Isidakamizwa Esinayo I-Plaque Psoriasis ne-Psoriatic Arthritis
I-Stelara (ustekinumab), imishanguzo ye-biologic ejojeni, yamukelwa yi-US Food and Drug Administration (FDA) ngoSeptemba 25, 2009, ekwelapheni i- psoriasis enkulu yamathala kubantu abadala. I-plaque psoriasis, ethinta abantu abangaba yizigidi ezingu-6 e-US, isimiso sesimiso sokuzivikela komzimba esenza ukuthi kusetshenziswe ngokuphindaphindiwe kwama cell cell.
I-plaque psoriasis ibhekwa ngamagqabhagqagqagu ekhanda, abomvu obomvu, evame ukumbozwa ngezikali ezibonakala zi-silvery. Izifundo ezintathu ezibandakanya iziguli ezingu-2 266 zihlola ukuphepha nokusebenza kweStera, ekugcineni kuholela ekuvunyweni kwayo kwe-plaque psoriasis.
Eminyakeni emine kamuva, ngo-Septhemba 23, 2013, kwaziswa ukuthi i-FDA nayo ivume uStelara, eyedwa noma ehambisana ne- methotrexate , yokwelashwa kweziguli abadala abane- arthritis esebenzayo ye- psoriatic . Abantu abangaphezu kwezigidi ezingu-2 e-US bane-arthritis ye-psoriatic, isifo esizimele esisodwa esibonakala ukuvuvukala okuhlangene nomonakalo ohlangene, kanye nezilonda zesikhumba ezihambisana ne-psoriasis. Izivivinyo ezimbili eziyinhloko ze-Phase III ezinama-double-blind, randomized, ezilawulwa nge-placebo (PSUMMIT I no-PSUMMIT II) ezibandakanya iziguli ezingu-927 ezine-arthritis ye-psoriatic zihlola ukuphepha nokusebenza kwe-Stelara futhi zaholela ekuvunyweni kwayo.
UJanssen Biotrech, Inc. wathola futhi wasungula uStelara. Umenzi wezidakamizwa unamalungelo okuthengisa okukhethekile kumuthi wase-US I-Janssen Pharmaceutical Companies inamalungelo okukhangisa emhlabeni wonke okukhethekile.
Kuyini iStralara?
I-Stelara i -anti-monoglonal antibody . Ngokuqondile, u-Stelara ungumphikisi we-interleukin obhekisela ku-IL-12 no-IL-23, amaprotheni amabili acatshangwa ukuthi adlala indima ezimweni ezithile zokuvuvukala, kuhlanganise ne-psoriasis ne-psoriatic arthritis.
Indlela Imithi Ephathwa Ngayo
I-Stelara ilawulwa njengemjovo engaphansi (okungukuthi, ngaphansi kwesikhumba). Iziguli ze-psoriasis ezinesisindo esingu-220 lbs. (100 kg.) Noma ngaphansi, umthamo wokuqala wokunconywa kanye nesilinganiso esilandelayo emavikini angu-4 ngu-45 mg., Kulandelwa u-45 mg. njalo amasonto angu-12. Kuziguli ezilinganiselwa kuka-220 lbs. (100 kg.), Umthamo wokuqala wokunconywa kanye nomthamo olandelwayo emavikini angu-4 ngu-90 mg., Ilandelwa ngu-90 mg. njalo amasonto angu-12.
Kulezi ziguli ezine-arthritis ye-psoriatic, umthamo ophakanyisiwe we-Stelara ungama-45 mg. ekuqaleni futhi emavikini angu-4, kulandela 45 mg. njalo amasonto angu-12. Kulezi ziguli ezine-psoriasis yama-plaque kanye ne-psoriatic arthritis futhi ezilinganiselwa ezingaphezu kuka-220 lbs., Umthamo wokuqala wokunconywa kanye nomthamo wamaviki angu-4 kamuva u-90 mg., Ilandelwa ngu-90 mg. njalo amasonto angu-12.
I-Stelara itholakala ku-45 mg / 0.5mL ukusetshenziswa okukodwa, isirashi esandulele egcwalisiwe nasemgodini wokulinganisa ongakapheli osebenzayo ongama-90 mg / mL. I-Stelara itholakala nasezikhunjini zokusebenzisa ezilodwa eziqukethe ama-45 mg / 0.5mL noma 90 mg / mL we-Stelara.
Ubani Okungafanele Asebenzise I-Stelara
Abantu abane-hypersensitivity eyaziwayo ku-ustekinumab noma izithako ezingasebenziyo ku-Stelara akufanele basebenzise umkhiqizo. Izithako ezingasebenziyo zihlanganisa uL-histidine, i-L-histidine monohydrochloride monohydrate, i-polysorbate 80, ne-sucrose.
Imiphumela Ejwayelekile Ejwayelekile
Imiphumela emibi evamile ehambisana ne-Stelara ihlanganisa i-nasopharyngitis, izifo eziphezulu zokuphefumula, ukuphathwa ikhanda nokukhathala. Ezinye imiphumela emibi kungenzeka. Khuluma nodokotela wakho uma uhlangabezana nanoma yimiphi imiphumela emibi engase ihlobene noStelara.
Ukuxwayiswa nokuqapha
I-Stelara ingangandisa ingozi yezifo kanye nokuvuselelwa kwezifo ezingenalutho (ezingasebenzi noma ezilele). Ezilingo zomtholampilo, izifo ezinamandla ezibhekene ne-bacterial, fungal, kanye nesandulela ngculaza zazihlonishwa kwezinye iziguli eziphathwe uStelara. Isidakamizwa akufanele sinikezwe isiguli ngesifo esithathelwanayo futhi kufanele sicatshangelwe ngokucophelela ezigulini ezinegciwane elingelapheki noma umlando wezifo eziphuthumayo noma eziphindaphindiwe.
Ngaphambi kokuqala ukwelashwa nge-Stelara, iziguli kufanele zihlolwe isifo sofuba (i-TB) . Ukwelashwa kwe-TB evulekile kufanele kulandele ukwelashwa nge-Stelara.
Ngokususelwa ekuvivinyweni komtholampilo, ingozi yokulimala ingahle yande ngokusebenzisa uStelara. Kubuye kube nemibiko yokuthunyelwa kwe-postmarketing yokubonakala okusheshayo kwama-squamous cell carcinoma amaningi ezigulane eziphathwayo no-Stelara ababenezici eziyingozi ezingakaze zenzeke ngenxa yomdlavuza wesikhumba ongenayo i-melanoma . Zonke iziguli eziphathwe nge-Stelara kufanele zihlolwe ngenxa yomdlavuza wesikhumba ongenayo i-melanoma.
Ukusabela kwe-Hypersensitivity (isib., Anaphylaxis ne- angioedema ) kuye kwaphawulwa emibikweni yokuthunyelwa kwe-postmarketing. Uma lokhu kwenzeka, ukwelashwa okufanele kufanele kunikezwe ukuxazulula ukusabela kokucindezeleka futhi uStela kufanele akhiphe.
Isibonelo esisodwa se-Reversible Posterior Leukoencephalopathy Syndrome sabika esigulini esathola ama-12 amancane ka-Stelara ngaphezu kweminyaka emibili. Isiguli sabuyiselwa ngokugcwele ngokuphathwa kahle kanye nokuyeka kukaStelara.
Iziguli eziphathwe nge-Stelara akufanele zithole imithi ephilayo, futhi akufanele nanoma ubani ekhaya. Iziguli akufanele zithole umgomo we-BCG (Bacille Calmette Guerin) unyaka owodwa ngaphambi kokwelashwa no-Stelara noma unyaka owodwa emva kokuthi uStelara amisiwe.
Akuzange kube nokufundiswa okwanele noma okulawulwa kahle kokusetshenziswa kukaStela kubesifazane abakhulelwe noma abahlengikazi. Ukuze lisetshenziswe ngesikhathi sokukhulelwa noma ngenkathi kunesihlengikazi, inzuzo kufanele ikhuphule ingozi engaba khona enganeni.
Imithombo:
Stelara. Ukubeka imininingwane. Kubuyekezwe 03/2014.
I-FDA ivumela i-Stelara. Drugs.com. September 2009.
I-Stelara (ustekinumab) ithola imvume ye-FDA yokuphatha i-Active Psoriatic Arthritis. September 2013.