I-JAK yokuqala Inhibitor ye-Rheumatoid Arthritis evunywe yi-FDA
I-Xeljanz (tofacitinib citrate), i- DMARD yomlomo ( isicatshulwa -anti-rheumatic drug), yavunywa yi-US Food and Drug Administration (FDA) ngoNovemba 6, 2012. Le nkunkuma ijoliswe kunyango yabantu abadala isifo se-rheumatoid esisisigxina esiye sineempendulo ezinganeleyo, okanye ukunganyamezelani, ukuya kwi- methotrexate . Yenziwe nge-Pfizer, i-Xeljanz iyisikrini esisijikelezileyo, esimhlophe, esikhatywe ngokukhawuleza ngefilimu kunye ne "Pfizer" kwelinye icala, kwaye "JKI5" ibhalwe ngaphesheya.
I-Xeljanz yi-DMARD yomlomo wokuqala evunyelwe isifo se-rheumatoid kwisifo se-arthritis kwiminyaka eyi-10. Kwakhona ngowokuqala kwiklasi elitsha lamachiza eyaziwa njengeJAK (Janus kinase) inhibitors. I-Xeljanz ingasetyenziswa njenge-monotherapy (yedwa), okanye idibene ne-methotrexate okanye enye i-DMARD engekho ye-biologic. I-Xeljanz ayifanele isetyenziswe ngeziyobisi ze-biologic okanye i-immunosuppressants, ezinjenge-Imuran (azathioprine) okanye i- cyclosporine .
Ingaba isebenza kanjani
Ngokwenene, iXeljanz isebenza ngokuthintela indlela yeJAK - indlela yokubonisa ngaphakathi kwiseli edlala indima ebalulekileyo ekuvukeleni ehambelana ne-rheumatoid arthritis. IiJAK ziyi-enzyme ezingenayo i-intracellular ezithumela izibonakaliso ezivela kwi- cytokine okanye ukukhula kwe-factor-receptor kwi-membrane yeseli.
I-Xeljanz ithathwa njengamayeza amancinci amachiza, kungekhona iyeza eziphilayo. I-Biologics, njenge- Enbrel (etanercept), i- Remicade (infliximab), i- Humira (adalimumab), i- Cimzia (certolizumab pegol), i- Simponi (golimumab), i- Orencia (i-abatacept), i- Actemra (i -cilizumab) kunye ne- Rituxan (rituximab) i-cytokines ene-block-inflammatory ngaphandle kweseli.
Uvavanyo lwezonyango
Izigulane ezingaphezu kwama-5,000 ze-rheumatoid arthritis zibandakanyeke kwizilingo ze-Xeljanz, zivelisa enye yezona nkcukacha ezinkulu kwiikliniki zonyango zonke izidakamizwa ze-rheumatoid arthritis ezithunyelwe kwi-FDA ukuze zihlaziywe, ngokutsho kwePfizer.
Kwakukho izilingo ezimbini zeeklinikhi ezavavanya udidi lwe-Xeljanz, kunye neesilingo ezingama-5 ezivandlakisayo ezivandlakisayo impendulo ye- ACR 20 kwi-Xeljanz, kunye ne- DAS28 kunye neMiphumo yemibuzo yokuHlola iMpilo.
Uvavanyo lwezonyango lubonise ukuba i-Xeljanz yanciphise kakhulu impawu kunye neempawu zesifo se-rheumatoid kunye nokusebenza ngokomzimba (ukukwazi ukwenza imisebenzi yemihla ngemihla).
Isistim
I-Xeljanz ithathwa ngomlomo, i-pilgrimu ye-5 mg ithathe kabini imihla ngemihla. Ingathathwa kunye okanye ngaphandle kokutya. I-11 mg ye-dose yemihla ngemihla iphinda ifumaneke njenge-Xeljanz-XR (ukukhululwa okwandisiweyo).
Iziphumo eziPhakathi
Iimpembelelo eziqhelekileyo ezichaphazelekayo ezihambelana neXeljanz, ezenzeke ngexesha leenyanga ezi-3 zokuqala ezisetyenzisweni kwizilingo zonyango, zaziyizifo eziphezulu zokuphefumula, intloko, isifo sohudo kunye ne-nasopharyngitis.
Izilumkiso kunye nokuqapha
I-Xeljanz ithatha isilumkiso esinobhokisi : izifo ezinzulu ezibangela ukulaliswa esibhedlele okanye ukufa, kubandakanya isifo sofuba kunye ne-bacterial, i-fungus engenayo, i-virus kunye nezinye izifo ezichaphazelekayo, zenzeke kwizigulane ezifumana iXeljanz; ukuba usulelo olunzulu lukhula, i-Xeljanz kufuneka ivalwe de kube isulelo lulawulwe; Ukuhlolwa kwephepha lesifo sofuba kufuneka kunikwe ngaphambi kokuqala iXeljanz; Izigulane ezithatha i-Xeljanz zimele zihlolwe ngenxa yesifo sofuba nangona uvavanyo lokuqala lubi; i-lymphoma kunye nezinye izigulane ziye zaphawula kwizigulane ezithatha iXeljanz; "I-Epstein Barr-inxulumene ne-lymphoproliferative disorder" ibonakaliswe kwizigulana zokutshintshiselwa kweengonyama eziphathwe ngeXeljanz zidibene nezidakamizwa zokuzibulala.
Ezinye izilumkiso: sebenzisa i-Xeljanz ngokulumkisa kwizigulane ezisengozini yokuxhamla isisu; I-Xeljanz ayilunyanzelwanga kwizigulane ezinezifo ezinobindi; Kunokucetyiswa iimvavanyo zebhoratri ngezikhathi ezithile kuba i-Xeljanz ingabangela utshintsho kwiintlobo ezithile zeeseli ezimhlophe zegazi, i-hemoglobin, i- enzymes yesibindi kunye neepidids; izigulane ezithatha i-Xeljanz akufanele zifumane iigciwane eziphilayo.
Izifundo ezifanelekileyo zeXeljanz kwabasetyhini abakhulelweyo azizange zenziwe. I-Xeljanz kufuneka isetyenziswe kuphela ngexesha lokukhulelwa xa inzuzo yesilwanyana iphakamisa umngcipheko omkhulu kumntwana.
Iindleko
I-Xeljanz iya kuba neendleko zokufumana i-$ 2,055.13 yee-total for 30-day supply (okanye i-$ 24,666 ngonyaka).
Iindleko zezigulane ziyahlukahluka kuxhomekeke kwiikontraka kunye ne-inshorensi.
> Imithombo:
> Xeljanz. Ukunyathelisa ngokupheleleyo iNgcaciso kunye neNkxaso yamayeza. Ukuhlaziywa 02/2016.
> Ulawulo lwe-US kunye noLawulo lweeDrug luyavuma i-XfiJANZ ye-XfiJANZ (tofacitinib citrate) yabadala abakwi-Modestly to Actively Rheumatoid Arthritis (RA) Ngubani oye waba neempendulo ezingafanelekanga okanye ukungaboni ngaso linye kwi-Methotrexate. 11/06/2012.
> Xeljanz, i-Pfizer ye-Pfizer ye-A-Year-A-A-A-A-A-A-A-Increased Arthritis, ifumana i-FDA Green Light. UMatewu Herper. Forbes.com. 11/06/2012.