Inaliti ye-Ixekizumab

-Delile

• Ngaphambi kokusebenzisa umjovo we-ixekizumab,
• Umjovo we-Ixekizumab ungadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma lezo ezisohlwini lwe-SPECIAL PRECAUTIONS section, yeka ukusebenzisa umjovo we-ixekizumab bese ushayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo

Umjovo we-Ixekizumab usetshenziselwa ukwelapha i-plaque psoriasis ngokulinganisela (isifo sesikhumba lapho kwakhiwa khona amabala abomvu, anezikhala ezindaweni ezithile zomzimba) kubantu abadala nezingane ezineminyaka engu-6 ubudala nangaphezulu i-psoriasis yayo enzima kakhulu ukuthi ingalashwa ngemithi yezinhlayiya. yedwa. Ibuye isetshenziswe yodwa noma ihlanganiswe nemithi ethile efana ne-methotrexate (Rasuvo, Trexall, abanye) ukwelapha i-psoriatic arthritis (isimo esidala ubuhlungu bamalunga nokuvuvukala nezikali esikhumbeni) kubantu abadala. Umjovo we-Ixekizumab ubuye usetshenziselwe ukwelapha i-ankylosing spondylitis (isimo lapho umzimba uhlasela khona amalunga omgogodla nezinye izindawo, okudala ubuhlungu nokulimala ngokuhlanganyela) kubantu abadala. Ibuye isetshenziselwe ukwelapha i-axial spondyloarthritis (i-axial spondyloarthritis) esebenzayo (isimo lapho umzimba uhlasela khona amalunga omgogodla nezinye izindawo okwenza ubuhlungu nezimpawu zokuvuvukala, kepha ngaphandle kwezinguquko ezibonakala ku-x-ray) kubantu abadala, umjovo we-Ixekizumab ekilasini lemithi ebizwa ngama-antibody monoclonal. Isebenza ngokuvimba ukusebenza kwento ethile yemvelo emzimbeni edala izimpawu ze-psoriasis.

Umjovo we-Ixekizumab uza njengesisombululo (uketshezi) kusirinji ekhethiwe futhi njenge-autoinjector ekhethiwe yokujova ngomgogodla (ngaphansi kwesikhumba). Ukwelapha i-plaque psoriasis kubantu abadala, imvamisa inikezwa njengemijovo emibili yomthamo wokuqala, ilandelwe umjovo owodwa njalo emavikini ama-2 ngamanani ayisithupha alandelayo, bese kuba umjovo owodwa njalo emavikini amane. Ukwelapha i-plaque psoriasis ezinganeni, imvamisa inikezwa njengomjovo owodwa noma emibili yomthamo wokuqala, ngokuya ngesisindo sengane, kulandele umjovo owodwa njalo emavikini amane. Ukwelapha i-psoriatic arthritis noma i-ankylosing spondylitis, imvamisa inikezwa njengemijovo emibili yomthamo wokuqala, ilandelwe umjovo owodwa njalo emavikini amane. Ukwelapha i-non-radiographic axial spondyloarthritis, imvamisa inikezwa njengomjovo owodwa njalo emavikini amane.

Ungathola umthamo wakho wokuqala womjovo we-ixekizumab ehhovisi likadokotela wakho. Uma ungumuntu omdala, udokotela wakho angakuvumela noma umnakekeli enze imijovo ye-ixekizumab ekhaya ngemuva komthamo wakho wokuqala. Uma unenkinga yokubona noma yokuzwa, uzodinga umnakekeli ukuze akujove. Uma ingane yakho inesisindo esingamakhilogremu ayi-110 (50 kg) noma ngaphansi, umjovo we-ixekizumab kufanele unikezwe ehhovisi likadokotela. Uma ingane yakho inesisindo esingaphezu kwamakhilogremu ayi-110, udokotela wakho angavumela umnakekeli ukuthi enze imijovo ekhaya. Cela udokotela wakho noma usokhemisi ukuthi akubonise noma umuntu ozobe ejova umuthi ukuthi ungawujova kanjani futhi uwulungiselele.

Sebenzisa i-syringe ngayinye noma i-autoinjector kanye kuphela bese ujova sonke isisombululo esirinji noma i-autoinjector. Lahla imijovo esetshenzisiwe ne-autoinjector esitsheni esingamelana nokubhoboza. Khuluma nodokotela wakho noma usokhemisi mayelana nokuthi ungasilahla kanjani isitsha esingamelana nokubhoboza.

Susa isirinji noma i-autoinjector efakwe efrijini. Yibeke endaweni eyisicaba ngaphandle kokususa ikepisi lenaliti bese uyivumela ifudumele ekamelweni lokushisa imizuzu engama-30 ngaphambi kokuba ulungele ukujova umuthi. Ungazami ukufudumeza umuthi ngokuwufudumeza ngemicrowave, uwufake emanzini ashisayo, uwushiye elangeni, noma nganoma iyiphi enye indlela.

Unganyakazisi isirinji noma i-autoinjector equkethe i-ixekizumab.

Njalo bheka isixazululo se-ixekizumab ngaphambi kokusijova. Hlola ukuthi usuku lokuphelelwa yisikhathi aludlulanga nokuthi uketshezi lucacile noma luphuzi kancane. Uketshezi akufanele luqukethe izinhlayiya ezibonakalayo. Ungasebenzisi isirinji noma i-autoinjector uma iqhekekile noma iphukile, uma iphelelwe yisikhathi noma iqandisiwe, noma uma uketshezi lunamafu noma luqukethe izinhlayiya ezincane.

Ungajova umjovo we-ixekizumab noma yikuphi ngaphambili kwamathanga akho (umlenze ongaphezulu) noma isisu (isisu) ngaphandle kwenkaba yakho nendawo eyi-1 intshi (2.5 centimeters) ezungezile. Uma unomnakekeli wokujova umuthi, ingemuva lengalo engaphezulu nayo ingasetshenziswa. Ukwehlisa amathuba okuba buhlungu noma okubomvu, sebenzisa isiza esihlukile ngomjovo ngamunye. Ungafaki endaweni lapho isikhumba sithambile, silimele, sibomvu, noma siqinile noma lapho unezibazi noma izimpawu zokwelula. Musa ukujova ixekizumab endaweni ethintwe yi-psoriasis.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha Nemiyalo Yokusetshenziswa) lapho uqala ukwelashwa ngomjovo we-ixekizumab futhi isikhathi ngasinye lapho ugcwalisa umuthi wakho. Funda imininingwane ngokucophelela bese ubuza udokotela noma usokhemisi wakho uma unemibuzo. Ungavakashela futhi iwebhusayithi ye-Food and Drug Administration (FDA) (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) ukuthola uMhlahlandlela Wezokwelapha, noma iwebhusayithi yomkhiqizi ukuthola uMhlahlandlela Wezokwelapha kanye Nemiyalo Ukusetshenziswa.

Lo muthi ungabekelwa okunye ukusetshenziswa; buza udokotela wakho noma usokhemisi ukuthola eminye imininingwane.

Ngaphambi kokusebenzisa umjovo we-ixekizumab,

• Tshela udokotela kanye nosokhemisi wakho uma une-aleji ku-ixekizumab, noma imuphi omunye umuthi, noma iziphi izithako zomjovo we-ixekizumab. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi imishanguzo kadokotela neyokungabhalisi, amavithamini, izithako zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Qiniseka ukuthi usho noma yikuphi okulandelayo: carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), cyclosporine (Gengraf, Neoral, Sandimmune), quinidine (eNuedexta), sirolimus (Rapamune), tacrolimus (Astagraf, Envarsus, Prograf) , kanye ne-warfarin (Coumadin, Jantoven). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi. Eminye imishanguzo eminingi ingaxhumana nomjovo we-ixekizumab, ngakho-ke qiniseka ukuthi utshela udokotela wakho ngayo yonke imithi oyiphuzayo, ngisho naleyo engabonakali kulolu hlu.
• Tshela udokotela wakho uma unesifo noma unezifo ezivuthayo zamathumbu (IBD; iqembu lezimo ezibangela ukuvuvukala kolwelwesi lwamathumbu) njengesifo sikaCrohn (isimo lapho umzimba uhlasela khona ulwelwesi lomgudu wokugaya ukudla, obangela ubuhlungu, isifo sohudo, ukwehla kwesisindo, nomkhuhlane) noma i-ulcerative colitis (isimo esidala ukuvuvukala nezilonda kulwelwesi lwekholoni [amathumbu amakhulu] ne-rectum).
• tshela udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uma ukhulelwa ngenkathi usebenzisa umjovo we-ixekizumab, shayela udokotela wakho.
• thintana nodokotela wakho ukuze ubone uma ngabe udinga ukuthola noma yimiphi imigomo. Kubalulekile ukuthi yonke imishanguzo yokugoma ilungele iminyaka yakho ngaphambi kokuqala ukwelashwa kwakho ngomjovo we-ixekizumab. Ungabi nayo imigomo ngesikhathi sokwelashwa kwakho ngaphandle kokukhuluma nodokotela wakho.
• kufanele wazi ukuthi umjovo we-ixekizumab unganciphisa ikhono lakho lokulwa nokutheleleka kusuka kubhaktheriya, amagciwane, nesikhunta futhi kwandise ingozi yokuthi uzothola ukutheleleka okuyingozi noma okusongela impilo. Tshela udokotela wakho uma uvame ukuthola noma yiluphi uhlobo lokutheleleka noma uma une noma ucabanga ukuthi ungahle ube nolunye uhlobo lokutheleleka manje. Lokhu kufaka ukutheleleka okuncane (njengokusikeka okuvulekile noma izilonda), izifo ezifika zidlule (njenge-herpes noma izilonda ezibandayo), kanye nezifo ezingapheli ezingapheli. Uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi noma ngemuva nje kokwelashwa kwakho ngomjovo we-ixekizumab, shayela udokotela wakho ngokushesha: umkhuhlane, ukujuluka, noma ukubanda, izinhlungu zemisipha, ukuphelelwa umoya, ukufudumala, okubomvu, noma okubuhlungu kwesikhumba noma izilonda emzimbeni wakho uhudo, ubuhlungu besisu, ukuchama kaningi, okuphuthumayo noma okubuhlungu, noma ezinye izimpawu zokutheleleka. Udokotela wakho mhlawumbe uzobambezela ukwelashwa kwakho ngomjovo we-ixekizumab uma unesifo.
• kufanele wazi ukuthi ukusebenzisa umjovo we-ixekizumab kwandisa ubungozi bokuthi uzoba nesifo sofuba (i-TB; ukutheleleka okungathi sína kwamaphaphu), ikakhulukazi uma usuvele ungenwe yisifo sofuba kodwa ungenazo izimpawu zesifo. Tshela udokotela wakho uma uke waba ne-TB noma wake waba nayo, uma ngabe uhlala ezweni lapho i-TB ijwayelekile khona, noma uma wake waba seduze komuntu one-TB. Udokotela wakho uzokuhlolela isikhumba ukuze abone ukuthi une-TB engasebenzi yini. Uma kunesidingo, udokotela wakho uzokunika imithi yokwelapha lesi sifo ngaphambi kokuqala ukusebenzisa umjovo we-ixekizumab. Uma unezinye zalezi zimpawu ezilandelayo ze-TB, noma uma uba nalezi zimpawu phakathi nokwelashwa kwakho, shayela udokotela wakho ngokushesha: ukukhwehlela, ukukhwehlela igazi noma amafinyila, ubuthakathaka noma ukukhathala, ukuncipha komzimba, ukulahlekelwa isifiso sokudla, ukugodola, umkhuhlane , noma ukujuluka ebusuku.

Ngaphandle kokuthi udokotela wakho akutshele ngenye indlela, qhubeka nokudla okuvamile.

Sebenzisa umthamo ongabanjwanga ngokushesha nje lapho uwukhumbula bese uqhubeka nesimiso sakho sokulinganisa okuvamile. Ungasebenzisi umthamo ophindwe kabili ukwenza okulahlekile.

Umjovo we-Ixekizumab ungadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• isicanucanu
• amehlo abomvu, alumayo noma anamanzi
• ikhala eligcwele noma eligijimayo
• ububomvu noma ubuhlungu endaweni yomjovo
• ubuhlungu besisu
• isifo sohudo (noma ngaphandle kwegazi)
• ukuncipha komzimba

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nanoma yiziphi zalezi zimpawu noma lezo ezisohlwini lwe-SPECIAL PRECAUTIONS section, yeka ukusebenzisa umjovo we-ixekizumab bese ushayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo

• ngizizwe ngiphela amandla
• ukuvuvukala kobuso, amajwabu amehlo, ulimi, noma umphimbo
• ubunzima bokugwinya noma ukuphefumula
• ukuqina esifubeni noma emphinjeni
• ukuqubuka
• isifuba

Umjovo we-Ixekizumab ungadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi usebenzisa lo muthi.

Uma uthola imiphumela emibi kakhulu, wena noma udokotela wakho ungathumela umbiko kuhlelo lwe-Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting online (http://www.fda.gov/Safety/MedWatch) noma ngocingo ( 1-800-332-1088).

Gcina le mithi esitsheni efike kuyo ukuyivikela ekukhanyeni, ivalwe ngokuqinile, futhi ingafinyeleleki ezinganeni. Gcina umjovo we-ixekizumab esiqandisini, kepha ungawumisi. Uma kudingeka, ungagcina umjovo we-ixekizumab ekamelweni lokushisa kuze kube yizinsuku ezi-5 kwikhathoni lokuqala ukuwuvikela ekukhanyeni. Uma usugcinwe ekamelweni lokushisa, ungabuyiseli umjovo we-ixekizumab esiqandisini. Lahla umjovo we-ixekizumab uma ungasetshenziswa zingakapheli izinsuku ezi-5 ekamelweni lokushisa.

Kubalulekile ukugcina yonke imishanguzo ingabonakali futhi ifinyeleleke ezinganeni njengoba iziqukathi eziningi (njengezingqondo zamaphilisi zamasonto onke kanye nalawo amaconsi wamehlo, okhilimu, amabala, kanye nama-inhalers) azimeleki ezinganeni futhi izingane ezincane zingazivula kalula. Ukuvikela izingane ezisencane ekufakeni ubuthi, hlala uvala amakepisi okuphepha bese ubeka umuthi endaweni ephephile - eyodwa ephezulu futhi engekho futhi engabonakali kubo futhi efinyelela kuyo. http://www.upandaway.org

Imithi engadingeki kufanele ilahlwe ngezindlela ezikhethekile zokuqinisekisa ukuthi izilwane ezifuywayo, izingane nabanye abantu abakwazi ukuzidla. Kodwa-ke, akufanele ukhiphe le mithi ethoyilethi. Esikhundleni salokho, indlela engcono kakhulu yokulahla imithi yakho ngohlelo lokubuyisa umuthi. Khuluma nosokhemisi wakho noma uthinte umnyango wangakini wokulahla udoti / wokusebenzisa kabusha ukuze ufunde ngezinhlelo zokubuyisa emphakathini wakho. Bheka iwebhusayithi yakwa-FDA's Safe Disposal of Medicines (http://goo.gl/c4Rm4p) ukuthola eminye imininingwane uma ungakwazi ukufinyelela kuhlelo lokubuyisa.

Uma kwenzeka ukweqisa ngokweqile, shayela ucingo losizo lokulawula ubuthi ku-1-800-222-1222. Imininingwane iyatholakala online ku-https: //www.poisonhelp.org/help. Uma isisulu siwile, saba nokuquleka, sinenkinga yokuphefumula, noma singakwazi ukuvuswa, shayela ngokushesha abezimo eziphuthumayo ku-911.

Gcina wonke ama-aphoyintimenti nodokotela wakho.

Ixekizumab autoinjector inezingxenye zengilazi futhi kufanele iphathwe ngokucophelela. Uma i-autoinjector iwela endaweni elukhuni, ungayisebenzisi.

Ungavumeli omunye umuntu asebenzise imithi yakho. Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana nokugcwalisa umuthi wakho.

Kubalulekile ukuthi ugcine uhlu olubhaliwe lwayo yonke imishanguzo oyisebenzisayo kadokotela kanye nokungabhaliswanga (ngaphezulu kokuthenga), kanye nanoma yimiphi imikhiqizo efana namavithamini, amaminerali, noma ezinye izithako zokudla. Kufanele uze nalolu hlu njalo uma uvakashela udokotela noma uma ungeniswa esibhedlela. Kubaluleke kakhulu futhi nemininingwane ebalulekile ukuthi uphathe uma kwenzeka kunezimo eziphuthumayo.

• I-Taltz^®