Inaliti yeNatalizumab

Umxholo

• I-Natalizumab isetyenziselwa ukuthintela iziqendu zeempawu kunye nokucothisa ukwanda kokukhubazeka kubantu abadala abathi baphinde baphinde baphume kwi-multiple sclerosis (MS; isifo apho imithambo-luvo ingasebenzi kakuhle kwaye abantu banokufumana ubuthathaka, ukuba ndindisholo, ukulahleka kwemisipha, kunye iingxaki ngombono, intetho, kunye nolawulo lwesinyi), kubandakanya:
• Ngaphambi kokufumana inaliti ye-natalizumab,
• I-Natalizumab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:
• Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu zilandelayo okanye ezo zikhankanywe kwicandelo LESILUMKISO okanye ELIBALULEKILEYO, tsalela ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

Ukufumana inaliti ye-natalizumab kunokunyusa umngcipheko wokuba uphuhlise i-leukoencephalopathy e-multifocal leukoencephalopathy (PML; usulelo olunqabileyo lobuchopho olungenakunyangwa, ukuthintelwa, okanye ukunyanga kwaye oko kuhlala kubangela ukufa okanye ukukhubazeka okunzima) Ithuba lokuba uya kuphuhlisa i-PML ngexesha lonyango lwakho kunye ne-natalizumab liphezulu ukuba unenye okanye nangaphezulu kwezi zinto zilandelayo zomngcipheko.

• Ufumene iidosi ezininzi ze-natalizumab, ngakumbi ukuba ufumene unyango ixesha elingaphezulu kweminyaka emi-2.
• Ukhe wanyangwa ngamayeza enza buthathaka amajoni omzimba, kubandakanya i-azathioprine (Azasan, Imuran), cyclophosphamide, methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), mitoxantrone, kunye mycophenolate mofetil (CellCept).
• Uvavanyo lwegazi lubonisa ukuba ubonakalisiwe kwintsholongwane kaJohn Cunningham (JCV; intsholongwane abantu abaninzi abayibonakaliseyo ebuntwaneni edla ngokungabonakalisi zimpawu kodwa inokubangela i-PML kubantu abanamajoni omzimba abuthathaka).

Ugqirha wakho uya kuthi aodole kuvavanyo lwegazi ngaphambi okanye ngexesha lonyango lwakho ngenaliti ye-natalizumab ukubona ukuba ubonakalisiwe kwi-JCV. Ukuba uvavanyo lubonisa ukuba ufumene i-JCV, wena kunye nogqirha wakho unokuthatha isigqibo sokuba awufanele ufumane inaliti ye-natalizumab, ngakumbi ukuba unayo okanye zombini ezinye izinto ezinobungozi ezidweliswe apha ngasentla. Ukuba uvavanyo alubonisi ukuba ubonakalisiwe kwi-JCV, ugqirha wakho unokuphinda uvavanyo amaxesha ngamaxesha ngexesha lonyango lwakho ngenaliti ye-natalizumab. Akufuneki kuvavanywe ukuba ubukhe watshintshiselana ngeplasma (unyango apho inkunkuma yegazi isuswe emzimbeni yaza yathatyathelwa indawo ngamanye ulwelo) kwezi veki zimbini zidlulileyo kuba iziphumo zovavanyo azizukuchaneka.

Kukho ezinye izinto ezinokuthi zonyuse umngcipheko wokuba uza kuphuhlisa i-PML. Xelela ugqirha wakho ukuba unayo okanye wakha wanayo i-PML, ukufakelwa ilungu, okanye enye imeko echaphazela amajoni akho omzimba njenge-virus ye-immunodeficiency virus (HIV), ifumene i-immunodeficiency syndrome (i-AIDS), i-leukemia (umhlaza obangela iiseli ezininzi zegazi iveliswe kwaye ikhutshelwe kwigazi), okanye i-lymphoma (umhlaza okhula kwiiseli zamajoni omzimba). Xelela ugqirha wakho ukuba uthatha okanye ukuba wakhe wathatha amanye amayeza achaphazela amajoni omzimba afana ne-adalimumab (Humira); icyclosporine (Gengraf, Neoral, Sandimmune); etanercept (Enbrel); I-glatiramer (iCopaxone, iGlatopa); infliximab (Remicade); I-beta ye-interferon (Avonex, Betaseron, Rebif); amayeza omhlaza; i-mercaptopurine (iPurinethol, iPurixan); i-steroids yomlomo efana ne-dexamethasone, i-methylprednisolone (i-Depo-medrol, i-Medrol, i-Solu-medrol), i-prednisolone (i-Prelone), kunye ne-prednisone (i-Rayos); i-sirolimus (iRapamune); kunye netacrolimus (Astagraf, Envarsus XR, Prograf). Ugqirha wakho unokukuxelela ukuba akufuneki ufumane inaliti ye-natalizumab.

Inkqubo ebizwa ngokuba yi-TOUCH program isetelwe ukunceda ukulawula ubungozi bonyango lwe-natalizumab. Unokufumana kuphela inaliti ye-natalizumab ukuba ubhalisile kwinkqubo ye-TOUCH, ukuba i-natalizumab imiselwe wena ngugqirha obhalisiweyo kule nkqubo, kwaye ukuba ufumana amayeza kwiziko lokumiliselwa elibhaliswe kwinkqubo. Ugqirha wakho uya kukunika ulwazi oluthe kratya malunga nenkqubo, uya kuthi usayine ifom yobhaliso, kwaye uya kuphendula nayiphi na imibuzo onayo malunga nenkqubo kunye nonyango lwakho ngenaliti ye-natalizumab.

Njengenxalenye yenkqubo ye-TOUCH, ugqirha wakho okanye unesi uya kukunika ikopi yesiKhokelo seyeza ngaphambi kokuba uqale unyango ngenaliti ye-natalizumab naphambi kokuba ufumane ukumnika. Funda olu lwazi ngenyameko ngalo lonke ixesha usamkela kwaye ubuze ugqirha okanye unesi ukuba unemibuzo. Ungandwendwela noLawulo lwezoKutya noLawulo lweziyobisi (FDA) iwebhusayithi (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) okanye iwebhusayithi yomenzi ukufumana isiKhokelo seMithi.

Kananjalo njengenxalenye yenkqubo ye-TOUCH, ugqirha wakho uyakufuna ukukubona qho kwiinyanga ezintathu ekuqaleni konyango lwakho kwaye ubuncinci rhoqo kwiinyanga ezi-6 ukuthatha isigqibo sokuba kufuneka uqhubeke usebenzisa i-natalizumab. Kuya kufuneka uphendule imibuzo ngaphambi kokuba ufumane ukumnika nganye ukuze uqiniseke ukuba i-natalizumab isakulungele.

Shayela ugqirha wakho ngokukhawuleza ukuba uhlakulela nayiphi na ingxaki entsha okanye eyingozi yonyango ngexesha lonyango lwakho, kunye neenyanga ezili-6 emva kwedosi yakho yokugqibela. Qiniseka ngokukodwa ukuba ubiza ugqirha wakho ukuba unazo naziphi na kwezi mpawu zilandelayo: ubuthathaka kwelinye icala lomzimba eliba mandundu ngokuhamba kwexesha; ukungxama kweengalo okanye imilenze; utshintsho kwindlela ocinga ngayo, inkumbulo, ukuhamba, ukulinganisela, intetho, ukubona kwamehlo, okanye amandla ahlala iintsuku ezininzi; intloko; ukuxhuzula; ukudideka; okanye utshintsho kubuntu.

Ukuba unyango lwakho ngenaliti ye-natalizumab lumisiwe ngenxa yokuba une-PML, unokuhlakulela enye imeko ebizwa ngokuba yi-immune reconstitution inflammatory syndrome (i-IRIS; ukudumba kunye nokuwohloka kweempawu ezinokubakho njengoko amajoni omzimba eqala ukusebenza kwakhona emva kokuba amayeza athile awuchaphazelayo eqalile. okanye uyeke), ngakumbi ukuba ufumana unyango lokususa i-natalizumab egazini lakho ngokukhawuleza. Ugqirha wakho uya kukujonga ngononophelo kwiimpawu ze-IRIS kwaye uya kuzinyanga ezi mpawu ukuba ziyenzeka.

Xelela bonke oogqirha abakunyangayo ukuba ufumana inaliti ye-natalizumab.

Thetha nogqirha wakho malunga nomngcipheko wokufumana inaliti ye-natalizumab.

I-Natalizumab isetyenziselwa ukuthintela iziqendu zeempawu kunye nokucothisa ukwanda kokukhubazeka kubantu abadala abathi baphinde baphinde baphume kwi-multiple sclerosis (MS; isifo apho imithambo-luvo ingasebenzi kakuhle kwaye abantu banokufumana ubuthathaka, ukuba ndindisholo, ukulahleka kwemisipha, kunye iingxaki ngombono, intetho, kunye nolawulo lwesinyi), kubandakanya:

• Isifo esizimeleyo kwiklinikhi (i-CIS; isiqhelo sesibonakaliso sokuqala se-nerve esihlala ubuncinci iiyure ezingama-24),
• Isifo esibuyisayo (isifo sesifo apho isifo sivela khona amaxesha ngamaxesha),
• isifo esikwesibini esiqhubekayo (kamva kwinqanaba lesifo kunye nokuqhubeka kokubi kweempawu.)

I-Natalizumab ikwasetyenziselwa ukunyanga kunye nokuthintela iziqendu zeempawu kubantu abadala abanesifo sikaCrohn (imeko apho umzimba uhlasela ubume bendlela yokugaya, ibangela iintlungu, urhudo, ukwehla kobunzima, kunye nefiva) abangakhange bancedwe ngabanye amayeza okanye ngubani ongakwaziyo ukuthatha amanye amayeza. I-Natalizumab ikudidi lwamayeza abizwa ngokuba ngamachiza omzimba omzimba. Isebenza ngokumisa iiseli ezithile zamajoni omzimba ekufikeleleni kwingqondo nakwintambo yomqolo okanye kumjelo wokugaya kunye nokwenza umonakalo.

I-Natalizumab iza njengesisombululo esixineneyo (ulwelo) sokuhlanjululwa kwaye sitofwe kancinci emthanjeni ngugqirha okanye ngumongikazi. Ihlala inikwa kube kanye kwiiveki ezi-4 kwiziko elibhalisiweyo lokumnika. Kuya kuthatha malunga neyure enye ukufumana idosi yakho yonke ye-natalizumab.

I-Natalizumab inokubangela ukusabela okunobungozi obunokubakho okunokwenzeka ukuba kwenzeke ngaphakathi kweeyure ezi-2 emva kokuqala kokufakwa, kodwa kunokwenzeka nangaliphi na ixesha kunyango lwakho. Kuya kufuneka uhlale kwiziko lokumnika i-1 iyure emva kokuba ukumiliselwa kwakho kugqityiwe. Ugqirha okanye umongikazi uya kukujonga ngeli xesha ukuze abone ukuba awunampendulo ibalulekileyo kunyango. Tshela ugqirha wakho okanye umongikazi ukuba ufumana naziphi na iimpawu ezingaqhelekanga ezinje ngemingxuma, irhashalala, ukurhawuzelela, ubunzima bokuginya okanye ukuphefumla, umkhuhlane, isiyezi, intloko ebuhlungu, iintlungu esifubeni, ukugungxula, isicaphucaphu, okanye ukugodola, ngakumbi ukuba zenzeka kwisithuba seeyure ezi-2 emva kokuqala ukumnika kwakho.

Ukuba ufumana inalza ye-natalizumab ukunyanga isifo sikaCrohn, iimpawu zakho kufuneka ziphuculwe kwiinyanga zokuqala ezimbalwa zonyango lwakho. Xelela ugqirha wakho ukuba iimpawu zakho azikaphucuki emva kweeveki ezili-12 zonyango. Ugqirha wakho angayeka ukunyanga ngenaliti ye-natalizumab.

I-Natalizumab inokunceda ukulawula iimpawu zakho kodwa ayizukuyinyanga imeko yakho. Gcina lonke usuku lokuqeshwa ukuze ufumane inaliti ye-natalizumab nokuba uziva uphilile.

Eli yeza linokumiselwa ezinye izinto; buza ugqirha wakho okanye usokhemesti ngolwazi oluthe kratya.

Ngaphambi kokufumana inaliti ye-natalizumab,

• xelela ugqirha wakho kunye nosokhemisti ukuba ngaba uxabisa i-natalizumab, nawaphi na amanye amayeza, okanye naziphi na izithako kwiinaliti ye-natalizumab. Buza ugqirha wakho okanye usokhemesti uluhlu lwezithako.
• xelela ugqirha wakho kunye nosokhemesti ukuba yeyiphi na amayeza kagqirha kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye neemveliso zamayeza owathathayo. Qiniseka ngokukhankanya amayeza adweliswe kwicandelo LESILUMKISO ESIBALULEKILEYO. Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
• xelela ugqirha wakho ukuba wakhe wafumana inaliti ye-natalizumab ngaphambili kwaye ukuba ukhe wakha wanazo naziphi na iimeko ezidweliswe kwicandelo LESILumkiso ESIBALULEKILEYO. Ngaphambi kokuba ufumane ukunyuswa kwe-natalizumab, xelela ugqirha wakho ukuba unefiva okanye naluphi na uhlobo losulelo, kubandakanya nosulelo oluhlala ixesha elide njenge-shingles (irhashalala enokuthi yenzeke amaxesha ngamaxesha kubantu abane-chickenpox ixesha eladlula).
• xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ukhulelwe ngelixa ufumana inaliti ye-natalizumab, biza ugqirha wakho.
• awunalo ugonyo ngaphandle kokuthetha nogqirha wakho.

Ngaphandle kokuba ugqirha wakho akuxelele ngenye indlela, qhubeka nokutya okuqhelekileyo.

Ukuba uphosa ixesha lokufumana i-natalizumab infusion, tsalela ugqirha ngokukhawuleza.

I-Natalizumab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

• intloko ebuhlungu
• ukudinwa kakhulu
• ukozela
• iintlungu ezidibeneyo okanye ukudumba
• iintlungu ezingalweni okanye emilenzeni
• umqolo obuhlungu
• ukudumba kweengalo, izandla, iinyawo, amaqatha okanye imilenze esezantsi
• izihlunu zemithambo
• isisu esibuhlungu
• urhudo
• isilungulela
• ukuqhina
• irhasi
• ubunzima okanye ukulahleka
• ukudakumba
• ukubila ebusuku
• ukuba sexesheni okubuhlungu, okungaqhelekanga, okanye okuphosiweyo (ixesha)
• ukudumba, ukuba bomvu, ukutshisa, okanye ukurhawuzelela kwilungu lobufazi
• ukukhutshwa okumhlophe kwilungu lobufazi
• ubunzima bokulawula ukuchama
• iintlungu zamazinyo
• izilonda zomlomo
• irhashalala
• isikhumba esomileyo
• ukurhawuzelela

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu zilandelayo okanye ezo zikhankanywe kwicandelo LESILUMKISO okanye ELIBALULEKILEYO, tsalela ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

• umqala obuhlungu, umkhuhlane, ukukhwehlela, ukugodola, umkhuhlane njengeempawu, isisu, isisu, urhudo, ukuchama rhoqo okanye okubuhlungu, isidingo sokuchama ngokukhawuleza, okanye ezinye iimpawu zosulelo.
• ubumthubi besikhumba okanye amehlo, isicaphucaphu, ukugabha, ukudinwa kakhulu, ukuphelelwa ngumdla wokutya, umchamo omnyama, iintlungu ezisekunene esiswini
• utshintsho lombono, ubomvu wamehlo, okanye iintlungu
• ukopha okungaqhelekanga okanye ukugruzuka
• amancinci, arawndi, abomvu okanye amfusa-umbala amabala kulusu
• ukuphuma kwegazi okunzima

Inaliti yeNatalizumab inokubangela ezinye iziphumo ebezingalindelekanga. Biza ugqirha wakho ukuba unayo nayiphi na ingxaki engaqhelekanga ngelixa ufumana eliyeza.

Ukuba uhlangabezana neziphumo ebezingalindelekanga ezimandundu, wena okanye ugqirha wakho ungathumela ingxelo kwiNkqubo yoKutya kunye nezoLawulo (i-FDA) yeMedWatch yeNkqubo yokuNgxelo ngezeMeko eziGwenxa kwi-Intanethi (http://www.fda.gov/Safety/MedWatch) okanye ngomnxeba ( 1-800-332-1088).

Kwimeko yokugqithisa, fowunela umnxeba wolawulo lwetyhefu kwi-1-800-222-1222. Ulwazi lukwafumaneka kwi-Intanethi kwi-https: //www.poisonhelp.org/help. Ukuba ixhoba liye lawa, laxhuzula, linengxaki yokuphefumla, okanye alikwazi ukuvuswa, ngoko nangoko lifowunele iinkonzo zongxamiseko ngo-911.

Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho unokuyalela iimvavanyo ezithile zebhu ukujonga impendulo yomzimba wakho kwinaliti ye-natalizumab.

Kubalulekile ukuba ugcine uluhlu olubhaliweyo lwawo onke amayeza owasebenzisayo amayeza owasebenzisayo, kunye nezinye iimveliso ezinjengeevithamini, iiminerali, okanye ezinye izongezo zokutya. Kuya kufuneka uze nolu luhlu qho xa undwendwela ugqirha okanye ungeniswe esibhedlele. Kukwabalulekile ulwazi ukuba uphathe nawe xa kukho imeko kaxakeka.

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