunyiwe ukuba isetyenziswe kubantu abadala abanomodareyitha ukuya kwi-RA esebenzayo. Ingathathwa yodwa okanye idityaniswe namanye amachiza asetyenziselwa ukunyanga i-RA.
  • I-Psoriatic arthritis (i-PsA). I-Orencia ivunyiwe ukuba isetyenziswe kubantu abadala abane-PsA. Ingathathwa yodwa okanye idityaniswe namanye amachiza asetyenziselwa ukunyanga iPSA.
  • Ulutsha lwe-idiopathic arthritis (JIA). I-Orencia ivunyiwe ukuba isetyenziswe kubantwana abaneminyaka emi-2 nangaphezulu ubudala ngokuphakathi ukuya kwi-JIA esebenzayo. Kule meko, i-Orencia inokusetyenziswa yodwa okanye ngokudibeneyo nelinye ichiza elibizwa ngokuba yi-methotrexate.

I-Orencia ine-abatacept yeziyobisi, esisisiyobisi se-biologic. I-Biologics yenziwe ngeeseli eziphilayo (ezinjengezo zivela kwizityalo okanye kwizilwanyana) kunakwimichiza.

I-Orencia iza ngeendlela ezimbini: ifom engamanzi kunye nefom. Unokuthatha amayeza ngenye yezi ndlela:


  • Ukufakwa ngaphakathi (IV). Ifom yefowder ye-Orencia isetyenziselwa ukwenza isisombululo esingamanzi esifakwe kwimithambo yakho. Le fomu ye-Orencia ifumaneka kumandla omnye: i-250 milligrams (mg).
  • Inaliti engaphantsi. Ifom yolwelo ye-Orencia itofwe phantsi kolusu lwakho. Le fomu ye-Orencia ifumaneka kumandla omnye: i-125 milligrams nge-milliliter (mg / mL).

Ukusebenza ngempumelelo

Kwizifundo zeklinikhi, i-Orencia yayisebenza ngokunyanga ukumodareyitha ukuya kwi-RA engqongqo. Xa usiwe kunye ne-methotrexate, u-Orencia usebenze kakuhle ekuphuculeni iimpawu zesi sifo. Kwezi zifundo, amanqaku e-ACR (abizwa ngegama leAmerican College of Rheumatology) ayesetyenziselwa ukulinganisa impendulo yabantu kunyango. Ukuba namanqaku e-ACR angama-20 kwakuthetha ukuba iimpawu zeRA zabantu zaziphuculwe ngama-20%.

Kubantu abathatha i-Orencia ngokudibanisa ne-methotrexate, i-62% ifikelele kumanqaku e-ACR angama-20 emva kweenyanga ezintathu. Kubantu abathatha i-methotrexate nge-placebo (unyango ngaphandle kwesiyobisi esisebenzayo), i-37% ineziphumo ezifanayo.


I-Orencia ikwasebenza kakuhle kubantu abathatha i-Orencia yodwa, ngaphandle kwe-methotrexate. Kulabo bathatha i-Orencia yodwa, ama-53% afikelela kumanqaku e-ACR angama-20 emva kweenyanga ezintathu. Kubantu abangakhange bafumane unyango nge-Orencia okanye i-methotrexate kodwa abathathe indawo ye-placebo, i-31% yaba neziphumo ezifanayo.

Ngolwazi oluthe kratya malunga nokusebenza kwe-Orencia yezinye iimeko, nceda ubone icandelo elithi "Orencia uses" icandelo elingezantsi.

I-Orencia generic

I-Orencia ifumaneka kuphela njengonyango lwegama lophawu. Okwangoku ayifumaneki kwifom ye-biosimilar.

Isilwanyana esine-biosimilar sinokuthelekiswa nesilwanyana esiqhelekileyo. Ichiza elenza lafana nelo lingumenzi ikopi yesiyobisi esiqhelekileyo (eso senziwe ngeekhemikhali). Iyeza elenziwa ngebhayosimili lenziwa lifane nesiyobisi se-biologic (esenziwe ngeeseli eziphilayo).

Zombini i-genics kunye ne-biosimilars zinokhuseleko olufanayo kunye nokusebenza njengechiza elenziwe ukuba likope. Kananjalo bathanda ukuhlawula iindleko ezingaphantsi kuneziyobisi.

Iziphumo ebezingalindelekanga ze-Orencia

I-Orencia inokubangela iziphumo ebezingalindelekanga ezinobulali okanye ezinobuzaza. Olu luhlu lulandelayo luqulathe ezinye zeziphumo eziphambili ezinokubakho ngelixa uthatha iOrencia. Olu luhlu alubandakanyi zonke iziphumo ebezingalindelekanga ezinokubakho.


Ngolwazi oluthe kratya malunga neziphumo ebezingalindelekanga zeOrencia, thetha nogqirha wakho okanye usokhemesti. Banokukunika iingcebiso malunga nendlela yokujongana nayo nayiphi na imiphumela emibi enokuthi ikhathaze.

Iziphumo eziqhelekileyo ezichaphazelekayo

Iziphumo eziqhelekileyo eziqhelekileyo ze-Orencia zingabandakanya:

  • usulelo oluphezulu lokuphefumla, njengokubanda okuqhelekileyo okanye usulelo lwesono
  • intloko ebuhlungu
  • isicaphucaphu

Uninzi lweziphumo ebezingalindelekanga zinokuhamba zingaphelanga iintsuku okanye iiveki ezimbalwa. Ukuba zinzima kakhulu okanye azihambi, thetha nogqirha wakho okanye usokhemesti.

Iziphumo ebezingalindelekanga ezimandundu

Iziphumo ezibi kakhulu ezivela e-Orencia aziqhelekanga, kodwa zinokwenzeka. Shayela ugqirha wakho ngokukhawuleza ukuba unemiphumo emibi. Tsalela umnxeba ku-911 ukuba iimpawu zakho ziziva zisongela ubomi okanye ukuba ucinga ukuba unempilo kaxakeka.

Iziphumo ebezingalindelekanga ezimandundu, ekuxoxwa ngazo apha ngezantsi “kwiinkcukacha zempembelelo yecala,” zinokubandakanya oku kulandelayo:

  • izifo ezinzulu, ezifana ne-pneumonia
  • negazi lakho kakhulu
  • ukuphinda kusebenze intsholongwane ye-hepatitis B (ukuvutha kwentsholongwane ukuba sele ingaphakathi komzimba wakho)
  • umhlaza

Iinkcukacha zesiphumo

Unokuzibuza ukuba zenzeka kangaphi iziphumo ebezingalindelekanga ngeli chiza, okanye nokuba ngaba ezinye iziphumo ebezingalindelekanga zinxulumene nalo. Nazi ezinye iinkcukacha kwiziphumo ebezingalindelekanga ezinokubangela okanye ezingabangeli.

Usulelo olubi

Unokuba nomngcipheko ophezulu wokufumana izifo ezinzulu ngelixa uthatha i-Orencia. Kungenxa yokuba iyeza lenza ukuba amajoni akho omzimba angakwazi ukukukhusela kwizifo.

Kwizifundo zeklinikhi, iipesenti ezingama-54 zabantu abathatha i-Orencia banesifo. Usulelo lwaluqwalaselwe njengolubi kwi-3% yabantu abathatha i-Orencia kwizifundo. Kulabo bathathe i-placebo (unyango ngaphandle kwesiyobisi esisebenzayo), i-48% yayinosulelo. Usulelo lwaluthathwa njengolubi kwi-1.9% yabantu abathathe i-placebo. Ezona zifo zixhaphake ngokuxhaphakileyo zichaphazele abantu emiphungeni, kulusu, kumchamo, kwikholoni nasezintso.

Iimpawu zosulelo zinokwahluka, kuxhomekeke kweliphi icandelo lomzimba wakho elichaphazelekayo. Banokubandakanya:

  • ifiva
  • ndiziva ndidiniwe kakhulu
  • ukukhohlela
  • Iimpawu ezinjengomkhuhlane
  • iindawo ezishushu, ezibomvu, okanye ezibuhlungu kulusu lwakho

Yazisa ugqirha wakho ukuba unempawu zosulelo. Banokucebisa iimvavanyo ezithile ukuze babone ukuba loluphi uhlobo losulelo onalo. Ukuba kuyimfuneko, baya kukunika amayeza ukunyanga usulelo lwakho.

Kwezinye iimeko, kunokuba nzima ukunyanga izifo ezinzulu ngelixa uthatha i-Orencia. Ukuba unentsholongwane, ugqirha wakho unokuncoma ukuba uyeke ukuthatha i-Orencia de kube isifo sakho siphelile.

Kwakhona, ugqirha wakho uya kufuna ukuqinisekisa ukuba awunaso isifo sephepha ngaphambi kokuba uqale ukuthatha i-Orencia. I-TB iyayichaphazela imiphunga yakho, kwaye isenokudala okanye ingabi nazimpawu. Xa ingabangeli zimpawu, usenokungazi ukuba unesifo. Ukwazi ukuba unesifo sephepha kuya kunceda oogqirha bakho baqonde ukuba i-Orencia ikhuselekile ukuba ungayisebenzisa.

Ukuphendula ngokuchaseneyo

Njengokuba kuninzi lweziyobisi, abanye abantu banokuphendula emva kokuthatha i-Orencia. Kwizifundo zeklinikhi, ngaphantsi kwe-1% yabantu abathatha i-Orencia babenempendulo engalunganga. Iimpawu zokuphendula kancinci kunokubandakanya:

  • irhashalala
  • ukucheba
  • ukucoca (ukufudumala nokubomvu kwesikhumba sakho)

Impendulo eyingozi kakhulu inqabile kodwa inokwenzeka. Iimpawu zokungaziphathi kakuhle kunokubandakanya:

  • ukudumba phantsi kolusu lwakho, ikakhulu kwiinkophe zakho, imilebe, izandla, okanye iinyawo
  • ukudumba kolwimi lwakho, umlomo, okanye umqala
  • ingxaki yokuphefumla

Biza ugqirha wakho ngoko nangoko ukuba unegciwane elibuhlungu e-Orencia. Tsalela umnxeba ku-911 ukuba iimpawu zakho ziziva zisongela ubomi okanye ukuba ucinga ukuba unempilo kaxakeka.

IHepatitis B

Ukuba unayo intsholongwane ye-hepatitis B (HBV) kwixesha elidlulileyo, unokuba semngciphekweni wentsholongwane ukuba ivule (isebenze kwakhona) ngelixa uthatha i-Orencia.

I-HBV sisifo esibindayo esibangelwa yintsholongwane. Abantu abane-HBV bahlala bethatha amayeza okulawula usulelo. Kodwa phantse akunakwenzeka ukuyicoca ngokupheleleyo intsholongwane emzimbeni wakho.

I-Orencia inokubangela ukuba i-HBV ivele emzimbeni wakho. Kungenxa yokuba i-Orencia inciphisa amandla omzimba wakho wokulwa usulelo. Ukuba intsholongwane iyaphinda isebenze, iimpawu zakho ze-HBV zinokubuya, kwaye imeko inokuba mandundu.

Iimpawu zosulelo lwe-HBV zinokubandakanya:

  • ukudinwa (ukunqongophala kwamandla)
  • ifiva
  • ukunciphisa ukutya
  • ndiziva ndibuthathaka
  • iintlungu kumalungu akho okanye izihlunu
  • ukungonwabi kwisisu sakho (isisu)
  • umchamo omnyama-mnyama
  • i-jaundice (tyheli kolusu lwakho okanye abamhlophe bamehlo akho)

Yazisa ugqirha wakho ngoko nangoko ukuba unayo nayiphi na impawu ye-HBV. Ugqirha wakho unokufuna ukuvavanya i-hepatitis B ngaphambi kokuba uqale i-Orencia. Ukuba unayo i-HBV, baya kuyinyanga le ntsholongwane ngaphambi kokuqala i-Orencia. Ukunyanga i-HBV kuya kunceda ukuba iimpawu zakho zihambe.

Umhlaza

Unokuba nomngcipheko okhulayo womhlaza ukuba uthatha i-Orencia. Eli chiza linokuchaphazela indlela ezisebenza ngayo iiseli zakho kwaye linokunyusa ukuba iiseli zakho zikhule ngokukhawuleza kwaye zande (zenze iiseli ezininzi). Ezi ziphumo zinokubangela umhlaza.

Kwizifundo zeklinikhi, i-1.3% yabantu abathatha i-Orencia baba nomhlaza. Kulawo angathathi i-Orencia, kodwa ngubani othathe indawo ye-placebo (unyango ngaphandle kwesiyobisi esisebenzayo), i-1.1% yaba neziphumo ezifanayo. Kwiimeko ezininzi, umhlaza uvele kwimiphunga yabantu nasegazini.

Ayaziwa ukuba umhlaza ubangelwe kukusebenzisa i-Orencia. Kungenzeka ukuba ezinye izinto zidlale indima kuphuhliso lwayo.

Iimpawu zomhlaza zinokwahluka ngokuxhomekeke kwindawo yomzimba wakho echaphazelekayo. Iimpawu zingabandakanya:

  • utshintsho lweeurological (ezinjengeentloko, ukuxhuzula, umbono okanye iingxaki zokuva, okanye ukukhubazeka ebusweni bakho)
  • ukopha okanye ukugruzuka ngokulula kunesiqhelo
  • ukukhohlela
  • ukudinwa (ukunqongophala kwamandla)
  • ifiva
  • ukudumba
  • amaqhuma
  • ukutyeba okanye ukwehla kobunzima

Tshela ugqirha wakho ukuba unempawu zomhlaza. Baza kucebisa iimvavanyo ezithile ukubona ukuba uphuhlisile na umhlaza. Ukuba unomdlavuza, baya kucebisa unyango kuwo. Baza kuphinda baxoxe nawe ukuba ngaba kukhuselekile na ukuba uthathe i-Orencia.

Ukudumba kolusu

Kwizifundo zeklinikhi, irhashalala ibingeyona mpembelelo imbi ebantwini abathatha i-Orencia. Kubantu abane-RA abathathe i-Orencia, iipesenti ezi-4 babenerhashalala ngexesha lokufunda. Kulabo bathathe indawo ye-placebo (unyango ngaphandle kwesiyobisi esisebenzayo), iipesenti ezi-3 ziye zanerhashalala. Ukuqhaqha kolusu kancinci kunokubakho kwindawo yomzimba wakho apho i-Orencia ifakwe khona.

Ngamanye amaxesha, irhashalala lolusu inokuba luphawu lokungalungeli komzimba. (Jonga icandelo elithi “Allergic reaction” apha ngasentla.)

Ukuba unerhashalala elingapheliyo ngelixa usebenzisa i-Orencia, xelela ugqirha wakho. Bazakuthetha nawe malunga nento enokubangela irhashalala lolusu lwakho. Banokubuza ukuba ngaba uneempawu zokungaziphathi kakuhle. Ukuba ngaba une-allergies reaction, ugqirha wakho uya kukuyalela amayeza okunciphisa iimpawu zokungabikho komzimba, kwaye banokuthi uyeke ukusebenzisa i-Orencia.

Ukutyeba kwakho (hayi isiphumo esisecaleni)

Ngexesha lezifundo zeklinikhi, ukuzuza ubunzima yayingenguye umphumo wecala kubantu abathatha i-Orencia.

Ukuba ukhathazekile malunga nokufumana ubunzima ngelixa usebenzisa i-Orencia, thetha nogqirha wakho.

Ukulahleka kweenwele (hayi isiphumo esisecaleni)

Kwizifundo zeklinikhi, ukulahleka kweenwele kwakungeyona mpembelelo ecaleni kubantu abathatha i-Orencia. Kodwa ukulahleka kweenwele kunokwenzeka kubantu abaneentlobo ezithile ze-arthritis, kubandakanywa nezo-Orencia ezingasetyenziselwa ukunyanga.

Yazisa ugqirha wakho ukuba unomdla wokulahleka kweenwele, okanye ukuba ulahlekile iinwele ngelixa usebenzisa i-Orencia. Banokucebisa iimvavanyo ukuzama ukuqonda ukuba kutheni kusenzeka kwaye banikeze iindlela zokukunceda ujongane nefuthe elisecaleni.

Ukudinwa (hayi isiphumo esisecaleni)

Ukukhathala (ukungabikho kwamandla) kwakungeyona mpembelelo ecaleni kubantu abathatha i-Orencia ngexesha lokufunda. Kodwa abanye abantu abaneentlobo ezahlukeneyo zesifo samathambo (ezinjengezo zisetyenziselwa ukunyanga i-Orencia) banokudinwa.

Tshela ugqirha wakho ukuba unokudinwa okungapheli ngelixa usebenzisa i-Orencia. Bayakucebisa iimvavanyo ezithile ukukunceda uqonde unobangela wokudinwa kwakho. Ukuba kukho imfuneko, banokuyalela amayeza ukunceda ukudinwa.

Orencia idosi

Umthamo we-Orencia ogqitywa ngugqirha wakho uya kuxhomekeka kwizinto ezininzi. Oku kubandakanya:

  • uhlobo kunye nobukhali bemeko oyisebenzisayo ukunyanga i-Orencia
  • ubunzima bakho
  • ifom ye-Orencia oyithathayo

Ngokwesiqhelo, ugqirha wakho uza kukuqala kumthamo oqhelekileyo. Emva koko baya kuyilungisa ngokuhamba kwexesha ukufikelela kwisixa esifanelekileyo kuwe. Ugqirha wakho uya kuthi ekugqibeleni anike idosi encinci enika isiphumo esifunayo.

Olu lwazi lulandelayo luchaza iidosi eziqhelekileyo ezisetyenziswayo okanye ezicetyiswayo. Nangona kunjalo, qiniseka ukuthatha idosi ekumisela ugqirha wakho. Ugqirha wakho uya kumisela eyona idosi ilungele iimfuno zakho.

Iifom zamachiza kunye namandla

I-Orencia iza ngeendlela ezimbini: umgubo kunye nolwelo. Ezi fom zinamandla ahlukeneyo.

Ifom yomgubo

Ifom yomgubo:

  • ifumaneka ngamandla omnye: 250 mg (milligrams)
  • Kuxutywe nolwelo ukwenza isisombululo osinikwa njenge-intravenous (IV) ukumnika (inaliti emthanjeni wakho onikwa ixesha elingaphezulu)

Ifom yotywala

Ifom yolwelo:

  • iyafumaneka kumandla omnye: 125 mg / mL (milligrams ngeemililitha)
  • unikwa inaliti engaphantsi kwesikhumba (inaliti phantsi kolusu lwakho)
  • iza iisirinji zeglasi ezikhethiweyo ezibambe i-0.4 mL, i-0.7 mL, kunye ne-1.0 mL yolwelo
  • iza ne-1-mL vial ebekwe kwisixhobo esibizwa ngokuba yi-ClickJect autoinjector

Isisombululo se-rheumatoid arthritis

Umthamo we-Orencia wesifo samathambo (RA) uxhomekeke kwindlela olithatha ngayo iyeza. Imilinganiselo yokufakwa ngaphakathi kwe-intravenous (IV) kunye nenaliti yangaphantsi ichazwe ngezantsi.

Ukufakwa ngaphakathi

Umthamo we-Orencia kuthomalaliso ngalunye lwe-IV luya kuxhomekeka kubunzima bomzimba wakho. Umthamo oqhelekileyo we-Orencia ngu:

  • I-500 mg yabantu abanobunzima obungaphantsi kweekhilogram ezingama-60 (malunga neepawundi ezili-132)
  • I-750 mg yabantu abanobunzima be-60 ukuya kwi-100 kilogram (malunga ne-132 ukuya kwi-220 yeepawundi)
  • I-1,000 mg yabantu abanobunzima obungaphezulu kwe-100 kilogram (malunga neepawundi ezingama-220)

Ukumiliselwa kwe-IV nganye kuya kuhlala malunga nemizuzu engama-30.

Emva kwedosi yakho yokuqala ye-Orencia, uya kunikwa amathamo amabini ngaphezulu rhoqo kwiiveki ezi-2. Emva koko, idosi nganye inikwa iiveki ezi-4 zonke.

Inaliti engaphantsi

Umthamo oqhelekileyo we-Orencia ngenaliti engaphantsi kwe-125 mg kanye ngeveki.

Inaliti yakho yokuqala engaphantsi inokuthi okanye inganikwa emva kokuba ufumane idosi yangaphambili ye-Orencia ngokufakwa kwe-IV. Ukuba ngaba une-IV infusion ye-Orencia, uya kuthatha inaliti yakho yokuqala engaphantsi kwangaphambi konyango lwakho lwe-IV.

Isisombululo se-psoriatic arthritis

Umthamo we-Orencia ye-psoriatic arthritis (i-PsA) ixhomekeke kwindlela olithatha ngayo eli chiza. Imilinganiselo yokufakwa ngaphakathi kwe-intravenous (IV) kunye nenaliti yangaphantsi iyahlolwa apha ngezantsi.

Ukufakwa ngaphakathi

Umthamo we-Orencia kuthomalaliso ngalunye lwe-IV luya kuxhomekeka kubunzima bomzimba wakho. Umthamo oqhelekileyo we-Orencia ngu:

  • 500 mg kwabo banobunzima obungaphantsi kweekhilogram ezingama-60 (malunga neepawundi ezili-132)
  • I-750 mg yabo inobunzima obungama-60-100 eekhilogram (malunga ne-132 ukuya kuma-220 eepawundi)
  • I-1,000 mg kwabo banobunzima obungaphezulu kwe-100 kilogram (malunga neepawundi ezingama-220)

Ukumiliselwa kwe-IV nganye kuya kuhlala malunga nemizuzu engama-30.

Emva kwedosi yakho yokuqala ye-Orencia, uya kunikwa amathamo amabini ngaphezulu rhoqo kwiiveki ezi-2. Emva koko, idosi nganye inikwa iiveki ezi-4 zonke.

Inaliti engaphantsi

Umthamo oqhelekileyo we-Orencia ngenaliti engaphantsi kwe-125 mg kanye ngeveki.

Isisombululo se-juvenile idiopathic arthritis

Umthamo we-Orencia yolutsha idiopathic arthritis (JIA) uqobo ixhomekeke kwindlela olithatha ngayo iyeza. Imilinganiselo yokufakwa ngaphakathi kwe-intravenous (IV) kunye nokufakwa kwenaliti engaphantsi kuyahlaziywa apha ngezantsi.

Ukufakwa ngaphakathi

Umthamo we-Orencia kuthomalaliso ngalunye lwe-IV unokuxhomekeka kubunzima bomzimba wakho okanye bomntwana wakho. Umthamo oqhelekileyo we-Orencia kubantwana abaneminyaka emi-6 nangaphezulu ubudala:

  • 10 mg / kg (milligrams of drug per kilogram of weight weight) kwabo banobunzima obungaphantsi kwama-75 eekhilogram (malunga neeponti ezili-165)
  • I-750 mg yabo inobunzima obuziikhilogram ezingama-75 kunye neekhilogram ezili-100 (malunga neekhilogram ezili-165 ukuya kuma-220 eekhilogram)
  • I-1,000 mg yabo inobunzima obungaphezu kwe-100 kg (malunga neepawundi ezingama-220)

Umzekelo, umntu onobunzima obungama-50 eekhilogram (malunga neepawundi ezili-110) uya kuthatha i-500 mg ye-Orencia. Le yimiligram ezili-10 zamachiza ngekhilogram nganye yomzimba.

Emva kwedosi yakho yokuqala okanye ye-Orencia, ezinye iidosi ezimbini ziya kunikwa rhoqo kwiiveki ezi-2. Emva koko, idosi nganye inikwa iiveki ezi-4 zonke.

Ulawulo lwe-IV lwe-Orencia alukhuthazwa kubantwana abangaphantsi kweminyaka emi-6 ubudala.

Inaliti engaphantsi

Umthamo we-Orencia ngenaliti engaphantsi iya kuxhomekeka kubunzima bomzimba wakho okanye bomntwana wakho. Umthamo oqhelekileyo we-Orencia kubantwana abaneminyaka emi-2 nangaphezulu ubudala:

  • 50 mg kwabo banobunzima beekhilogram ezili-10 ukuya ngaphantsi kweekhilogram ezingama-25 (malunga neekhilogram ezingama-22 ukuya ngaphantsi kweepounds ezingama-55)
  • I-87.5 mg yabo inobunzima beekhilogram ezingama-25 ukuya ngaphantsi kweekhilogram ezingama-50 (malunga neekhilogram ezingama-55 ukuya ngaphantsi kweepounds ezili-110)
  • I-125 mg yabo inobunzima obungama-50 eekhilogram okanye nangaphezulu (malunga neepawundi ezili-110 okanye nangaphezulu)

Kubantu abaneminyaka emi-6 nangaphezulu, inaliti yabo yokuqala ye-Orencia inokuthi okanye inganikwa emva kokuba befumene ukumiliselwa kwe-IV kweziyobisi. Ukuba ukufakwa kwe-IV kwe-Orencia sele kunikiwe, inaliti yokuqala yangaphambi kwesikhumba inikwa ngosuku olulandelayo emva kokufakwa kwe-IV.

Idosi yabantwana

Umthamo ocetyiswayo we-Orencia uyahluka ngokuxhomekeka kwindlela ethathwe ngayo kunye nobunzima bomzimba womntu oyithathayo. Ngolwazi oluthe kratya malunga nedosi ebantwaneni, jonga icandelo le- "Idosi yesifo samathambo esencinci".

Kuthekani ukuba ndiphose idosi?

Into oza kuyenza yedosi ephosiweyo ixhomekeke kwindlela oyithatha ngayo i-Orencia. Kodwa kuwo omabini la matyala, izikhumbuzo zamayeza zinokukunceda uqiniseke ukuba awuphosi idosi.

Ukufakwa ngaphakathi

Ukuba uphulukene nokuqeshwa kwi-IV ukumnika i-Orencia, tsalela iklinikhi yakho yezonyango kwangoko. Baza kucwangcisela ixesha elitsha ukuze ufumane unyango lwakho lwe-Orencia IV.

Inaliti engaphantsi

Ukuba uphosa inaliti engaphantsi yeOrencia, tsalela ugqirha kwangoko. Baza kukunceda wenze ishedyuli entsha yokulandela.

Ngaba kuya kufuneka ndisebenzise eli chiza ixesha elide?

Mhlawumbi uya kuthanda. Iimeko ezisetyenziselwa ukunyanga i-Orencia ukunyanga zizifo ezingapheliyo (zexesha elide). I-Orencia inokusetyenziswa ixesha elide kunyango ukuba wena nogqirha wakho niziva ukuba iyeza likhuselekile kwaye liyanisebenzela.

UOrencia usebenzisa

Ulawulo lokutya kunye neziyobisi (i-FDA) livuma amayeza amiselweyo anjengeOrencia ukunyanga iimeko ezithile. I-Orencia yamkelwe yi-FDA ukunyanga iintlobo ezintathu ezahlukeneyo zesifo samathambo: isifo samathambo, i-psoriatic arthritis kunye ne-juvenile idiopathic arthritis.

I-Orencia yesifo samathambo

I-Orencia yamkelwe yi-FDA ukuba inyange i-rheumatoid arthritis (RA) kubantu abadala. Isetyenziswa ikakhulu kubantu abadala abaneempawu eziqhubekayo zesi sifo.

I-RA sisifo esizimelayo esibangela ukonakala kumalungu akho. Iimpawu zeRA zinokubandakanya iintlungu, ukudumba, kunye nokuqina komzimba wakho wonke.

I-Orencia icetyiswa ziingcali njengonyango lweRA. Ugqirha wakho unokufuna ukuba uyisebenzise wedwa okanye ngokudibanisa namanye amachiza, kubandakanya i-methotrexate. La machiza ngamanye amaxesha abizwa ngokuba sisifo esiguqula i-antirheumatic drug (DMARDs).

Ukusebenza kwesifo samathambo

Kwisifundo esinye seklinikhi, i-Orencia yanikwa i-methotrexate kubantu abangama-424 abane-RA yokumodareyitha ukuya kwi-RA. I-Orencia yanikwa ngokufakwa ngaphakathi (IV) ukumiliselwa (inaliti kwimithambo yabantu). Kulabo bathatha i-Orencia, iipesenti ezingama-62 zabantu babenonciphiso lwe-20% kwiimpawu zabo ze-RA emva kweenyanga ezintathu zonyango. Kulabo bathatha indawo ye-placebo (unyango ngaphandle kwesiyobisi esisebenzayo) nge-methotrexate, i-37% ineziphumo ezifanayo.

Olunye uphononongo lweklinikhi lujonge unyango lwe-Orencia kubantu abane-RA. Abantu banikwa zombini i-Orencia kunye ne-methotrexate. Kodwa kolu phononongo, indibaniselwano yamayeza yanikwa ngenaliti engaphantsi (inaliti phantsi kolusu lwabantu) kwiqela elinye. Kwaye elinye iqela lanikwa amayeza ngokufakwa kwe-IV.

Emva kweenyanga ezintathu zonyango, i-68% yabantu abathatha amayeza ngenaliti yangaphantsi banokuncipha okungama-20% kwiimpawu zabo zeRA. Oku kuthelekiswa ne-69% yabantu abathathe amayeza ngokufakwa ngaphakathi.

I-Orencia ye-psoriatic arthritis

I-Orencia yamkelwe yi-FDA ukunyanga abantu abadala abane-psoriatic arthritis (PsA). Isetyenziswa ikakhulu kubantu abaneempawu eziqhubekayo zesi sifo. Ngapha koko, iingcebiso zangoku zeengcali zicebisa ukusebenzisa i-Orencia kwaba bantu.

I-PsA luhlobo lwe-arthritis olwenzeka kubantu abane-psoriasis. Iimpawu zale meko zibandakanya ukubomvu, isikhumba esikrwada, kunye namalungu adumbileyo.

Ukusebenza ngempumelelo kwe-psoriatic arthritis

Kwisifundo esinye seklinikhi, i-Orencia yanikwa abantu abangama-40 abane-PsA besebenzisa ukumiliselwa kwe-intravenous (IV) (inaliti emthanjeni wabo). Emva kweeveki ezingama-24 zonyango, i-47.5% yabantu abathatha i-Orencia banokuncipha okungama-20% kwiimpawu zabo ze-PsA. Kulabo bathatha indawo ye-placebo (unyango ngaphandle kwesiyobisi esisebenzayo), i-19% ibe neziphumo ezifanayo.

Kwesinye isifundo seklinikhi, i-Orencia yanikwa abantu abangama-213 abane-PsA besebenzisa inaliti engaphantsi (inaliti phantsi kolusu). Emva kweeveki ezingama-24 zonyango, i-39.4% yabo bathathe i-Orencia ubuncinci banciphise i-20% kwiimpawu zabo ze-PsA. Kulabo bathatha i-placebo (unyango ngaphandle kwesiyobisi esisebenzayo), i-22.3% ineziphumo ezifanayo.

I-Orencia yolutsha lwe-idiopathic arthritis

I-Orencia ivunyiwe yi-FDA ukuba inyange ngokuphakathi ukuya kwinqanaba elisebenzayo le-juvenile idiopathic arthritis (JIA). Le meko yeyona ndlela ixhaphakileyo yesifo samathambo ebantwaneni. Kubangela iintlungu ezidibeneyo, ukudumba, kunye nokuqina.

I-Orencia kufuneka isetyenziswe ebantwaneni apho i-JIA ichaphazela uninzi lwamalungu abo omzimba. Yamkelwe ukusetyenziswa kubantwana abaneminyaka emi-2 nangaphezulu.

Iingcali ngoku zicebisa ukusebenzisa i-Orencia kwaba bantu. Iyeza linokusetyenziswa lilodwa okanye ngokudibeneyo ne-methotrexate.

Ukusebenza ngempumelelo kolutsha lwe-idiopathic arthritis

Kwisifundo esinye seklinikhi, u-Orencia wanikwa abantwana abali-190 abane-JIA ababeneminyaka emi-6 ukuya kweli-17 ubudala. Abantwana bafumana u-Orencia ngokufakwa ngaphakathi (IV) ngenaliti (ngenaliti emthanjeni wabo). Uninzi lwabantwana lukwafumene imethotrexate. Ukuphela kwesifundo, iipesenti ezingama-65 zabantwana abathatha i-Orencia ubuncinci banciphise i-30% kwiimpawu zabo ze-JIA.

Kwesinye isifundo seklinikhi, u-Orencia wanikwa ngenaliti yangaphantsi (inaliti phantsi kolusu) kubantwana abangama-205 abaneJIA. Abantwana ngaphambili babekhe bafumana amanye amayeza okunyanga i-JIA yabo, kodwa babesenazo iimpawu zale meko. Ukuphela kwesifundo, i-Orencia yayisebenza ngokunciphisa iimpawu ze-JIA. Iziphumo zolu phononongo zazifana neziphumo zesifundo sokufakwa kwe-IV.

IOrencia yezinye iimeko

Unokuzibuza ukuba i-Orencia isetyenziselwa ezinye iimeko. Apha ngezantsi kukho iimeko apho ngamanye amaxesha iOrencia inokusetyenziswa ngaphandle kwelebheli ukunyanga. Ukusetyenziswa kwelebheli engasebenziyo kuthetha ukuba ichiza lisetyenziselwa ukunyanga imeko nangona ayivunyelwanga yi-FDA ukwenza njalo.

I-Orencia yelupus (ukusetyenziswa kwelebula engekho)

I-Orencia ayivunyelwanga yi-FDA ukunyanga i-lupus, kodwa ngamanye amaxesha isetyenziselwa ngaphandle kwelebheli yale meko.

Ezinye iingcali zikholelwa ukuba i-Orencia ingaluncedo ekunciphiseni iimpawu zelupus. Kodwa izifundo zeklinikhi zamva nje khange zikwazi ukubonisa ukuba i-Orencia iyiphucula njani le meko. Ulwazi oluthe kratya luyafuneka ukwazi ngokuqinisekileyo ukuba i-Orencia ikhuselekile kwaye iyasebenza ekusebenziseni kubantu abane-lupus.

Thetha nogqirha wakho ukuba unelupus kwaye unomdla wokuthatha i-Orencia. Baza kuxoxa ngeendlela zokhetho kunye nawe kwaye bakunike amayeza akhuselekileyo kwaye asebenzayo kuwe.

I-Orencia ye-ankylosing spondylitis (phantsi kwesifundo)

I-Orencia ayivunyelwanga yi-FDA ukunyanga i-ankylosing spondylitis (AS). Kwakhona, iingcali azikukhuthazi ukusebenzisa ichiza ukunyanga esi sifo.

Kodwa ezinye izifundo zenziwa ukuvavanya ukuba i-Orencia inokuyiphatha njani i-AS. Ulwazi oluthe kratya luyafuneka ukwazi ngokuqinisekileyo ukuba ichiza likhuselekile kwaye liyasebenza na ukunyanga i-AS.

Thetha nogqirha wakho ukuba unayo i-AS kwaye unomdla wokuthatha i-Orencia. Baza kuxoxa ngembali yakho yonyango kwaye bacebise olona nyango lulungileyo kuwe.

I-Orencia yabantwana

I-Orencia ivunyiwe yi-FDA ukuba isetyenziswe kubantwana abanomodareyitha ukuya kubunzima be-juvenile idiopathic arthritis (JIA). Ngolwazi oluthe kratya, jonga i "Orencia yentsha ye-idiopathic arthritis" icandelo elingentla.

Ukusetyenziswa kwe-Orencia nezinye iziyobisi

I-Orencia inokusetyenziswa yodwa okanye ngokudibeneyo namanye amachiza. Ugqirha wakho uya kukucebisa ukuba ufuna ukuthatha amanye amayeza kunye ne-Orencia ukunyanga imeko yakho. Oku kunokwenzeka ukuba kwenzeke kubantu abane-rheumatoid arthritis okanye i-juvenile idiopathic arthritis.

I-Orencia namanye amayeza e-rheumatoid arthritis

I-Orencia yamkelwe yi-FDA ukunyanga abantu abadala abanomodareyitha ukuya kwi-rheumatoid arthritis esebenzayo. Iyeza linokusetyenziswa lilodwa okanye ngokudibeneyo namanye amayeza. Nangona kunjalo, ukuba isetyenziswe kunye nezinye iziyobisi, ezo ziyobisi akufanele zibe zeqela leziyobisi ezibizwa ngokuba yi-anti-TNFs. (Jonga icandelo le "Orencia interaction" icandelo elingezantsi ngolwazi oluthe kratya.)

Kwizifundo zeklinikhi, i-Orencia yasebenza kakuhle xa yathathwa namanye amayeza ngabantu abadala abane-moderation ukuya kwi-RA engqongqo. Amachiza aqhelekileyo anikwe i-Orencia yayilutshintsho lwezifo kwi-antirheumatic drug (DMARDs), kubandakanya i-methotrexate.

I-Orencia namanye amachiza e-juvenile idiopathic arthritis

I-Orencia yamkelwe yi-FDA ukunyanga abantwana abane-juvenile idiopathic arthritis (JIA). Iyeza livunyiwe ukuba lisetyenziswe lilodwa okanye ngokudibeneyo ne-methotrexate.

Kwizifundo zeklinikhi, u-Orencia wasebenza kakuhle ukunyanga i-JIA ebantwaneni xa iyeza lalinikwa nge-methotrexate. Ngenxa yoko, iingcali ngoku zicebisa ukuba i-Orencia isetyenziswe kunye ne-methotrexate kunokuba iyodwa ukunyanga i-JIA.

Ezinye iindlela zokuya e-Orencia

Amanye amachiza akhoyo anokuyinyanga imeko yakho. Abanye banokukulungela ngcono kunabanye. Ukuba unomdla wokufumana enye i-Orencia, thetha nogqirha wakho. Banokukuxelela ngamanye amayeza anokukusebenzela.

Phawula: Amanye amachiza adweliswe apha asetyenziswa ngaphandle kwelebheli ukunyanga le miqathango.

Ezinye iindlela zesifo samathambo

Imizekelo yezinye iziyobisi ezinokusetyenziselwa ukunyanga isifo samathambo (RA) zibandakanya:

  • imethotrexate (iOtrexup, iRasuvo, iTrexall, iXatmep)
  • isulfasalazine (Azulfidine, Azulfidine EN)
  • ihydroxychloroquine (iPlaquenil)
  • adalimumab (Humira)
  • isatifikethi sepgol (Cimzia)
  • I-etanercept (i-Enbrel)
  • igolimumab (iSimponi)
  • infliximab (Remicade, Inflectra, Renflexis)
  • Tofacitinib (Xeljanz)

Olunye unyango lwe-psoriatic arthritis

Imizekelo yezinye iziyobisi ezingasetyenziselwa ukunyanga i-psoriatic arthritis (PsA) zibandakanya:

  • imethotrexate (iOtrexup, iRasuvo, iTrexall, iXatmep)
  • isulfasalazine (Azulfidine, Azulfidine EN)
  • I-cyclosporine (iGengraf, iNeoral, iSandimmune)
  • leflunomide (Arava)
  • I-apremilast (i-Otezla)
  • adalimumab (Humira)
  • isatifikethi sepgol (Cimzia)
  • I-etanercept (i-Enbrel)
  • igolimumab (iSimponi)
  • infliximab (Remicade, Inflectra, Renflexis)
  • ustekinumab (uStelara)
  • secukinumab (iCosentyx)
  • ixekizumab (iTaltz)
  • brodalumab (uSiliq)
  • Tofacitinib (Xeljanz)

Ezinye iindlela zentsholongwane ye-idiopathic arthritis

Imizekelo yezinye iziyobisi ezinokusetyenziselwa ukunyanga i-juvenile idiopathic arthritis (JIA) ibandakanya:

  • imethotrexate (iOtrexup, iRasuvo, iTrexall, iXatmep)
  • isulfasalazine (Azulfidine, Azulfidine EN)
  • leflunomide (Arava)
  • adalimumab (Humira)
  • I-etanercept (i-Enbrel)
  • igolimumab (iSimponi)
  • infliximab (Remicade, Inflectra, Renflexis)
  • tocilizumab (Actemra)

I-Orencia ngokuchasene neHumira

Unokuzibuza ukuba i-Orencia ithelekisa njani namanye amayeza amiselwe ukusetyenziswa okufanayo. Apha sijonga indlela iOrencia neHumira ezifanayo kwaye ezahlukeneyo.

Ngokubanzi

I-Orencia ine-abatacept yeziyobisi. I-Humira iqulethe ichiza i-adalimumab. Ezi ziyobisi zisebenza ngokwahlukileyo emzimbeni wakho, kwaye zezeklasi ezahlukeneyo zamachiza.

Sebenzisa

I-Orencia neHumira zombini zivunyiwe yi-Food and Drug Administration (FDA) ukunyanga i-rheumatoid arthritis (RA) kunye ne-psoriatic arthritis (PsA) kubantu abadala. La machiza ayamkelwa ukuba anyange i-juvenile idiopathic arthritis (JIA) kubantwana abaneminyaka emi-2 nangaphezulu.

I-Humira ikwavunyiwe yi-FDA ukunyanga le miqathango ilandelayo:

  • i-ankylosing spondylitis kubantu abadala
  • Isifo sikaCrohn kubantu abadala nakubantwana abaneminyaka emi-6 nangaphezulu
  • ulcerative colitis kubantu abadala
  • I-plaque psoriasis kubantu abadala
  • i-hidradenitis suppurativa kubantu abadala kunye nabantwana abaneminyaka eli-12 nangaphezulu
  • I-uveitis kubantu abadala kunye nabantwana abaneminyaka emi-2 nangaphezulu

Iifom zeziyobisi kunye nolawulo

I-Orencia iza ngeendlela ezimbini, ezinamandla ahlukeneyo. Ezi fomu zezi zilandelayo:

  • ifom yomgubo
    • ifumaneka ngamandla omnye: 250 mg (milligrams)
    • Kuxutywe nolwelo ukwenza isisombululo osinikwa njenge-intravenous (IV) ukumnika (inaliti emthanjeni wakho onikwa ixesha elingaphezulu)
  • uhlobo lolwelo
    • iyafumaneka kumandla omnye: 125 mg / mL (milligrams ngeemililitha)
    • unikwa inaliti engaphantsi kwesikhumba (inaliti phantsi kolusu lwakho)
    • iza iisirinji zeglasi ezikhethiweyo ezibambe i-0.4 mL, i-0.7 mL, kunye ne-1.0 mL yolwelo
    • iza ne-1-mL vial ebekwe kwisixhobo esibizwa ngokuba yi-ClickJect autoinjector

I-Humira iza njengesisombululo esinikwa ngenaliti engaphantsi (inaliti phantsi kolusu lwakho). Iyafumaneka kula mandla mabini alandelayo:

  • 100 mg / mL: iza ngeebhotile ezibambe i-0.8 mL, 0.4 mL, 0.2 mL, kunye ne-0.1 mL yesisombululo
  • 50 mg / mL: iza kwiibhotile ezibambe i-0.8 mL, 0.4 mL, kunye ne-0.2 mL yesisombululo

Iziphumo kunye neengozi

I-Orencia neHumira ziqulathe iziyobisi ezahlukeneyo. Kodwa omabini la mayeza ayayichaphazela indlela amajoni akho omzimba asebenza ngayo. Ke ngoko, omabini la mayeza anokubangela iziphumo ezifanayo. Apha ngezantsi kunemizekelo yeziphumo ebezingalindelekanga.

Iziphumo eziqhelekileyo ezichaphazelekayo

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga eziqhelekileyo ezinokuthi zenzeke nge-Orencia, neHumira, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka nge-Orencia:
    • isicaphucaphu
  • Ngaba kunokwenzeka ngeHumira:
    • Ukuphendula kolusu kwindawo ejikeleze indawo yakho yenaliti
    • irhashalala
  • Inokwenzeka kunye ne-Orencia kunye neHumira:
    • usulelo oluphezulu lokuphefumla, njengokubanda okuqhelekileyo okanye usulelo lwesono
    • intloko ebuhlungu

Iziphumo ebezingalindelekanga ezimandundu

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokubakho nge-Orencia, kunye neHumira, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka nge-Orencia:
    • izifo ezinzulu, ezifana ne-pneumonia
  • Ngaba kunokwenzeka ngeHumira:
    • iingxaki kunye nenkqubo yakho ye-nervous (ukuphazamiseka okanye ukubetha, utshintsho kumbono wakho, ubuthathaka kwiingalo zakho okanye emilenzeni, okanye utywala)
    • amanqanaba asezantsi iiseli ezithile zegazi, ezinjengeeseli ezimhlophe zegazi kunye neeplatelets
    • iingxaki zentliziyo, ezinje ngokusilela kwentliziyo
    • usulelo olubi, njengesifo sephepha (TB) *
    • iingxaki zesibindi, ezinje ngokusilela kwesibindi
  • Inokwenzeka kunye ne-Orencia kunye neHumira:
    • izifo ezinzulu
    • umhlaza *
    • ukuphinda kusebenze intsholongwane ye-hepatitis B (ukuvutha kwentsholongwane ukuba sele ingaphakathi komzimba wakho)
    • negazi lakho kakhulu

Ukusebenza ngempumelelo

Zombini i-Orencia kunye neHumira zivunyiwe yi-FDA ukunyanga isifo samathambo, i-psoriatic arthritis, kunye ne-juvenile idiopathic arthritis. Ukusebenza kwawo omabini la machiza ekunyangeni ezi meko kuthelekiswa apha ngezantsi.

Ukusebenza kakuhle kunyango lwe-rheumatoid arthritis

I-Orencia neHumira ngokuthelekiswa ngokuthe ngqo kuphononongo lweklinikhi njengeendlela zonyango ze-rheumatoid arthritis (RA).

Kolu phononongo, abantu abadala abangama-646 abanomodareyitha ukuya kwi-RA enzima babethatha i-Orencia okanye i-Humira: Abantu abangama-318 bathatha i-Orencia, ngelixa abantu abangama-328 bathatha uHumira. Omabini la maqela abantu athathe i-methotrexate. Emva kweminyaka emibini yonyango, omabini la machiza ayesebenza ngokulinganayo kunyango lwe-RA.

Kulabo bathatha i-Orencia, i-59.7% yabantu ubuncinci banciphise i-20% kwiimpawu zabo ze-RA. Kubantu abathatha i-Humira, i-60.1% yayineziphumo ezifanayo.

Ukusebenza ngokunyanga i-psoriatic arthritis

U-Orencia noHumira abakhange bathelekiswe ngokuthe ngqo kwizilingo zeklinikhi njengeendlela zonyango ze-psoriatic arthritis (PsA). Kodwa izifundo ezahlukileyo zifumanise ukuba omabini la machiza ayasebenza ukunyanga le meko.

Ukusebenza ngokunyanga i-juvenile idiopathic arthritis

U-Orencia noHumira babethelekiswa kuphononongo lwezifundo njengeendlela zonyango zonyango lwe-juvenile idiopathic arthritis (JIA). Emva kolu hlaziyo, iingcali zifumanise ukuba omabini la machiza anokukhuseleko kunye nokusebenza ngokufanayo.

Iindleko

I-Orencia neHumira bobabini abasebenzisa iziyobisi. Okwangoku azikho iifom ze-biosimilar ze-Orencia ezikhoyo. Isilwanyana esine-biosimilar sinokuthelekiswa nesilwanyana esiqhelekileyo. Ichiza elenza lafana nelo lingumenzi ikopi yesiyobisi esiqhelekileyo (eso senziwe ngeekhemikhali). Iyeza elenziwa ngebhayosimili lenziwa lifane nesiyobisi se-biologic (esenziwe ngeeseli eziphilayo).

Iyeza elilingana ne-biosimilar ku-Humira liyafumaneka kwifomu enikwa ngokufakwa ngaphakathi (IV). Iingcali zicebisa ukusebenzisa ii-biosimilars ukunyanga i-RA, i-PsA, kunye ne-JIA xa ikhuselekile kwaye isebenza kwimeko yakho. Thetha nogqirha wakho ukuze ufumane ukuba i-biosimilar ikulungele na.

Amayeza egama leBrand ahlala exabisa ngaphezulu kweendleko zeziyobisi ze-biosimilar.

Ngokwengqikelelo yeGoodRx.com, i-Humira ibiza imali encinci kune-Orencia. Elona xabiso uzakuhlawula ngalo naliphi na ichiza lixhomekeke kwisicwangciso sakho seinshurensi, indawo okuyo, kunye nekhemesti oyisebenzisayo.

I-Orencia vs. i-Enbrel

Unokuzibuza ukuba i-Orencia ithelekisa njani namanye amayeza amiselwe ukusetyenziswa okufanayo. Apha sijonga indlela i-Orencia kunye ne-Enbrel ezifanayo kunye ezahlukeneyo.

Ngokubanzi

I-Orencia ine-abatacept yeziyobisi. I-Enbrel iqulethe iziyobisi etanercept. La machiza ngamacandelo ahlukeneyo amayeza, kwaye asebenza ngokwahlukileyo emzimbeni wakho.

Sebenzisa

I-Orencia ne-Enbrel yamkelwe yi-Food and Drug Administration (i-FDA) ukunyanga isifo samathambo (RA) kunye ne-psoriatic arthritis (PsA) kubantu abadala. Omabini la machiza ayamkelwa ukuba anyange i-juvenile idiopathic arthritis (JIA) kubantwana abaneminyaka emi-2 nangaphezulu.

I-Enbrel ikwavunyiwe yi-FDA ukunyanga ezinye iimeko ezimbini:

  • i-ankylosing spondylitis kubantu abadala
  • I-plaque psoriasis kubantu abadala kunye nabantwana abaneminyaka emi-4 nangaphezulu

Iifom zeziyobisi kunye nolawulo

I-Orencia iza ngeendlela ezimbini, ezinamandla ahlukeneyo. Ezi fomu zezi zilandelayo:

  • ifom yomgubo
    • ifumaneka ngamandla omnye: 250 mg (milligrams)
    • Kuxutywe nolwelo ukwenza isisombululo osinikwa njenge-intravenous (IV) ukumnika (inaliti emthanjeni wakho onikwa ixesha elingaphezulu)
  • uhlobo lolwelo
    • iyafumaneka kumandla omnye: 125 mg / mL (milligrams ngeemililitha)
    • unikwa inaliti engaphantsi kwesikhumba (inaliti phantsi kolusu lwakho)
    • iza iisirinji zeglasi ezikhethiweyo ezibambe i-0.4 mL, i-0.7 mL, kunye ne-1.0 mL yolwelo
    • iza ne-1-mL vial ebekwe kwisixhobo esibizwa ngokuba yi-ClickJect autoinjector

I-Enbrel inikwa ngenaliti engaphantsi. Iza kwezi ndlela zilandelayo:

  • ifom yomgubo
    • ifumaneka ngamandla omnye: 25 mg
    • uxutywe nolwelo ukwenza isisombululo
  • uhlobo lolwelo
    • ifumaneka ngamandla omnye: 50 mg / mL
    • iza ngeebhotile ezibambe i-0.5 mL kunye ne-1.0 mL yolwelo

Iziphumo kunye neengozi

I-Orencia ne-Enbrel iqulethe iziyobisi ezahlukeneyo. Kodwa omabini la machiza ayasebenza kumajoni akho omzimba. Ke ngoko, omabini la mayeza anokubangela iziphumo ezifanayo. Apha ngezantsi kunemizekelo yeziphumo ebezingalindelekanga.

Iziphumo eziqhelekileyo ezichaphazelekayo

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga eziqhelekileyo ezinokuthi zenzeke nge-Orencia okanye nge-Enbrel.

  • Ngaba kunokwenzeka nge-Orencia:
    • usulelo, ezinje ngengqele eqhelekileyo okanye isifo sesono
    • intloko ebuhlungu
    • isicaphucaphu
  • Inokwenzeka nge-Enbrel:
    • Ukuphendula kolusu kwindawo ejikeleze indawo yakho yenaliti
  • Inokwenzeka kunye ne-Orencia kunye ne-Enbrel:
    • akukho ziphumo ebezingalindelekanga eziqhelekileyo ekwabelwana ngazo

Iziphumo ebezingalindelekanga ezimandundu

Olu luhlu lunemizekelo yeziphumo ebezingalindelekanga ezinokubakho nge-Orencia, kunye ne-Enbrel, okanye zombini iziyobisi (xa zithathwa ngokwahlukeneyo).

  • Ngaba kunokwenzeka nge-Orencia:
    • akukho ziphumo bezingalindelekanga zinzulu ezizodwa
  • Inokwenzeka nge-Enbrel:
    • iingxaki kwiinkqubo zakho zemithambo-luvo (multiple sclerosis, ukuxhuzula, ukudumba kwemithambo-luvo)
    • amanqanaba asezantsi iiseli ezithile zegazi, ezinjengeeseli ezimhlophe zegazi kunye neeplatelets
    • iingxaki zentliziyo, ezinje ngokusilela kwentliziyo
    • iingxaki zesibindi, ezinje ngokusilela kwesibindi
    • usulelo olubi, njengesifo sephepha (TB) *
  • Inokwenzeka kunye ne-Orencia kunye ne-Enbrel:
    • umhlaza *
    • ukuphinda kusebenze intsholongwane ye-hepatitis B (ukuvutha kwentsholongwane ukuba sele ingaphakathi komzimba wakho)
    • izifo ezinzulu, ezifana ne-pneumonia
    • negazi lakho kakhulu

Ukusebenza ngempumelelo

Zombini i-Orencia kunye ne-Enbrel zivunyiwe yi-FDA ukunyanga isifo samathambo, i-psoriatic arthritis, kunye ne-juvenile idiopathic arthritis. Ukusebenza kwawo omabini la machiza ekunyangeni ezi meko kuthelekiswa apha ngezantsi.

Ukusebenza kakuhle kunyango lwe-rheumatoid arthritis

La machiza awakhange athelekiswe ngokuthe ngqo kwizilingo zeklinikhi. Kodwa izifundo ezahlukileyo zifumanise ukuba zombini i-Orencia kunye ne-Enbrel ziyasebenza ekunyangeni isifo samathambo (RA).

Ukusebenza ngokunyanga i-psoriatic arthritis

La machiza awakhange athelekiswe ngokuthe ngqo kwizilingo zeklinikhi. Kodwa izifundo ezahlukileyo zifumanise ukuba zombini i-Orencia kunye ne-Enbrel ziyasebenza ekunyangeni i-psoriatic arthritis (PsA).

Ukusebenza ngokunyanga i-juvenile idiopathic arthritis

Uphengululo lwezifundo lujonge ukuba uOrencia kunye no-Enbrel basebenza njani ukunyanga i-juvenile idiopathic arthritis (JIA) ebantwaneni. Ekupheleni koqwalaselo, iingcali ziyavuma ukuba omabini la machiza anokukhuseleka ngokukuko kunye nokusebenza ngokunyanga le meko.

Iindleko

I-Orencia ne-Enbrel zombini zineziyobisi ezinamagama. Okwangoku azikho iifom ze-biosimilar ze-Orencia ezikhoyo. Isilwanyana esine-biosimilar sinokuthelekiswa nesilwanyana esiqhelekileyo. Ichiza elenza lafana nelo lingumenzi ikopi yesiyobisi esiqhelekileyo (eso senziwe ngeekhemikhali). Iyeza elenziwa ngebhayosimili lenziwa lifane nesiyobisi se-biologic (esenziwe ngeeseli eziphilayo).

Iyeza le-biosimilar kwi-Enbrel liyafumaneka kwifom enikwa ngokufakwa ngaphakathi (IV). Iingcali zicebisa ukusebenzisa ii-biosimilars ukunyanga i-RA, i-PsA, kunye ne-JIA xa ikhuselekile kwaye isebenza kwimeko yakho. Thetha nogqirha wakho ukuze ufumane ukuba i-biosimilar ikulungele na.

Amayeza egama leBrand ahlala exabisa ngaphezulu kweendleko zeziyobisi ze-biosimilar

Ngokwengqikelelo yeGoodRx.com, i-Enbrel inokubiza ngaphezulu kweOrencia. Elona xabiso uzakuhlawula ngalo naliphi na ichiza liya kuxhomekeka kwisicwangciso sakho seinshurensi, indawo okuyo, kunye nekhemesti oyisebenzisayo.

I-Orencia kunye notywala

Akukho nxibelelwano lwaziwayo phakathi kwe-Orencia kunye notywala. Kodwa ukusela kakhulu utywala kunokwenza mandundu iimpawu zakho zamathambo kunye nokuqhubela phambili kwesi sifo. Kwakhona, utywala bunokudibana nezinye iziyobisi ozithathayo.

Thetha nogqirha wakho malunga nokuba ungakanani utywala obukhuselekileyo ukuba ungasela. Baza kuxoxa ngonyango lwakho lwamathambo kwaye bacebise ukuba ingaba utywala bukhuselekile ukuba ubutye.

Unxibelelwano lwe-Orencia

I-Orencia inokusebenzisana namanye amayeza. Inokuphinda inxibelelane nezinye izongezo kunye nokutya okuthile.

Unxibelelwano olwahlukileyo kunokubangela iziphumo ezahlukeneyo. Umzekelo, unxibelelwano oluthile lunokuphazamisa ukusebenza kakuhle kwesiyobisi. Olunye unxibelelwano lunokunyusa iziphumo ebezingalindelekanga okanye lubenze bube nzima ngakumbi.

Orencia kunye namanye amayeza

Apha ngezantsi kukho uluhlu lwamayeza anokusebenzisana ne-Orencia. Olu luhlu alunazo zonke iziyobisi ezinokusebenzisana ne-Orencia.

Ngaphambi kokuba uthathe i-Orencia, thetha nogqirha wakho kunye nosokhemesti. Baxelele ngawo onke amayeza kagqirha, ekhawuntareni, kunye nezinye iziyobisi ozithathayo. Baxelele malunga nazo naziphi na iivithamini, amayeza esintu kunye nezixhasi ozisebenzisayo. Ukwabelana ngolu lwazi kunokukunceda uphephe unxibelelwano olunokubakho.

Ukuba unemibuzo malunga nokunxibelelana kweziyobisi okunokuchaphazela, buza ugqirha wakho okanye usokhemesti.

Anti-TNFs

I-Anti-TNFs liqela leziyobisi ezisetyenziselwa ukunyanga isifo samathambo (RA), isifo samathambo (PsA), kunye nejuniile idiopathic arthritis (JIA). La machiza asebenza ngokudibanisa kunye nokuthintela isenzo seprotein ebizwa ngokuba yi-tumor necrosis factor (TNF).

Imizekelo yeziyobisi ezichasene ne-TNF zibandakanya:

  • adalimumab (Humira)
  • I-etanercept (i-Enbrel)
  • infliximab (I-Remicade)

Zombini i-Orencia kunye ne-anti-TNFs zinciphisa amandla omzimba wakho wokulwa nosulelo olutsha okanye olukhoyo.Ukuthatha la mayeza kunye kunokuwonyusa umngcipheko wokufumana usulelo olutsha kunye nokunciphisa ukubanakho kwakho ukulwa nezifo esele zingaphakathi emzimbeni wakho.

Thetha nogqirha wakho ukuba uthatha okanye uceba ukuqala ukuthatha ichiza elichasene ne-TNF ngelixa usebenzisa i-Orencia. Ugqirha wakho unokuxoxa ngezidingo zakho zonyango kwaye acebise amayeza akhuselekileyo ukuba uwathathe.

Amanye amayeza e-rheumatic

Zombini i-Orencia kunye namanye amayeza e-rheumatic, kubandakanya i-Xeljanz, achaphazela amajoni akho omzimba. La machiza anciphisa amandla omzimba wakho wokulwa izifo. Ukuthatha i-Orencia kunye nezinye iziyobisi ze-rheumatic kunokunciphisa amandla omzimba wakho omzimba kakhulu. Oku kunokunyusa umngcipheko wosulelo.

Tshela ugqirha wakho ukuba uthatha nawaphi na amanye amayeza e-rheumatic ngaphandle kwe-Orencia. Ugqirha wakho angayalela iimvavanyo zokujonga ukuba amajoni akho omzimba asebenza njani kwaye akucebise ngesona sicwangciso sonyango sisebenzayo.

I-Orencia kunye nemifuno kunye nezongezelelo

Akukho nanye imifuno okanye izongezo eziyaziwayo ukusebenzisana ne-Orencia. Nangona kunjalo, kuya kufuneka ujonge ugqirha wakho okanye usokhemesti ngaphambi kokusebenzisa naziphi na izongezo ngelixa uthatha i-Orencia.

Usebenza njani u-Orencia

I-Orencia ivunyiwe ukunyanga izifo ezithile ezizimele. Isebenza emzimbeni wakho ukunceda ukunciphisa iimpawu kunye nokucotha ukuqhubela phambili (ukuwohloka) kwezi zifo.

Ziziphi izifo ezizimele?

Amajoni akho omzimba akhusela umzimba wakho kwizifo. Ukwenza oku ngokuhlasela iintsholongwane kunye neentsholongwane ezingena ngaphakathi okanye esele zingaphakathi komzimba wakho.

Kodwa ngamanye amaxesha amajoni akho omzimba ayadideka, kwaye aqala ukuhlasela iiseli zakho. Ukuba ayiyeki, ibangela izifo ezenzekelayo. Ngezi zifo, amajoni akho omzimba ahlasela iiseli ezenza izicwili zomzimba wakho kunye namalungu.

I-rheumatoid arthritis (RA), i-psoriatic arthritis (i-PsA), kunye ne-juvenile idiopathic arthritis (JIA) zonke iimeko ezizimeleyo. Oku kuthetha ukuba ukuba unale miqathango, amajoni akho omzimba ahlasela owakho umzimba.

Wenza ntoni uOrencia?

I-Orencia isebenza ngokudibanisa iiproteni ezimbini (ezibizwa ngokuba yi-CD80 kunye neCD86) ezifumaneka kwiiseli ezithile zomzimba. I-CD80 kunye ne-CD86 yeeproteni zisebenzisa olunye uhlobo lweeseli zomzimba, ezibizwa ngokuba zii-T seli. Iiseli zakho ze-T ziluhlobo oluthile lweseli olunceda amajoni akho omzimba alwe nosulelo.

Ngokuncamathisela kwezi proteni, i-Orencia iyeka iiseli ze-T ekusebenzeni kakuhle. Oku kuthintela amajoni akho omzimba ekuhlaseleni iiseli zakho, izicwili kunye namalungu.

I-Orencia inceda ukucothisa ukuqhubela phambili (ukuwohloka) kwesifo samathambo, i-psoriatic arthritis, kunye ne-juvenile idiopathic arthritis. Iyeza linciphisa iimpawu zale meko, likwenza uzive ungcono.

Kuthatha ixesha elingakanani ukusebenza?

I-Orencia iya kuqala ukusebenza emzimbeni wakho nje ukuba uqale ukuyithatha. Kodwa i-rheumatoid arthritis, i-psoriatic arthritis, kunye ne-juvenile idiopathic arthritis ziimeko ezithatha ixesha ukunyanga. Kwizifundo zeklinikhi, abantu babenokuphucuka kwinqanaba labo leentlungu kunye nokusebenza ngokubanzi kwiinyanga ezintathu zokuqala unyango. Nangona kunjalo, impendulo yomntu ngamnye kwi-Orencia iya kuba yodwa.

I-Orencia yenzelwe ukuba ithathwe njengeyeza lexesha elide. Isebenza yonke imihla emzimbeni wakho ukugcina imeko yakho inyangwa. Ukuba uyeka ukuthatha ngokukhawuleza, iimpawu zakho zingabuya kwakhona.

Ungayeki ukuthatha i-Orencia emva kokuba iimpawu zakho zisombulule. Ukuba ufuna ukuyeka ukuthatha eli chiza, thetha nogqirha wakho. Baza kuvavanya imeko yakho kwaye babone ukuba usafuna ukuthatha i-Orencia.

I-Orencia kunye nokukhulelwa

Akukho zifundo zaneleyo ebantwini ukuba bazi ngokuqinisekileyo ukuba i-Orencia ikhuselekile ukuyisebenzisa ngexesha lokukhulelwa. Izifundo zezilwanyana zibonisa ukuba i-Orencia inokuchaphazela usana olusakhulayo ukuba lusetyenziswe ngexesha lokukhulelwa. Kodwa izifundo kwizilwanyana azihlali ziqikelela ukuba kwenzeka ntoni ebantwini.

Yazisa ugqirha wakho ukuba ukhulelwe okanye ukhulelwe ngelixa usebenzisa i-Orencia. Baza kuxoxa ngonyango lwakho kwaye bacebise ukuba ukusebenzisa i-Orencia kukhuselekile ukuba ukwenze ngexesha lokukhulelwa.

Irejista yokukhulelwa iyafumaneka kwabasetyhini abathathe okanye abathatha i-Orencia ngexesha lokukhulelwa. Ukuba ukhulelwe kwaye uthatha i-Orencia, ugqirha wakho unokucela ukuba ubhalise. Ubhaliso luvumela oogqirha ukuba baqokelele ulwazi malunga nokhuseleko lokusetyenziswa kwe-Orencia kubafazi abakhulelweyo. Ukufumana ulwazi oluthe kratya malunga nobhaliso, tsalela umnxeba ku-877-311-8972 okanye undwendwele iwebhusayithi yobhaliso.

I-Orencia kunye nolawulo lokuzalwa

Ayaziwa ukuba i-Orencia ikhuselekile ukuthatha ngexesha lokukhulelwa. Ukuba wena okanye iqabane lakho owabelana nalo ngesondo unokukhulelwa, thetha nogqirha wakho malunga neemfuno zakho zolawulo lokuzalwa ngelixa usebenzisa eli chiza.

I-Orencia kunye nokuncelisa

Akukho zifundo ebantwini eziye zajonga ukhuseleko lokusetyenziswa kwe-Orencia kwabasetyhini abancancisayo. Izifundo kwizilwanyana zibonise ukuba i-Orencia idlulela kubisi lwebele lwezilwanyana ezinikwe ichiza. Kodwa akwaziwa ukuba ichiza lichaphazela izilwanyana ezitya olo bisi lwebele.

Gcina ukhumbula ukuba izifundo kwizilwanyana azihlali ziqikelela ukuba kwenzeka ntoni ebantwini.

Tshela ugqirha wakho ukuba uncelisa okanye uceba ukuncelisa xa uthatha i-Orencia. Bayakucebisa ngeyona ndlela ikhuselekileyo yokondla umntwana wakho.

Iindleko ze-Orencia

Njengawo onke amayeza, iindleko ze-Orencia ziyahluka.

Ixabiso langempela oza kulihlawula lixhomekeke kwisicwangciso sakho seinshurensi, indawo okuyo, kunye nekhemesti oyisebenzisayo.

Uncedo lwezezimali kunye neinshurensi

Ukuba ufuna inkxaso yemali ukuhlawula i-Orencia, okanye ukuba ufuna uncedo lokuqonda i-inshurensi yakho, uncedo luyafumaneka.

I-Bristol-Myers Squibb, umenzi we-Orencia, unikezela ngenkqubo ye-copay kubantu abasebenzisa ifom ye-Orencia. Ngolwazi oluthe kratya kunye nokufumanisa ukuba uyilungele na inkxaso, tsalela umnxeba u-800-ORENCIA (800-673-6242) okanye undwendwele iwebhusayithi yenkqubo.

Ukuba ufumana i-Orencia nge-infravenous (IV) infusions, ungaqhagamshelana neqela leNkxaso yokuFikelela kweBristol-Myers Squibb ukuze ufunde malunga nokhetho lweendleko. Ukufumana ulwazi oluthe kratya, tsalela umnxeba ku-800-861-0048 okanye undwendwele iwebhusayithi.

Ungamthatha njani u-Orencia

Kuya kufuneka uthathe i-Orencia ngokwemiyalelo kagqirha wakho okanye yezempilo.

I-Orencia ngokufakwa ngaphakathi

Ngamanye amaxesha, ugqirha wakho unokucebisa ukuba ufumane i-Orencia nge-infravenous (IV) infusion (inaliti emthanjeni wakho onikwe ixesha elingaphezulu).

Kule meko, kuya kufuneka ucwangcise ixesha lokudibana kwiklinikhi yakho yezempilo. Nje ukuba useklinikhi ukufakelwa kwakho, abasebenzi bezonyango baya kukusa kwigumbi elifanelekileyo. Baza kufaka inaliti emthanjeni wakho kwaye banxibelelanise inaliti kwingxowa ezaliswe lulwelo oluqukethe i-Orencia.

Ukufakwa kwakho kuya kuthatha imizuzu engama-30. Ngeli xesha, ulwelo oluqukethe i-Orencia luya kususwa kwingxowa ye-IV, ngenaliti, kunye nasemthanjeni wakho.

Emva kokuba ufumene lonke ulwelo lwe-Orencia, inaliti iya kususwa emthanjeni wakho. Ugqirha wakho unokufuna ukukujonga okwethutyana ngaphambi kokuba uphume ekliniki. Oku kwenziwa ukuqinisekisa ukuba awunayo imiphumo emibi emva kokuba ufumene i-Orencia.

I-Orencia ithathwe ngenaliti engaphantsi

Ugqirha wakho unokucebisa ukuba ufumane i-Orencia ngenaliti engaphantsi (inaliti phantsi kolusu lwakho).

Ekuqaleni, umboneleli wakho wezempilo unokufuna ukukunika inaliti yakho ye-Orencia. Oku kuvumela ukuba bachaze inkqubo yenaliti kwaye bakubonise ngqo indlela yokwenza. Emva kokuba ugqirha wakho ekubonisile ukuba ungayenza njani inaliti ye-Orencia, banokukucela ukuba uqale uzinike inaliti yeyeza.

Inaliti nganye ye-Orencia inokwenziwa ngezixhobo ezimbini ezahlukeneyo: isirinji ekhethiweyo okanye i-autoJjector ekhethiweyo ye-ClickJect. Isixhobo ngasinye siza kuza nexabiso ngqo le-Orencia elimiselwe ngugqirha wakho. Awunakulinganisa idosi yakho ye-Orencia ngenaliti nganye. Ababoneleli bakho bezononophelo lwempilo baya kukunika imiyalelo yenyathelo nenyathelo ngendlela yokusebenzisa isixhobo osinikiweyo.

Buza ugqirha wakho ukuba awuqinisekanga malunga nendlela yokuzitofa ngayo i-Orencia. Baza kuhlaziya inkqubo kunye nawe. Ungandwendwela iwebhusayithi ye-Orencia ukuze ufunde okungakumbi malunga nokuzitofa ngokwakho.

Nini ukuthatha

Nje ukuba uqale ukuthatha i-Orencia okokuqala, uya kufumana ishedyuli yedosi. Kuya kufuneka uthathe u-Orencia ngokwale shedyuli.

Izikhumbuzo zamayeza zinokukunceda uqiniseke ukuba ulandela ishedyuli yakho yedosi.

Imibuzo eqhelekileyo malunga ne-Orencia

Nazi iimpendulo kwimibuzo ebuzwa rhoqo malunga ne-Orencia.

Ndingamthatha u-Orencia ukuba ndineCOPD?

Unokwazi. Ngamanye amaxesha i-Orencia icetyiswa ukuba isetyenziswe kubantu abaneentlobo ze-arthritis abanesifo esingapheliyo se-pulmonary disease (COPD). Kodwa aba bantu kufuneka bajongwe ngononophelo ngelixa besebenzisa iziyobisi.

Ukuba unayo i-COPD, ukuthatha i-Orencia kunokunyusa umngcipheko wokuba neziphumo ebezingalindelekanga ezithile. Ngapha koko, inokunyusa umngcipheko wokuba nobunzima ngokuphefumla. Ukuba unayo i-COPD kwaye usebenzisa eli chiza, ugqirha wakho unokukujonga ngokusondeleyo ukuqinisekisa ukuba i-Orencia ikhuselekile kuwe.

Tshela ugqirha wakho ukuba unayo i-COPD kwaye unengxaki yokuphefumla ngelixa uthatha i-Orencia. (Jonga icandelo "lokuLumkisa" elingezantsi ngolwazi oluthe kratya.) Ugqirha wakho angacebisa ukuba i-Orencia ikhuselekile ukuba ungayisebenzisa. Ukuba akukhuselekanga, baya kukunika amanye amayeza akhuselekileyo kuwe.

Ndingazifumana izitofu xa ndisebenzisa iOrencia?

Unokwazi ukufumana izitofu ezithile ngexesha lonyango lwe-Orencia. Nangona kunjalo, akufanele ufumane izitofu zokuphila xa uthatha i-Orencia, okanye iinyanga ezi-3 emva kwedosi yakho yokugqibela.

Amayeza okugonya aphilayo aqulathe uhlobo olubuthathaka lwentsholongwane okanye iintsholongwane. Ngelixa uthatha i-Orencia, amajoni akho omzimba akakwazi ukulwa nosulelo njengoko kuqhele ukwenzeka. Ukuba ufumana isitofu sokugonya esiphilayo ngelixa uthatha i-Orencia, unokufumana usulelo ekuthintelwe lona isitofu sokukhusela.

Ukuba ufumana isitofu sokugonya esingaphiliyo ngexesha lonyango lwe-Orencia, isenokungasebenzi kakuhle ukukukhusela kulosuleleko lwenzelwe oko. Kodwa usavunyelwe ukufumana ezi ntlobo zokugonya ngexesha lonyango.

Qinisekisa ukuba zonke izitofu zakho okanye zokugonya umntwana wakho zihlaziyiwe ngaphambi kokuqala unyango lwe-Orencia. Ukuba unemibuzo malunga nokuba zeziphi izitofu zokugonya ezifunekayo, thetha nogqirha wakho. Bayakucebisa ukuba ukugonywa kungamiswa.

Ukuba ndifumana usulelo ngelixa ndisebenzisa i-Orencia, ndingayithatha iyeza lokubulala iintsholongwane?

Ewe. Akukho kunxibelelana kwaziwayo phakathi kwe-Orencia kunye ne-antibiotics.

Ukuba ufumana usulelo olutsha ngelixa uthatha i-Orencia, buza ugqirha wakho ukuba ufuna ukuthatha isibulala-zintsholongwane. Banokumisela isibulala-zintsholongwane esisebenza kakuhle xa sithathwa ne-Orencia.

Ndingamsa u-Orencia ekhaya?

Kuxhomekeka kwindlela acebisa ngayo ugqirha ukuba uthathe i-Orencia.

Ugqirha wakho unokufuna ukuba uthathe i-Orencia nge-infravenous (IV) infusion. Oku kuthetha ukuba umboneleli wezempilo uya kubeka inaliti emthanjeni wakho, kwaye uya kufumana ichiza ngenaliti njenge-infusion. Kule meko, awunakuthatha i-Orencia ekhaya. Uya kudinga ukutyelela iklinikhi yokhathalelo lwempilo kunyango lwakho.

Ngaphandle koko, ugqirha wakho unokufuna ukuba uthathe i-Orencia ngenaliti engaphantsi. Kule meko, i-Orencia iya kutofelwa ngenaliti phantsi kolusu lwakho. Inaliti yokuqala kufuneka yenziwe kwiklinikhi yokhathalelo lwempilo ngabasebenzi bezonyango. Kodwa emva koku, uya kuba nakho ukuzitofa u-Orencia ekhaya.

Ndingayisebenzisa i-Orencia ukuba ndinesifo seswekile?

Ewe, kodwa kuya kufuneka ulumke ukuba uthatha i-Orencia nge-infravenous (IV) infusion. Kule meko, i-Orencia inikwa njengesitofu emthanjeni wakho.

Ifom ye-Orencia esetyenziselwa ukumiliselwa kwe-IV iqulethe i-maltose. Le nto ayisebenzi emzimbeni wakho ukunyanga imeko yakho, kodwa ichaphazela indlela ezinye izixhobo ezilinganisa ngayo amanqanaba eswekile yegazi. Xa ubonakaliswe kwi-maltose, ezinye iiglucose (iswekile yegazi) iimonitha zingabonisa ukuba unamazinga aphezulu eswekile yegazi kunokuba kunjalo.

Yazisa ugqirha wakho ukuba unesifo seswekile kwaye uthatha i-Orencia ngokusebenzisa i-IV infusions. Bayakucebisa ngeyona ndlela ilungileyo yokulinganisa amanqanaba eswekile yegazi ngexesha lonyango.

Ngaba i-Orencia inganceda ekulahlekeni kweenwele?

U-Orencia khange abonakalise ukuba uyasebenza ekumiseni ukulahleka kweenwele. Nangona olunye uphando lweklinikhi luvavanye ukusetyenziswa kwayo kokulahleka kweenwele, isifundo besisincinci kwaye sibandakanya kuphela abantu abali-15.

Thetha nogqirha wakho ukuba ukhathazekile malunga nokulahleka kweenwele. Baza kukucebisa malunga nendlela yokumelana nayo kwaye banokumisela amayeza okuyilawula.

Ndingahamba xa ndithatha iOrencia?

Ewe, unokuhamba, kodwa kuya kufuneka uqiniseke ukuba awuphosi nayiphi na idosi yakho ye-Orencia.

Ukuba ufumana i-Orencia kwiklinikhi yezempilo, thetha nomboneleli wakho wezempilo malunga nezicwangciso zakho zokuhamba. Baya kuqinisekisa ukuba ishedyuli yakho yethamo ayiphazamisi uhambo lwakho.

Ukuba ujova i-Orencia, qiniseka ukuba uyakwazi ukuthatha iyeza kunye nawe ukuba uya kuyidinga idosi yakho ngelixa ungekho ekhaya. Buza ugqirha wakho okanye usokhemesti malunga nendlela yokupakisha kunye nokugcina i-Orencia ngelixa useluhambeni.

Ndidinga isigunyaziso sangaphambili sokufumana i-Orencia?

Kuxhomekeke kwisicwangciso sakho seinshurensi. Izicwangciso ezininzi zeinshurensi zicela ugunyaziso lwaphambi kokuba ufumane i-inshurensi ye-Orencia.

Ukucela ugunyaziso lwangaphambili, ugqirha wakho uya kugcwalisa amaphepha kwinkampani yakho yeinshurensi. Inkampani yeinshurensi iya kuthi emva koko iphonononge eli phepha kwaye ikwazise ukuba isicwangciso sakho siya kugubungela i-Orencia.

Izilumkiso ze-Orencia

Ngaphambi kokuba uthathe i-Orencia, thetha nogqirha wakho malunga nembali yakho yezempilo. I-Orencia isenokungakulungeli ukuba uneemeko ezithile zonyango okanye ezinye izinto ezichaphazela impilo yakho. Oku kubandakanya:

  • Ukusetyenziswa kweziyobisi ezichasene ne-TNF. Ukuba uthatha iziyobisi ezichasene ne-TNF (ezibandakanya i-Humira, i-Enbrel, kunye ne-Remicade) kunye ne-Orencia, amandla amajoni akho omzimba wokulwa nezifo anokuncitshiswa kakhulu. Oku kwandisa umngcipheko wokuba yingozi, kwaye ngamanye amaxesha usongela ubomi, usulelo. Thetha nogqirha wakho malunga nawo onke amayeza owathathayo ngaphambi kokuqala i-Orencia.
  • Imbali yosulelo oluphindaphindiweyo okanye olufihlakeleyo. Ukuba unesifo esivela rhoqo (usulelo olubuya rhoqo), ukuthatha i-Orencia kunokunyusa umngcipheko wokuphindaphindeka rhoqo. Ukuba unalo naluphi na usulelo olufihlakeleyo (usulelo olungenazimpawu), ukuthatha i-Orencia kunokunyusa umngcipheko wokuba nesifo. Usulelo oluqhelekileyo oluqhelekileyo lubandakanya isifo sephepha (i-TB) kunye ne-hepatitis B virus. Thetha nogqirha wakho malunga nembali yosulelo ngaphambi kokuqala i-Orencia.
  • Isidingo sokugonywa. Ukuba ufumana ugonyo ngelixa uthatha i-Orencia, izitofu zisenokungasebenzi kakuhle emzimbeni wakho. Thetha nogqirha wakho malunga naziphi na izitofu onokuzidinga ngaphambi kokuba uqale ukuthatha i-Orencia.
  • Isifo esinganyangekiyo semiphunga (COPD). Ukuba unayo i-COPD, ukuthatha i-Orencia kunokuzenza mandundu iimpawu zakho zeCOPD. Ngenxa yoku, unokufuna ukubek'esweni ngokusondeleyo ukuba uthatha eli chiza. Ukuba unembali ye-COPD, thetha nogqirha wakho ngaphambi kokuba uqale ukuthatha i-Orencia.
  • Impendulo ebukhali e-Orencia. Akufanele uthathe i-Orencia ukuba uye waba neempendulo ezinzima kwiyeza elidlulileyo. Ukuba awuqinisekanga nokuba ngaba une-allergical reaction, thetha nogqirha wakho ngaphambi kokuba uqalise i-Orencia.
  • Ukukhulelwa. Ukusetyenziswa kwe-Orencia ngexesha lokukhulelwa akuzange kufundwe ebantwini. Thetha nogqirha wakho malunga nokuba i-Orencia ikhuselekile ukuyisebenzisa ngexesha lokukhulelwa. Ngolwazi oluthe kratya, jonga icandelo le- "Orencia kunye nokukhulelwa" apha ngasentla.
  • Ukuncancisa. Ayaziwa ngokuqinisekileyo ukuba i-Orencia ikhuselekile ukuthatha ngelixa uncancisa. Ngolwazi oluthe kratya, nceda ubone icandelo le- "Orencia kunye nokuncancisa" apha ngasentla.

Phawula: Ngolwazi oluthe kratya malunga neempembelelo ezinokubakho ze-Orencia, jonga icandelo le- "Orencia icala" elingentla.

Orencia libanda

Sebenzisa ngaphezulu komthamo ocetyiswayo we-Orencia kunokukhokelela kwiziphumo ebezingalindelekanga ezibi. Ngolwazi oluthe kratya malunga neziphumo ebezingalindelekanga ezimandundu, nceda ubone icandelo "leziphumo ebezingalindelekanga ze-Orencia" apha ngasentla.

Kufuneka wenze ntoni xa uthe wagqithisa?

Ukuba ucinga ukuba uthathe kakhulu eli chiza, tsalela ugqirha wakho. Ungabiza uMbutho waseMelika wamaZiko oLawulo lweTyhefu ku-800-222-1222 okanye usebenzise isixhobo esikwi-Intanethi. Kodwa ukuba iimpawu zakho zinzima, tsalela umnxeba ku-911 okanye uye kwigumbi likaxakeka elikufutshane ngoko nangoko.

Ukuphelelwa lixesha kwe-Orencia, ukugcinwa kunye nokulahlwa

Xa ufumana i-Orencia kwikhemesti, usokhemesti uya kongeza umhla wokuphelelwa kwileyibhile esebhotileni. Lo mhla uqhele ukuba ngunyaka omnye ukusukela kumhla wokuhambisa kwabo amayeza.

Umhla wokuphelelwa unceda ekuqinisekiseni ukusebenza kwamayeza ngeli xesha. Isimo sangoku soLawulo lwezoKutya kunye noLawulo lweziyobisi (i-FDA) kukuphepha ukusebenzisa amayeza aphelelwe lixesha. Ukuba awusebenzisanga iyeza elidlulileyo kumhla wokuphelelwa kwalo, thetha nosokhemesti wakho malunga nokuba unganako na ukuyisebenzisa.

Ukugcina

Ukuhlala ixesha elingakanani iyeza lihlala lilungile kunokuxhomekeka kwizinto ezininzi, kubandakanya ukuba uligcina phi kwaye phi na iyeza.

I-Orencia kufuneka igcinwe kwifriji kubushushu obungu-36 ° F ukuya kuma-46 ° F (2 ° C ukuya ku-8 ° C). Kuya kufuneka ugcine amayeza ekhuselekile ekukhanyeni kwaye agcinwe ngaphakathi kwipakethe yokuqala. Akufanele uvumele i-Orencia (ngaphakathi nokuba iisirinji ezizalisiweyo okanye ii-autoinjectors ze-ClickJect) zibandiswe.

Ukulahla

Ukuba akusafuneki uthathe i-Orencia kwaye unamayeza aseleyo, kubalulekile ukuba uyilahle ngokukhuselekileyo. Oku kunceda ukuthintela abanye, kubandakanya abantwana kunye nezilwanyana zasekhaya, ekubeni bathathe iyeza ngengozi. Kuyanceda ukugcina ichiza lingonzakalisi okusingqongileyo.

Iwebhusayithi ye-FDA ibonelela ngeengcebiso ezininzi eziluncedo ngokulahla amayeza. Unokucela ikhemesti yakho ukuba ikwazi ukuba ulahla njani na amayeza akho.

Ulwazi lobungcali lweOrencia

Olu lwazi lulandelayo lubonelelwe ngoochwephesha kunye nabanye abaqeqeshi bezempilo.

Iimpawu

I-Orencia sisiyobisi se-biologic esiboniswe kunyango lwe:

  • iyasebenza, imodareyitha ukuya kubunzima be-rheumatoid arthritis (RA) kubantu abadala
  • i-psoriatic arthritis (PsA) esebenzayo kubantu abadala
  • iyasebenza, imodareyitha ukuya kubunzima beplartarticular juvenile idiopathic arthritis (JIA) kubantwana abaneminyaka emi-2 nangaphezulu

Unyango lwe-RA, i-Orencia inokusetyenziswa yodwa, okanye njenge-polytherapy xa idityaniswe neziyobisi eziguqula iziyobisi (i-DMARDs). Unyango lwe-JIA, i-Orencia inokusetyenziswa yodwa okanye ngokudibeneyo ne-methotrexate.

Nokuba imeko ithini na, i-Orencia akufuneki ukuba ilawulwe ngokubambisana kunye neyeza lokulwa ne-TNF.

Indlela yokusebenza

I-Orencia ibophelela kwiiseli-zeeproteni ze-CD80 kunye ne-CD86, ezifumaneka kwi-membrane yeseli yeeseli ezibonisa i-antigen. Oku kubopha kuthintela ukukhuthazwa kweprotein ye-CD28. I-CD28 ibalulekile ukwenza ii-T-lymphocyte zisebenze. Ukwenza kusebenze ii-T-lymphocyte kudlala indima ebalulekileyo kwi-pathogenesis ye-RA kunye ne-PsA.Ukuthintela oku kusebenze kunciphisa ukuqhubela phambili kwezi zifo.

Izifundo ze-in-vitro zibonisa ukuba ukubophelela kwi-CD80 kunye ne-CD86 kuneziphumo ezongezelelweyo zeselfowuni. Ngokujolisa kwi-T-lymphocyte, i-Orencia inciphisa ukwanda kwabo. Ikwathintela ukuveliswa kwee-cytokines eziphambili ezibalulekileyo ekuphenduleni komzimba. Ezi cytokines zibandakanya i-TNF-alpha, INF-gamma, kunye ne-IL-2.

Kwakhona, iimodeli zezilwanyana zibonise iziphumo ezongezelelweyo eziqwalaselweyo emva kolawulo lwe-Orencia. Izifundo ziveze ukuba i-Orencia inokucinezela ukudumba kunye nokunciphisa imveliso yamajoni omzimba ngokuchasene ne-collagen. Inokunciphisa umda kwimveliso yeeantigen ejolise kwi-INF-gamma. Nokuba ezi ntshukumo zibalulekile ekusebenzeni kweklinikhi kwe-Orencia kuhlala kungaziwa.

I-Pharmacokinetics kunye ne-metabolism

I-pharmacokinetics kunye ne-metabolism ye-Orencia ziyahluka ngokuxhomekeke kwimeko yokunyangwa. Ziyahluka ngokuxhomekeke kwindlela yolawulo.

Izifundo kubo bonke abantu abaguli zibonisa imeko yokususwa gwenxa kweziyobisi kunye nobunzima bomzimba. Nangona kunjalo, akukho mahluko ubalulekileyo kugqatso uxelwa kusetyenziso kubantu bobudala obahlukeneyo okanye isini. Kwizifundo, ukusetyenziswa kwe-methotrexate, anti-TNFs, NSAIDs, okanye corticosteroids khange kubangele umahluko omkhulu ekucaciseni.

RA: Ulawulo olungena ngaphakathi

Iidosi ezininzi ze-10 mg / kg kwizigulana ezine-rheumatoid arthritis (RA) zikhokelele kuxinzelelo lwe-295 mcg / mL. Ubomi besiqingatha sobomi bujongwa ngemini ye-13.1, kugqitywe i-0.22 ml / h / kg.

Kwizigulana ezine-RA, i-Orencia inyuke ngokulinganayo phakathi komthamo kunye noxinzelelo oluphezulu. Ubudlelwane phakathi komthamo kunye nendawo ephantsi kwegophe (AUC) ilandela imeko efanayo. Umthamo wosasazo ufikelela kwi-0.07 L / kg.

Ukulandela iidosi ezininzi ze-10 mg / kg, imeko ezinzileyo iyajongwa kumhla wama-60. Ukuxinana komkhombe okuzinzileyo kufikelelwe kuwo yi-24 mcg / mL.

Ulawulo lwenyanga lwe-Orencia alubangeli ukuqokeleleka kwenkqubo yamayeza.

RA: Ulawulo olungaphantsi

Xa ilawulwa ngendlela engaphantsi, i-Orencia ifikelela kubuncinci kunye noxinzelelo oluphezulu lwe-32.5 mcg / mL kunye ne-48.1 mcg / mL, ngokwahlukeneyo, ngemini yama-85. 2.

Ukucocwa kwenkqubo kufikelela kwi-0.28 mL / h / kg, ngomthamo wokuhanjiswa kwe-0.11 L / kg. I-subcutaneous bioavailability yi-78.6%, kunye nesiqingatha sobomi beentsuku eziyi-14.3.

I-PsA: Ulawulo olungenelelayo

I-Orencia ibonisa i-pharmacokinetics emiselweyo kumthamo ophakathi kwe-3 mg / kg kunye ne-10 mg / kg. Xa ilawulwa nge-10 mg / kg, i-Orencia ifikelela kugxininiso lwaseburhulumenteni ngokuzinzileyo ngosuku lwe-57. Ukuxinana komkhombe wejometri yi-24.3 mcg / mL ngosuku lwe-169.

I-PsA: Ulawulo olungaphantsi

Ukulawulwa kweeveki ezingaphantsi kwe-Orencia 125 mg kukhokelela kumjelo wejometri yomkhombe we-25.6 mcg / mL ngosuku lwe-169. Isimo esizinzileyo sifikelelwa ngomhla wama-57.

I-JIA: Ulawulo olungenelelayo

Kubantwana abaneminyaka emi-6 ukuya kweli-17 ubudala, i-Orencia ifikelela kubuncinci kunye neencopho zoxinzelelo lwe-11.9 mcg / mL kunye ne-217 mcg / mL, ngokwahlukeneyo, kwimeko ezinzileyo. Intsingiselo yokucacisa yi-0.4 mL / h / kg.

Izifundo ze-Pharmacokinetics zabantwana abangaphantsi kweminyaka emi-6 yobudala azifumaneki njengoko i-Orencia nge-infravenous infusion ingavunyelwanga ukuba isetyenziswe kolu luntu.

I-JIA: Ulawulo olungaphantsi

Kubantwana abaneminyaka emi-2 ukuya kweli-17, ulawulo lwe-Orencia lweveki nganye lufikelela kwimeko yozinzo ngosuku lwama-85.

Kuthetha ukugxila kwe-Orencia kuyahluka ngokusekwe kumthamo. Ngomhla we-113, i-Orencia ifikelela kugxininiso lwe-44.4 mcg / mL, 46.6 mcg / mL, kunye ne-38.5 mcg / mL kwiidosi ze-50 mg, 87.5 mg, kunye ne-125 mg ngokwahlukeneyo.

Ukungqinelana

Akukho zingqinisiso malunga nokusetyenziswa kwe-Orencia. Nangona kunjalo, ezinye izilumkiso kufuneka zithathwe ngaphambi nangexesha lolawulo lwazo. Ngolwazi oluthe kratya, jonga icandelo le- "Orencia precautions" apha ngasentla.

Ukugcina

Xa unikezwe njengebhotile ene-lyophilized powder, i-Orencia kufuneka ifakwe kwifriji kubushushu be-36 ° F ukuya kwi-46 ° F (2 ° C ukuya kwi-8 ° C). Ibhotile kufuneka igcinwe ngaphakathi kwephakheji yayo yoqobo kwaye ikhuselwe ekukhanyeni ukunqanda ukuthotywa.

Iisirinji ezizalisiweyo okanye ii-autoJjectors ze-ClickJect ze-Orencia kufuneka zikhenkceziswe kwiqondo lobushushu lama-36 ° F ukuya kuma-46 ° F (2 ° C ukuya ku-8 ° C). Amaqondo obushushu kufuneka alawulwe ukuthintela ukuqina kwesisombululo. Ezi zixhobo kufuneka zigcinwe ngaphakathi kwipakethe yazo yoqobo kwaye zikhuselwe ekukhanyeni ukunqanda ukuthotywa.

Iphepha elichazayo ukuba awusenanto oyifunayo: Iindaba zezoNyango namhlanje zenze zonke iinzame zokuqinisekisa ukuba zonke iinkcukacha zichanekile, zibanzi kwaye zihlaziyiwe. Nangona kunjalo, eli nqaku akufuneki lisetyenziswe endaweni yolwazi kunye nobuchule bengcali yezempilo enelayisensi. Kuya kufuneka usoloko uqhagamshelana nogqirha wakho okanye nolunye uqeqesho kwezonyango ngaphambi kokuba uthathe nawaphi na amayeza. Ulwazi lweziyobisi oluqulethwe apha luyakwazi ukutshintsha kwaye alujoliswanga ekusetyenzisweni konke okunokwenzeka, imikhombandlela, izilumkiso, izilumkiso, ukuhlangana kweziyobisi, ukungahambelani komzimba, okanye iziphumo ezibi. Ukungabikho kwezilumkiso okanye olunye ulwazi ngesiyobisi esinikiweyo akubonisi ukuba indibaniselwano yeziyobisi ikhuselekile, iyasebenza, okanye ifanelekile kuzo zonke izigulana okanye konke ukusetyenziswa okuthile.

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