Inaliti yeNatalizumab

-Delile

• I-Natalizumab isetshenziselwa ukuvimbela iziqephu zezimpawu futhi yehlise ukwanda kokukhubazeka kubantu abadala abanamafomu abuyela emuva e-multiple sclerosis (MS; isifo lapho izinzwa zingasebenzi kahle futhi abantu bangathola ubuthakathaka, ukuba ndikindiki, ukulahleka kokuhlangana kwemisipha, futhi izinkinga ngombono, ukukhuluma, nokulawula isinye), kufaka phakathi:
• Ngaphambi kokuthola umjovo we-natalizumab,
• I-Natalizumab ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nalezi zimpawu ezilandelayo noma lezo ezishiwo esigabeni SOKUXWAYISA noma ESIBALULEKILE, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

Ukuthola umjovo we-natalizumab kungakhuphula ubungozi bokuthi uzoba ne-leukoencephalopathy eqhubekayo (i-PML), ukutheleleka okungajwayelekile kobuchopho okungakwazi ukwelashwa, ukuvinjelwa, noma ukwelashwa okuvame ukudala ukufa noma ukukhubazeka okukhulu). Ithuba lokuthi uzoba ne-PML ngesikhathi ukwelashwa kwakho ne-natalizumab liphakeme uma unenkinga eyodwa noma eziningi ezilandelayo.

• Uthole amanani amaningi we-natalizumab, ikakhulukazi uma uthole ukwelashwa isikhathi esingaphezu kweminyaka emi-2.
• Wake waphathwa ngemithi ethena amandla amasosha omzimba, kufaka phakathi i-azathioprine (Azasan, Imuran), cyclophosphamide, methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), mitoxantrone, ne-mycophenolate mofetil (CellCept).
• Ukuhlolwa kwegazi kukhombisa ukuthi usuchayeke ku-John Cunningham virus (i-JCV; igciwane abantu abaningi abalichayeka ebuntwaneni ngokuvamile elingadali zimpawu kepha elingadala i-PML kubantu abanamasosha omzimba abuthakathaka).

Udokotela wakho mhlawumbe uzo-oda ukuhlolwa kwegazi ngaphambi noma ngesikhathi sokwelashwa kwakho ngomjovo we-natalizumab ukubona ukuthi ngabe uvezwe i-JCV. Uma ukuhlolwa kubonisa ukuthi uvulelwe i-JCV, wena nodokotela wakho ninganquma ukuthi akufanele nithole umjovo we-natalizumab, ikakhulukazi uma ninayo eyodwa noma zombili lezi zinto eziyingozi ezibalwe ngenhla. Uma ukuhlolwa kungakhombisi ukuthi uvezwe ku-JCV, udokotela wakho angaphinda isivivinyo ngezikhathi ezithile ngesikhathi sokwelashwa kwakho ngomjovo we-natalizumab. Akufanele uhlolwe uma ngabe uke washintshaniswa nge-plasma (ukwelashwa lapho kukhishwa khona ingxenye engamanzi yegazi emzimbeni kwafakwa ezinye uketshezi) emasontweni amabili edlule ngoba imiphumela yokuhlolwa kwayo ngeke ibe nenembile.

Kunezinye izinto ezingakhuphula nobungozi bokuthi uzoba ne-PML. Tshela udokotela wakho uma uke waba ne-PML noma uke waba ne-PML, noma esinye isimo esithinta amasosha akho omzimba njenge-human immunodeficiency virus (HIV), i-immunodeficiency syndrome (i-AIDS), i-leukemia (umdlavuza obangela amangqamuzana amaningi egazi ukhiqizwe futhi ukhishwe ungene egazini), noma i-lymphoma (umdlavuza ovela kumaseli amasosha omzimba). Tshela nodokotela wakho uma uthatha noma ngabe wake waphuza noma imuphi omunye umuthi othinta amasosha omzimba njenge-adalimumab (Humira); i-cyclosporine (Gengraf, Neoral, Sandimmune); i-etanercept (Enbrel); i-glatiramer (iCopaxone, iGlatopa); infliximab (i-Remicade); i-interferon beta (Avonex, Betaseron, Rebif); imithi yomdlavuza; i-mercaptopurine (iPurinethol, iPurixan); i-steroids yomlomo efana ne-dexamethasone, i-methylprednisolone (i-Depo-medrol, i-Medrol, i-Solu-medrol), i-prednisolone (i-Prelone), ne-prednisone (i-Rayos); i-sirolimus (i-Rapamune); ne-tacrolimus (i-Astagraf, i-Envarsus XR, i-Prograf). Udokotela wakho angakutshela ukuthi akufanele uthole umjovo we-natalizumab.

Uhlelo olubizwa ngohlelo lwe-TOUCH lubekiwe ukusiza ukuphatha izingozi zokwelashwa kwe-natalizumab. Ungathola umjovo we-natalizumab kuphela uma ubhaliswe nohlelo lwe-TOUCH, uma ngabe i-natalizumab ikunikeze udokotela obhalisiwe nohlelo, futhi uma uthola umuthi esikhungweni sokumnika esibhalisiwe nohlelo. Udokotela wakho uzokunikeza imininingwane ethe xaxa ngalolu hlelo, uzokusayina ifomu lokubhalisa, futhi uzokuphendula noma imiphi imibuzo onayo mayelana nohlelo nokwelashwa kwakho ngomjovo we-natalizumab.

Njengengxenye yohlelo lwe-TOUCH, udokotela wakho noma umhlengikazi uzokunikeza ikhophi ye-Medication Guide ngaphambi kokuba uqale ukwelashwa ngomjovo we-natalizumab nangaphambi kokuthola ukumnika ngakunye. Funda lolu lwazi ngokucophelela njalo uma uluthola bese ubuza udokotela noma unesi wakho ukuthi unemibuzo ethile yini. Ungavakashela futhi iwebhusayithi ye-Food and Drug Administration (FDA) (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) noma iwebhusayithi yomkhiqizi ukuthola i-Medication Guide.

Futhi njengengxenye yohlelo lwe-TOUCH, udokotela wakho uzodinga ukukubona njalo ezinyangeni ezi-3 ekuqaleni kokwelashwa kwakho futhi okungenani njalo ezinyangeni eziyisithupha ukunquma ukuthi kufanele uqhubeke usebenzisa i-natalizumab. Uzodinga futhi ukuphendula eminye imibuzo ngaphambi kokuthola ukumnika ngakunye ukuze uqiniseke ukuthi i-natalizumab isakulungele.

Shayela udokotela wakho ngokushesha uma uba nezinkinga ezintsha noma eziya ziba zimbi zezokwelapha ngesikhathi sokwelashwa kwakho, nezinyanga eziyisithupha ngemuva komthamo wakho wokugcina. Qiniseka ngokukhethekile ukuthi ushayele udokotela wakho uma uhlangabezana nalezi zimpawu ezilandelayo: ubuthakathaka ohlangothini olulodwa lomzimba oluba kubi ngokuhamba kwesikhathi; ubulukhuni bezingalo noma bemilenze; izinguquko ekucabangeni kwakho, kwimemori, ekuhambeni, ekulinganiseni, ekukhulumeni, ekubukeni kwamehlo, noma emandleni okuhlala izinsuku ezimbalwa; ikhanda; ukuquleka; ukudideka; noma izinguquko zobuntu.

Uma ukwelashwa kwakho ngomjovo we-natalizumab kumiswa ngoba une-PML, ungahle uhlakulele esinye isimo esibizwa nge-immune reconstitution inflammatory syndrome (i-IRIS; ukuvuvukala nokuwohloka kwezimpawu ezingase zivele njengoba amasosha omzimba eqala ukusebenza futhi ngemuva kokuqala kwemithi ethile ewuthintayo. noma umisiwe), ikakhulukazi uma uthola ukwelashwa ukususa i-natalizumab egazini lakho ngokushesha okukhulu. Udokotela wakho uzokubheka ngokucophelela ukuthola izimpawu ze-IRIS futhi uzokwelapha lezi zimpawu uma zenzeka.

Tshela bonke odokotela abakwelapayo ukuthi uthola umjovo we-natalizumab.

Khuluma nodokotela wakho ngezingozi zokuthola umjovo we-natalizumab.

I-Natalizumab isetshenziselwa ukuvimbela iziqephu zezimpawu futhi yehlise ukwanda kokukhubazeka kubantu abadala abanamafomu abuyela emuva e-multiple sclerosis (MS; isifo lapho izinzwa zingasebenzi kahle futhi abantu bangathola ubuthakathaka, ukuba ndikindiki, ukulahleka kokuhlangana kwemisipha, futhi izinkinga ngombono, ukukhuluma, nokulawula isinye), kufaka phakathi:

• i-syndrome ehlukanisiwe nomtholampilo (i-CIS; isiqephu sesifo sezinzwa sokuqala esihlala okungenani amahora angama-24),
• isifo esibuyisa emuva (isifo esiyisifo lapho izimpawu zivela khona ngezikhathi ezithile),
• isifo esisebenzayo esiqhubekayo sesibili (isigaba sesifo esizayo ngokuqhubeka nokuba zimbi kwezimpawu.)

I-Natalizumab isetshenziselwa ukwelapha nokuvimbela iziqephu zezimpawu kubantu abadala abanesifo sikaCrohn (isimo lapho umzimba uhlasela ulwelwesi lomgudu wokugaya ukudla, ubangele ubuhlungu, isifo sohudo, ukuncipha komzimba nomkhuhlane) abangazange basizwe abanye imithi noma ngubani ongakwazi ukuthatha eminye imithi. INatalizumab isekilasini lemithi ebizwa ngama-antibody monoclonal. Isebenza ngokumisa amaseli athile omzimba omzimba ekufinyeleleni ebuchosheni nasentanjeni yomgogodla noma emgudwini wokugaya ukudla bese enza umonakalo.

INatalizumab iza njengesisombululo esigxilile (uketshezi) esizohlanjululwa futhi sijojwe kancane emthanjeni ngudokotela noma unesi. Imvamisa inikezwa kanye njalo emavikini amane kusikhungo esibhalisiwe sokumnika. Kuzothatha cishe ihora elilodwa ukuthi uthole wonke umthamo wakho we-natalizumab.

I-Natalizumab ingadala ukusabela okweqile okwenzeka emzimbeni okungenzeka kwenzeke kungakapheli amahora amabili ngemuva kokuqala kokufakwa, kepha kungenzeka nganoma yisiphi isikhathi lapho welashwa. Kuzofanele uhlale esikhungweni sokumnika ihora elingu-1 ngemuva kokuphela kokufakwa kwakho. Udokotela noma umhlengikazi uzokuqapha ngalesi sikhathi ukuze abone ukuthi awuphenduli yini emithini. Tshela udokotela noma umhlengikazi wakho uma uhlangabezana nezimpawu ezingajwayelekile ezinjengezinyosi, ukuqubuka, ukulunywa, ubunzima bokugwinya noma ukuphefumula, umkhuhlane, isiyezi, ikhanda elibuhlungu, ubuhlungu besifuba, ukuqhuma, isicanucanu, noma ukugodola, ikakhulukazi uma kwenzeka kungakapheli amahora amabili kuqalile ukumnika kwakho.

Uma uthola umjovo we-natalizumab welapha isifo sikaCrohn, izimpawu zakho kufanele zithuthuke ezinyangeni ezimbalwa zokuqala zokwelashwa kwakho. Tshela udokotela wakho uma izimpawu zakho zingakathuthuki ngemuva kwamasonto ayi-12 ekwelashwa. Udokotela wakho angayeka ukukuphatha ngomjovo we-natalizumab.

INatalizumab ingasiza ukulawula izimpawu zakho kepha ngeke iselaphe isimo sakho. Gcina konke ukuqokwa ukuthola umjovo we-natalizumab noma ngabe uzizwa uphilile.

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

Ngaphambi kokuthola umjovo we-natalizumab,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-natalizumab, noma imuphi omunye umuthi, noma iziphi izithako zomjovo we-natalizumab. Buza udokotela wakho noma usokhemisi uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi imishanguzo kadokotela nemishanguzo ongayinikiwe, amavithamini, izithasiselo zokudla okunempilo, nemikhiqizo yamakhambi oyiphuzayo. Qiniseka ukuthi uyayisho imithi efakwe kuhlu esigabeni ESIBALULEKILE SESEXWAYISO. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• utshele udokotela wakho ukuthi wake wahlatshwa yini umjovo we-natalizumab ngaphambili futhi uma uke noma uke waba nezimo ezithile ezibalwe esigabeni SESXWAYISO ESIBALULEKILE. Ngaphambi kokuthola ukumnika ngakunye kwe-natalizumab, tshela udokotela wakho uma unemfiva noma yiluphi uhlobo lokutheleleka, kufaka phakathi ukutheleleka okuhlala isikhathi eside njengama-shingles (ukuqubuka okungenzeka ngezikhathi ezithile kubantu abanenkukhu esedlule).
• utshele udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uma ukhulelwa ngenkathi uthola umjovo we-natalizumab, shayela udokotela wakho.
• ungenayo imigomo ngaphandle kokukhuluma nodokotela wakho.

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

Uma uphuthelwa i-aphoyintimenti yokuthola ukumnika kwe-natalizumab, shayela udokotela wakho ngokushesha okukhulu.

I-Natalizumab ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ikhanda
• ukukhathala ngokweqile
• ukozela
• ubuhlungu obuhlangene noma ukuvuvukala
• ubuhlungu ezingalweni noma emilenzeni
• ukuhlungu obusemhlane
• ukuvuvukala kwezingalo, izandla, izinyawo, amaqakala, noma imilenze engezansi
• amajaqamba
• ubuhlungu besisu
• isifo sohudo
• isilungulela
• ukuqunjelwa
• igesi
• ukuzuza kwesisindo noma ukwehla
• ukudana
• ukujuluka ebusuku
• ukuya esikhathini okubuhlungu, okungajwayelekile, noma okungabanjwanga (isikhathi)
• ukuvuvukala, ukubomvu, ukushisa, noma ukulunywa kwesitho sangasese sowesifazane
• ukukhishwa kwesitho sangasese sowesifazane esimhlophe
• ubunzima bokulawula ukuchama
• ubuhlungu bezinyo
• izilonda zomlomo
• ukuqubuka
• isikhumba esomile
• ukulunywa

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nalezi zimpawu ezilandelayo noma lezo ezishiwo esigabeni SOKUXWAYISA noma ESIBALULEKILE, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• umphimbo obuhlungu, umkhuhlane, ukukhwehlela, ukugodola, umkhuhlane njengezimpawu, amajaqamba esiswini, isifo sohudo, ukuchama kaningi noma okubuhlungu, isidingo sokuzichamela ngokushesha, noma ezinye izimpawu zokutheleleka
• ukuphuzi kwesikhumba noma kwamehlo, isicanucanu, ukuhlanza, ukukhathala ngokweqile, ukulahlekelwa isifiso sokudla, umchamo omnyama, izinhlungu zangaphezulu esiswini
• izinguquko zombono, ukubomvu kwamehlo, noma ubuhlungu
• ukopha okungajwayelekile noma ukulinyazwa
• amabala amancane, ayindingilizi, abomvu noma ansomi esikhunjeni
• ukuphuma kwegazi okunzima

Umjovo weNatalizumab ungadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthola 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).

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 kanye nelabhorethri. Udokotela wakho anga-oda izivivinyo ezithile zelebhu ukuze ahlole impendulo yomzimba wakho kumjovo we-natalizumab.

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.

• UTysabri^®