I-Dajectable Drug ye-Plaque Psoriasis ne-Psoriatic Arthritis
I-Stelara (ustekinumab), inyeza yeyeza ye-biologic , ivunyiwe yi-US Food and Drug Administration (FDA) ngoSeptemba 25, 2009, ukwenzela unyango lwe- psoriasis eqingqiweyo kubantu abadala. I-plaque psoriasis, echaphazela abantu abayizigidi ezi-6 e-US, yimeko ye-immune system eyenza ukukhutshwa kwe-cell cell.
I-plaque psoriasis ibonakaliswe ngophawu oluxubileyo lwesikhumba esibomvu, obusibhakabhaka, obuqheleke ngokukhawuleza ngezikali ezibonakala zi-silvery. Izifundo ezintathu ezibandakanya izigulane ezingama-2,266 zivavanya ukhuseleko kunye nokusebenza kwe-Stelara, ekugqibeleni zikhokelela ekuvunyelweni kwayo kwi-psqueasis ye-plaque.
Kwiminyaka emine kamva, ngoSeptemba 23, 2013, kwaziswa ukuba i-FDA iphinde ivume iStelara, yodwa okanye inxulumene ne- methotrexate , ukwenzela unyango lwabaguli abadala abane- arthritis esebenzayo. Abantu abangaphezu kwezigidi ezi-2 e-US banempilo yesifo se-psoriatic, isifo esizimeleyo esichazwe ngokutshabalala kunye kunye nomonakalo ohlangeneyo, kunye nezilonda zesikhumba ezihambisana ne-psoriasis. Izigulana ezimbini ezibalulekileyo ze-III ze-III, i-double-blind, i-randomized, i-placebo elawulwa yizilingo (PSUMMIT I kunye ne-PSUMMIT II) ezibandakanya izigulane ezingama-927 ezine-arthritis ze-psoriatic zivavanya ukhuseleko kunye nokusebenza kwe-Stelara kwaye zakhokelela ekuvunyelweni kwayo.
UJanssen Biotrech, Inc. wafumanisa waza wenza iStelara. Umenzi weziyobisi unamalungelo okuthengisa okuthe ngqo kumachiza e-US I-Janssen Pharmaceutical Companies zinegunya lokuthengisa ngokuthe ngqo.
Yintoni uStralara?
I-Stelara yi- antioclonal antibody . Ngokukodwa, uStela ungumntu onxamnye no-interleukin ojolise kwi-IL-12 kunye ne-IL-23, iiprotheni ezimbini ezicingelwa ukuba zidlala indima kwiimeko ezithile zokuvuvukala, kuquka i-psoriasis kunye ne-psoriatic arthritis.
Ukusetyenziswa kweMithi
I-Stelara ilawulwa njenge-injection subcutaneous (oko kukuthi, phantsi kwesikhumba). Izigulane ze-psoriasis ezilinganisa i-lbs 220. (100 kg.) Okanye ngaphantsi, i-dose yokuqala yokucetyiswa kunye nomthamo olandelayo kwiiveki ezi-4 ngu-45 mg., Ilandelwa ngu-45 mg. kwiiveki ezili-12. Kwizigulane ezinomlinganiselo ongaphezulu kwama-220 lbs. (100 kg.), I-dose yokuqala yokucetyiswa kunye nomthamo olandelayo kwiiveki ezi-4 ngu 90 mg., Ilandelwa ngu-90 mg. kwiiveki ezili-12.
Kwizigulane ezine-arthritis ye-psoriatic, i-dose ekhuthazwayo ye-Stelara ngu-45 mg. ekuqaleni kwaye kwiiveki ezi-4, zilandelwa ngu-45 mg. kwiiveki ezili-12. Kwizigulane ezine-plaque psoriasis kunye ne-psoriatic arthritis kwaye zilinganise ngaphezu kwe-220 lbs., I-dose yasekuqaleni ephakanyisiweyo kunye neDiski emva kweeveki ezine-90 mg, ilandelwa ngu-90 mg. kwiiveki ezili-12.
I-Stelara ifumaneka kwi-45 mg / 0.5mL esisetyenziswayo esisodwa, isirinji esengaphambili egcwalisiweyo kunye ne-90 mg / mL yokusetyenziswa kwesirinji enye ngaphambi kokuzaliswa. I-Stelara ifumaneka kwiivalo zokusebenzisa esisodwa kunye ne-45 mg / 0.5mL okanye 90 mg / mL kaStelara.
Ngubani ongafanele asebenzise iStralara
Abantu abane-hypersensitivity eyaziwayo kwi-ustekinumab okanye izithako ezingasebenziyo kwi-Stelara akufanele basebenzise loo mveliso. Izithako ezingasebenziyo ziquka uL-histidine, uL-histidine monohydrochloride monohydrate, i-polysorbate 80 kunye ne-sucrose.
Iziphumo eziPhakathi
Iziphumo eziqhelekileyo ezichaphazelekayo kunye ne-Stelara ziquka i-nasopharyngitis, izifo eziphezulu zokuphefumula, intloko yesifo kunye nokukhathala. Ezinye iziphumo ezichaphazelekayo zinokwenzeka. Thetha ugqirha ukuba ufumana nawuphi na umonakalo onokuthi unxulumane noStelara.
Izilumkiso kunye nokuqapha
I-Stelara inokunyusa umngcipheko wezosuleleko kunye nokuvuselelwa kweentsholongwane ezingasebenzi (ezingasebenzi okanye ezilele). Kwizilingo zeklinikhi, izifo ezinobungozi obukhulu, izifo zentsholongwane kunye neentsholongwane zentsholongwane zigcinwe kwezinye izigulane zonyangwa ngo-Stelara. Isilwanyana akufanele sinikezwe isigulane esinentsholongwane echaphazelekayo kwaye kufuneka siqwalaselwe ngenyameko kwizigulane ezineentsholongwane ezingapheliyo okanye imbali yentsholongwane ebalulekileyo okanye ephindaphindiweyo.
Ngaphambi kokuqalisa unyango kunye noSterara, izigulane kufuneka zihlolwe isifo sofuba (TB) . Unyango lwe-TB ephambili kufuneka ulandele unyango ngo-Stelara.
Ngokusekelwe kwizilingo zonyango, umngcipheko wesifo sonyango unganyuswa kunye nokusetyenziswa kwe-Stelara. Kukho kwakhona iirekhodi ezithunyelwe ngeposi ngokukhawuleza kweembonakalo ezininzi ze-squamous cell carcinoma kwizigulane eziphathwe no-Stelara ababengumngcipheko we- non-melanoma yomhlaza wesikhumba . Zonke izigulane eziphathwe nge-Stelara zimele zibekwe iliso ngenxa yomhlaza wesiqhumane esingenayo i-melanoma.
Ukuphendulwa kwe-Hypersensitivity (umzekelo, i- anaphylaxis kunye ne- angioedema ) kuye kwaphawulwa kwii-postmarketing reports. Ukuba oko kwenzeka, unyango olufanelekileyo lufanele lunikezwe ukuxazulula ukusabela kwamagciwane kunye neStrala kufuneka inqunywe.
Elinye icala le-Reversible Posterior Leukoencephalopathy Syndrome labikwa kwisigulane esamkele amayeza angama-12 kaStera ngaphezu kweminyaka emibini. Isigulane safumana ngokupheleleyo unyango kunye nokucinywa kwe-Stelara.
Izigulane eziphathwe ngo-Stelara akufanele zifumane iigciwane eziphilayo, kwaye akufuneki nabani na ekhaya. Izigulane akufanele zithole i-BCG (Bacille Calmette Guerin) yokugonywa kunyaka owodwa ngaphambi kokuba unyango kunye noStelara okanye unyaka owodwa emva kokuba uStelara amekile.
Akuzange kubekho uphando olwaneleyo okanye olulawulwa kakuhle lwe-Stelara ekusebenziseni kwabasetyhini abakhulelweyo okanye abahlengikazi. Ukuze isetyenziswe ngexesha lokukhulelwa okanye xa unesihlengikazi, inzuzo kufuneka ibe ngaphezu komngcipheko ongasenokuba ngumntwana.
Imithombo:
Stelara. Ulwaziso loLwazi. Ukuhlaziywa 03/2014.
I-FDA iyavuma i-Stelara. Drugs.com. Septemba 2009.
U-Stelara (ustekinumab) Ufumana imvume ye-FDA yokuphatha iArthritis esebenzayo ye-Psoriatic. Septemba 2013.