Inaliti ye-Brexucabtagene Autoleucel

-Delile

• Ngaphambi kokuthola i-brexucabtagene autoleucel,
• I-Brexucabtagene autoleucel ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezibalwe esigabeni ESIBALULEKILE SESEXWAYISO, shayela udokotela wakho ngokushesha:

Umjovo we-Brexucabtagene autoleucel ungadala ukusabela okubi noma okusongela impilo okubizwa nge-cytokine release syndrome (CRS). Udokotela noma umhlengikazi uzokuqapha ngokucophelela ngesikhathi sokumnika kwakho futhi okungenani amasonto ama-4 ngemuva kwalokho. Tshela udokotela wakho uma unesifo sokuvuvukala noma uma une noma ucabanga ukuthi ungaba nanoma yiluphi uhlobo lokutheleleka manje. Uzonikezwa imithi imizuzu engama-30 kuye kwengama-60 ngaphambi kokumiliselwa kwakho ukusiza ukuvimbela ukusabela ku-brexucabtagene autoleucel. Uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi sokumenyezelwa nangemuva kokumfakelwa, tshela udokotela wakho ngokushesha: umkhuhlane, ukugodola, ukushaya kwenhliziyo okusheshayo noma okungajwayelekile, ubuhlungu bemisipha, ukuqhaqhazela, uhudo, ukukhathala, ubuthakathaka, ukuphefumula kanzima, ukuphefumula okuncane, ukukhwehlela, ukudideka, isicanucanu, ukuhlanza, isiyezi, noma ikhanda elikhanyayo.

Umjovo we-Brexucabtagene autoleucel ungadala ukusabela okunamandla noma okusongela ukuphila kohlelo oluphakathi lwezinzwa. Lokhu kusabela kungenzeka ngemuva kokwelashwa nge-brexucabtagene autoleucel. Tshela udokotela wakho uma uke wahlaselwa noma wahlaselwa isifo sohlangothi, noma ulahlekelwe yimemori. Uma uhlangabezana nanoma yiziphi kulezi zimpawu ezilandelayo, tshela udokotela wakho ngokushesha: ikhanda, isiyezi, ubunzima bokulala noma ukulala, ukuphumula, ukudideka, ukukhathazeka, ukuthuthumela okungalawuleki kwengxenye ethile yomzimba, ukulahlekelwa ukwazi, ukuphazamiseka, ukuquleka, ukulahlekelwa ibhalansi, noma ubunzima bokukhuluma.

Umjovo weBrexucabtagene autoleucel utholakala kuphela ngohlelo olukhethekile lokusabalalisa olukhawulelwe ngenxa yezingozi zeCRS kanye nobuthi bezinzwa. Ungathola kuphela umuthi kudokotela nasendaweni yokunakekelwa kwezempilo ebamba iqhaza kulolu hlelo. Buza udokotela wakho uma unemibuzo ngalolu hlelo.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho uzo-oda izivivinyo ezithile ukuze ahlole impendulo yomzimba wakho ku-brexucabtagene autoleucel.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa nge-brexucabtagene autoleucel futhi isikhathi ngasinye lapho ugcwalisa khona incwadi kadokotela. 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) noma iwebhusayithi yomkhiqizi ukuthola i-Medication Guide.

I-Brexucabtagene autoleucel isetshenziselwa ukwelapha i-mantle cell lymphoma (umdlavuza okhula ngokushesha oqala kumaseli amasosha omzimba) kubantu abadala ababuyile noma abangaphenduli kwezinye izindlela zokwelashwa. Umjovo weBrexucabtagene autoleucel usesigabeni semithi ebizwa nge-autologous cell immunotherapy, uhlobo lomuthi olungiselelwe kusetshenziswa amaseli avela egazini lesiguli uqobo. Isebenza ngokubangela amasosha omzimba omzimba (iqembu lamaseli, izicubu, nezitho ezivikela umzimba ekuhlaselweni amagciwane, amagciwane, amangqamuzana omdlavuza, nezinye izinto ezibangela izifo) ukulwa namaseli omdlavuza.

IBrexucabtagene autoleucel iza njengokumiswa (uketshezi) okuzofakwa ngomjovo (emthanjeni) ngudokotela noma unesi ehhovisi likadokotela noma esikhungweni sokumnika. Imvamisa inikezwa isikhathi esifinyelela kumizuzu engama-30 njengomthamo wesikhathi esisodwa. Ngaphambi kokuthola umthamo wakho we-brexucabtagene autoleucel, udokotela wakho noma umhlengikazi uzokuphathisa eminye imithi yokwelapha ngamakhemikhali ukulungiselela umzimba wakho i-brexucabtagene autoleucel.

Ngaphambi kokuba unikezwe umjovo wakho we-brexucabtagene autoleucel injection, kuzothathwa isampula lamangqamuzana akho amhlophe egazi esikhungweni sokuqoqa amaseli kusetshenziswa inqubo ebizwa nge-leukapheresis (inqubo esusa amangqamuzana amhlophe egazi emzimbeni). Ngoba lo muthi wenziwa ngamaseli akho, kufanele unikezwe wena kuphela. Kubalulekile ukuthi ufike ngesikhathi futhi ungaphuthelwa ukuqokwa kwama (cell) okuhleliwe noma ukuthola umuthi wakho wokwelashwa. Kufanele uhlele ukuhlala eduze nalapho uthola khona ukwelashwa kwakho kwe-brexucabtagene autoleucel okungenani amasonto ama-4 ngemuva komthamo wakho. Umhlinzeki wakho wezokunakekelwa kwempilo uzohlola ukuthi ngabe ukwelashwa kwakho kuyasebenza yini futhi akubheke nganoma yimiphi imiphumela emibi engaba khona. Khuluma nodokotela wakho mayelana nokuthi ungayilungiselela kanjani i-leukapheresis nokuthi yini ongayilindela ngesikhathi nangemva kwenqubo.

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

Ngaphambi kokuthola i-brexucabtagene autoleucel,

• Tshela udokotela kanye nosokhemisi wakho uma unegciwane ku-brexucabtagene autoleucel, noma imuphi omunye umuthi, noma iziphi izithako ze-brexucabtagene autoleucel. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi eminye imishanguzo kadokotela neyokungabhalisi, amavithamini, izithasiselo zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• utshele udokotela wakho uma uke waba nesifo samaphaphu, sezinso, senhliziyo, noma sesibindi.
• tshela udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uzodinga ukuhlolwa kokukhulelwa ngaphambi kokuqala i-brexucabtagene autoleucel. Uma ukhulelwa ngenkathi uthola i-brexucabtagene autoleucel, shayela udokotela wakho ngokushesha.
• kufanele wazi ukuthi umjovo we-brexucabtagene autoleucel ungakwenza ukozele futhi ubangele ukudideka, ubuthakathaka, isiyezi, ukuqumba nezinkinga zokuhlanganisa. Ungashayeli imoto noma usebenzise imishini okungenani amasonto ayi-8 ngemuva komthamo wakho we-brexucabtagene autoleucel.
• unganikeli ngegazi, izitho, izicubu, noma amaseli ukufakelwa kabusha ngemuva kokuthola umjovo wakho we-brexucabtagene autoleucel.
• thintana nodokotela wakho ukuze ubone uma ngabe udinga ukuthola noma yimiphi imigomo. Ungabi nayo imigomo ngaphandle kokukhuluma nodokotela wakho okungenani amasonto ayisithupha ngaphambi kokuqala i-chemotherapy, ngesikhathi sokwelashwa kwe-brexucabtagene autoleucel, futhi kuze kube yilapho udokotela wakho ekutshela ukuthi amasosha omzimba wakho aseluleme.

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

Uma uphuthelwa isikhathi sokuqokwa kwamaseli akho, kufanele ushayele udokotela wakho kanye nendawo yokuqoqa khona manjalo. Uma uphuthelwa ukuqokwa ukuze uthole umthamo wakho we-brexucabtagene autoleucel, kufanele ushayele udokotela wakho khona manjalo.

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

• ukuqunjelwa
• ubuhlungu besisu
• ukulahlekelwa isifiso sokudla
• ubuhlungu bomlomo
• ubunzima bokugwinya
• ukuqubuka

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezibalwe esigabeni ESIBALULEKILE SESEXWAYISO, shayela udokotela wakho ngokushesha:

• isikhumba esiphaphathekile noma ukuphefumula okuncane
• umkhuhlane, umphimbo obuhlungu, amakhaza, noma ezinye izimpawu zokutheleleka
• kunciphise imvamisa yokuchama noma inani
• ukuba ndikindiki, ubuhlungu, ukudikiza, noma umuzwa ovuthayo ezinyaweni noma ezandleni

Umjovo we-Brexucabtagene autoleucel ungakhuphula ubungozi bokuthola umdlavuza othile. Khuluma nodokotela wakho ngezingozi zokuthola lo muthi.

Umjovo weBrexucabtagene autoleucel 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).

Gcina konke ukubonana nodokotela wakho, isikhungo sokuqoqwa kwamaseli, kanye nelabhorethri. Udokotela wakho anga-oda izivivinyo ezithile zelebhu ngaphambi, ngesikhathi, nangemva kokwelashwa kwakho ukuze ahlole impendulo yomzimba wakho kumjovo we-brexucabtagene autoleucel.

Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana ne-brexucabtagene autoleucel.

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.

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