Kwakwakuvunyelwene ne-Psoriatic Arthritis, i-Ankylosing Spondylitis, kunye neNgaphezulu
Sibanzi
I-Inflectra (infliximab-dyyb), i-biosimilar kwi- Remicade (infliximab), yamkelwe yi-US Food and Drug Administration (FDA) ngo-Ephreli 5, 2016. Ngokutsho kwe-FDA, "Imveliso ye-biosimilar iyimveliso yezinto eziphilayo ezivunyiwe ekuboniseni ukuba iyafana kakhulu nemveliso ye-biological yemvume ye-FDA, eyaziwa njengemveliso yereferensi, kwaye ayinalo ulwahlulo olusisiseko kwintlalo ngokubhekiselele kwokhuseleko kunye nokusebenza kwimveliso yenkcazelo.
Ukwahlukana okuncinci kuphela kwizinto ezingasebenzi ezingekho emzimbeni zivumelekile kwimveliso ye-biosimilar. "Khumbulula, i- blocker ye-TNF eyenziwe nguJanssen Biotech, Inc., yinkampani yokubhekisela kwi-Inflectra.
I-Inflectra yenziwe yi-Celltrion, Inc (e-Yeonsu-gu, Incheon, iRiphabhliki yaseKorea) ngo-Hospira weLake Forest, e-Illinois. I-Inflectra yi-biosimilar yesibili evunywe e-United States yi-FDA. Iyokuqala, iZarxio, yavunywa ngo-Matshi 6, 2015 malunga nezibonakaliso ezithile ezinxulumene nomhlaza.
Iinkcazo
I-Inflectra ivunyiwe kwaye inokumiselwa:
- izigulane ezineemodareyithyid arthritis .
- izigulane ezine- spondylitis ezingasebenzi .
- izigulane ezine- arthritis esebenzayo.
- izigulane zabantu abadala abaneengxaki ezingapheliyo ze-plaque psoriasis.
- izigulane zabantu abadala okanye abantwana abaneminyaka engama-6 ubudala kunye nangaphezulu ngokuthe ngqo kwi- Crohn isifo esichukumisayo esineempendulo ezinganeleyo kunyango oluqhelekileyo.
- abantu abadala ngokumelana ne-accerative colitis enesifo esichukumisayo esasineempendulo ezinganeleyo kwiyeza eziqhelekileyo.
Kwi-arthritis ye-rheumatoid, i-Inflectra isetyenziselwa ukunciphisa iimpawu kunye neempawu ezihambelana nesi sifo, zivimbela ukuqhubela phambili komonakalo odibeneyo kunye nokuphucula umsebenzi womzimba. Kwizigulane ezine-spondylitis e-ankylosing, i-Inflectra iboniswe ukunciphisa impawu kunye neempawu.
Kwi-psoriatic arthritis, i-Inflectra inokumiselwa ukunciphisa iimpawu kunye neempawu zesifo se-arthritis esisebenzayo, ukuvimbela ukuqhubela phambili komonakalo wesakhiwo kunye nokuphucula umsebenzi womzimba.
Isistim nokuLawula
Kwi-arthritis ye-rheumatoid, i-Inflectra ilawulwa njenge-infusion ye-intravenous (inikwe ngaphezu kweeyure eziyi-2) kwi-dose ye-3mg / kg enikezwe kwi-0, 2 kunye neeveki ezi-6. Emva koko, umthamo wesondlo we-3 mg / kg ulawulwa rhoqo kwiiveki ezi-8. Izigulane eziphathwe nge-Inflectra ye-rheumatoid arthritis kufuneka zithathe i- methotrexate . Izigulane ezineempendulo ezinganeleyo kumlinganiselo okhankanywe ngasentla zinokuthi idosi ihlelwe kwi-10mg / kg okanye ixesha eliphakathi kwamanani lingancishiswa rhoqo kwiiveki ezi-4. Ukuhlengahlengiswa kunokunyusa umngcipheko weempendulo ezimbi.
Ngokwe-spondylitis engavumelaniyo, i-dose ephakanyisiweyo ngu-5mg / kg njenge-infusion engena-intravenous kwi-0, 2, nakwiiveki ezi-6 zilandelwa ngumthamo wesondlo we-5 mg / kg nganye kwiiveki ezi-6. I-dose ephakanyisiweyo iphinde ibe ngu-5 mg / kg kwi-0, 2, kunye neeveki ezingama-6 ze-arthritis ye-psoriatic, kodwa i-dose yesondlo ye-5 mg / kg inikwe iiveki ezi-8. I-psoriatic arthritis, inokusetyenziswa kunye okanye ngaphandle kwe-methotrexate.
Izimpembelelo eziqhelekileyo
Impendulo eyingozi kakhulu, esekelwe kwizilingo zeekliniki zemveliso ye-infliximab, zibandakanya izifo (ukuphefumula okuphezulu, i-sinusitis, kunye ne-pharyngitis), ukuphendula okuxhatshazwayo (ukuphefumula okufutshane, ukuxubha, ukugqithisa), intloko yesisu kunye nesisu esiswini.
Ukungqinelana
I-Inflectra, kumayeza angaphezu kwama-5 mg / kg, akufanele ihanjiswe kwizigulane ezinokulinganisela ukuhluleka kwentliziyo. Kwakhona, i-Inflectra ayifanele ihanjiswe kwizigulane eziye zenza i-hypersensitivity reaction to Remicade (infliximab). I-Inflectra ayifanele ukuba ilawulwe kumntu nabanikezelayo nge-hypersensitivity eyaziwayo kuzo nayiphi na izithako ezingasebenziyo kwiziyobisi okanye kumaproteni.
Izilumkiso
Ezinye izilumkiso kunye nezilumkiso ziye zaqulunqwa ukuqinisekisa ukusetyenziswa okukhuselekileyo kwe-Inflectra. Ezi zi lumkiso ziquka:
- Ingozi yokuphuhlisa izifo ezinzulu - i-Inflectra akufanele ilawulwe ngexesha lokusuleleka. Kwakhona, ukuba usulelo luyaqhubeka ngelixa usebenzisa i-Inflectra, kufuneka lijongwe ngenyameko kwaye ukuba luba lukhulu kangakanani, i-Inflectra kufuneka imiswe. Izifo ezithintekayo (iintsholongwane ezenzeka ngokugqithiseleyo okanye ngokuphindaphindiweyo kulabo abanamasosha omzimba obuthathaka) ziye zaxelwa kwizigulane eziphathwe nge-block blockers. Kwakhona, ukusetyenziswa kwakhona kwesifo sofuba okanye isifo esitsha sesifo sofuba senzeke kunye nokusetyenziswa kwemveliso ye-infliximab.
- Izifo ezifayo ezifayo - Ukuba isigulane sikhula kwisifo se-systemic ngelixa isebenzisa i-Inflectra, unyango oluchasayo lufanele lucatshangelwe kulabo abahlala kwimimandla apho izimo zengqungquthela zihlala khona.
- Izibhambathiso - Isiganeko sezonyango, kuquka i-lymphoma, sifumaneke sikhulu kwizigulane eziphathwe nge-TNF blockers kunezolawulo. Umngcipheko / inzuzo yokusebenzisa i-Inflectra kufuneka ihlolwe, ngakumbi kwizigulane ezinezinto ezithile kwimbali yazo.
- I-virus ye-Hepatitis B (i-HBV) yokuqalisa kwakhona - Izigulane kufuneka zihlolwe kwi-virus ye-Hepatitis B ngaphambi kokuqala i-Inflectra. Abathwali be-HBV kufuneka bajongwe ngexesha kunye neenyanga eziliqela emva kokusebenzisa i-Inflectra. Ukuba ukuvuselelwa kwe-HBV kwenzeka, i-Inflectra kufuneka ishiywe kwaye unyango olususwe nentsholongwane.
- I-hepatotoxicity - Iingxaki ezinzima zokuziphendulela ziyakwenzeka. Abanye bangabulala okanye bafune ukufakelwa kwesibindi. Ngokuphuhliswa kwe-jaundice okanye i- enzyme yesibindi ephakamileyo, i-Inflectra kufuneka imiswe.
- Ukungaphumeleli kwentliziyo - Ukungaphumeleli kwintliziyo entsha okanye ukuphazamiseka kweempawu zesifo senhliziyo esele senzeke ngokusetyenziswa kwe-Inflectra.
- I-Cytopenias - Kukho ukunciphisa inani lamaseli egazi kunye nokusetyenziswa kwe-Inflectra. Izigulane kufuneka zifune unyango xa iimpawu zikhula.
- Ukunyuka kwe-Hypersensitivity - Ukuphendula ngokunyuka kwamanzi kungakhula, kubandakanywa ne-anaphylaxis okanye isifo sengqondo.
- Ukuhlaziya izifo - Ukuqala okutsha okanye ukuqhuma kwesifo se-demyelinating esele sikhona ngokusetyenziswa kwe-Inflectra.
- I-Lupus-like syndrome - I-syndrome ehambelana neempawu ezinjenge- lupus ingaphuhlisa ngokusetyenziswa kwe-Inflectra. Isiza kufuneka simiswe ukuba i-syndrome iyaqhubeka.
- Iigciwane eziphilayo okanye amayeza achaphazelekayo-akufanele anikezwe nge-Inflectra. Abantwana bamele bafikelele ngokusemthethweni kuzo zonke izitofu ngaphambi kokuqala i-Inflectra. Ukuba intsana ibonakaliswe kwi-utero ukuya kwi-Inflectra okanye i-infliximab, kufuneka kube ncinane ubuncinane beenyanga ezili-6 zokulinda emva kokuzalwa ngaphambi kokuba nayiphi na isitofu sokuphila.
I-Inflectra ithatha isilumkiso sebhokisi ebomnyama ngokubhekiselele kwengozi yokwanda kokusuleleka kwintsholongwane kunye ne-lymphoma, kunye nomyalelo wokuvavanya isifo sesifo sofuba ngaphambi kokuqala isilwanyana.
Ukusebenzisana kweziyobisi
Ukuhlanganiswa kwe-Inflectra ne-anakinra okanye i- Orencia (abatacept) ayikhuthazwa. Ukusetyenziswa kwe- Actemra (tocilizumab) kunye ne-Inflectra kufuneka kugwenywe ngenxa yokukwazi ukunyuswa kwe-immunosuppression kunye nokwanda komngcipheko wosulelo. I-Inflectra ayifanele idibaniswe nezinye iziyobisi ze-biologic .
Ngaphantsi
I-Biosimilars iye yaphuhliswa kwiminyaka ye-rheumatoid arthritis. Ukuba ne-biosimilar yokuqala ekugqibeleni i-FDA-yamkelwe into enkulu. Ukusuka kwimbono yesigulane, i-biosimilars inikezela ukhetho oluninzi lweyonyango (into enhle!) Kwaye ixabiso kufuneka lilingane nelona liphantsi kwezilwanyana ze-biologic zangaphambili (enye into enhle!). Sekunjalo, akuyi kufika ngaphandle kwengxabano. Kukho iinkxalabo ezichazwe ngabanye abantu malunga nokuba i-biosimilars iya kuba yilingani ngokwenene. Cinga i-generic counterus brand name medication oral - ingabe isebenza ngokulinganayo? Okuye kwaxutyushwa iminyaka emininzi. I-FDA ithi "izigulane kunye nabaqeqeshi bezempilo baya kukwazi ukuxhomekeka ekukhuselekeni nasekusebenzeni kwezinto eziphilayo kunye nemveliso eguquguqukayo, njengokuba bebeya kuba ngumqondiso wenkcazelo." Enyanisweni, izidakamizwa ze-biosimlar zivunyiwe ngokusekelwe kububungqina "bufana kakhulu" kwisichengululo seziyobisi. Ngaba iyafana ngokufanayo?
Kukho esinye isigaba, apho i-FDA idlala isicatshulwa esitshintshanayo. Ngokutsho kwe-FDA, "Imveliso ye-biological engaguquguqukiyo iyimveliso ye-FDA-evumelekileyo yemveliso kwaye ihlangabezana nemigangatho eyongezelelweyo yokutshintshana. Umkhiqizo we-biological ungatshintshwa kwimveliso yenkcazo yi-pharmist ngaphandle kokungenelela komboneleli wezempilo owamisela umqondiso wenkcazelo. "
Mhlawumbi kudideka kweli nqanaba. Njengamaxesha onke, isiluleko sethu kukuxoxisana nezidakamizwa kunye nodokotela wakho okanye u-rheumatologist. Kwakhona kubalulekile ukuba ufunde ngokuphendula kwimiba ye-rheumatology malunga nokuvunyelwa kwe-Inflectra kunye ne-biosimiliars ezayo. Funda le nkcazo kuJoan Von Feldt, MD, MSEd, uMongameli we-American College of Rheumatology.
> Imithombo:
Ulwazi lweNgcaciso yokuThengisa. 04/2016.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf
I-FDA ivuma i-Inflectra, i-Biosimilar ukuyibuyisela. 04/05/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
Ulwazi ngoBosimimilars. FDA. Ukuhlaziywa nge- 2/22/2016.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/
I-FDA iyavuma iMveliso ye-Biosimilar yokuqala yeZarxio. FDA. 03/06/2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm