Inaliti ye-Tisagenlecleucel

-Delile

• Ngaphambi kokuthola umjovo we-tisagenlecleucel,
• Umjovo we-Tisagenlecleucel ungadala 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 SEXWAYISO, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

Umjovo we-Tisagenlecleucel ungadala ukusabela okungathi sína noma okusongela ukuphila 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 kokufakwa kwakho ukusiza ukuvimbela ukusabela ku-tisagenlecleucel. Uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi sokumenyezelwa nangemva kokuminyelwa kwakho, tshela udokotela wakho ngokushesha: umkhuhlane, ukugodola, ukuqhaqhazela, ukukhwehlela, ukungathandi ukudla, isifo sohudo, ubuhlungu bemisipha noma obuhlangene, ukukhathala, ukuphefumula kanzima, ukuphefumula okuncane, ukudideka, isicanucanu , ukuhlanza, isiyezi, noma ikhanda elikhanyayo.

Umjovo we-Tisagenlecleucel ungadala ukusabela okunamandla noma okusongela impilo. Uma uhlangabezana nalezi zimpawu ezilandelayo, tshela udokotela wakho ngokushesha: ikhanda, ukungahlaliseki, ukudideka, ukukhathazeka, ubunzima bokulala noma ukulala, ukuzamazama okungalawuleki kwengxenye yomzimba, ukulahlekelwa ukwazi, ukudideka, ukuphazamiseka, ukuxhuzula, ubuhlungu noma ukuba ndikindiki engalweni noma emlenzeni, ukulahlekelwa ibhalansi, ukuqonda ubunzima, noma ukukhuluma kanzima.

Umjovo we-Tisagenlecleucel utholakala kuphela ngohlelo olukhethekile lokusabalalisa olukhawulelwe. Uhlelo olubizwa ngeKymriah REMS (Risk Evaluation and Mitigation Strategy) selusunguliwe ngenxa yezingozi zeCRS kanye nobuthi bezinzwa. Ungathola kuphela umuthi kudokotela nasendaweni yokunakekelwa kwezempilo ebamba iqhaza kulolu hlelo.Buza udokotela wakho uma unemibuzo ngalolu hlelo.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa nge tisagenlecleucel. 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.

Umjovo we-Tisagenlecleucel usetshenziselwa ukwelapha i-leukemia ethile ye-lymphoblastic (ALL; futhi ibizwa nangokuthi i-acute lymphoblastic leukemia kanye ne-acute lymphatic leukemia; uhlobo lomdlavuza oqala kumaseli amhlophe egazi) kubantu abaneminyaka engama-25 ubudala noma ngaphansi obuyile noma ongaphenduli ezinye izindlela zokwelashwa. Ibuye isetshenziselwe ukwelapha uhlobo oluthile lwe-non-Hodgkin's lymphoma (uhlobo lomdlavuza oluqala ngohlobo lwamaseli amhlophe egazi ngokuvamile alwa nokutheleleka) kubantu abadala asebebuyile noma abangaphenduli ngemuva kokwelashwa okungenani ngeminye imithi emibili. Umjovo weTisagenlecleucel usesigabeni semithi ebizwa nge-autologous cellular 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.

Umjovo we-Tisagenlecleucel uza njengokumiswa (uketshezi) okuzofakwa ngaphakathi (emthanjeni) ngudokotela noma umhlengikazi osehhovisi likadokotela noma esikhungweni sokumnika. Imvamisa inikezwa isikhathi esifinyelela kumizuzu engama-60 njengomthamo wesikhathi esisodwa. Ngaphambi kokuthola umthamo wakho we-tisagenlecleucel, udokotela noma umhlengikazi wakho uzokuphathisa eminye imithi yokwelapha ngamakhemikhali ukulungiselela umzimba wakho i-tisagenlecleucel.

Cishe emasontweni amathathu kuye kwayi-4 ngaphambi kokuba kunikezwe umjovo wakho we-tisagenlecleucel, kuzothathwa isampula lamaseli akho amhlophe esikhungweni sokuqoqa amaseli kusetshenziswa inqubo ebizwa nge-leukapheresis (inqubo esusa amangqamuzana amhlophe egazi emzimbeni). Le nqubo izothatha cishe amahora amathathu kuya kwayisithupha futhi ingadinga ukuphindwa. 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 ngaphakathi kwamahora ama-2 wendawo lapho uthole khona ukwelashwa kwakho kwe-tisagenlecleucel 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 umjovo we-tisagenlecleucel,

• Tshela udokotela kanye nosokhemisi wakho uma uxabana ne-tisagenlecleucel, noma imiphi eminye imithi, i-dimethyl sulfoxide (DMSO), i-dextran 40, noma ezinye izithako zomjovo we-tisagenlecleucel. 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. Qiniseka ukuthi usho noma yikuphi okulandelayo: i-steroids efana ne-dexamethasone, i-methylprednisolone (i-Medrol), i-prednisolone, ne-prednisone (i-Rayos). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• Tshela udokotela wakho uma ngabe uke waphendula ngokwelashwa okwedlule kwamakhemikhali njengezinkinga zokuphefumula noma ukushaya kwenhliziyo okungajwayelekile. Futhi, tshela udokotela wakho uma uke waba nesifo samaphaphu, sezinso, senhliziyo, noma sesibindi.
• utshele udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uzodinga ukuhlolwa kokukhulelwa ngaphambi kokuqala ukwelashwa kwe-tisagenlecleucel. Uma ukhulelwa ngenkathi uthola umjovo we-tisagenlecleucel, shayela udokotela wakho ngokushesha. Umjovo we-Tisagenlecleucel ungadala ukulimala kwengane.
• kufanele wazi ukuthi umjovo we-tisagenlecleucel ungakwenza ukozele futhi ubangele ukudideka, ubuthakathaka, isiyezi nokuquleka. Ungashayeli imoto noma usebenzise imishini okungenani amasonto ayi-8 ngemuva komthamo wakho we-tisagenlecleucel.
• unganikeli ngegazi, izitho, izicubu, noma amaseli ukufakelwa kabusha ngemuva kokuthola umjovo we-tisagenlecleucel.
• thintana nodokotela wakho ukuze ubone uma ngabe udinga ukuthola noma yimiphi imigomo. Ungabi nayo imigomo ngaphandle kokukhuluma nodokotela wakho okungenani amasonto ama-2 ngaphambi kokuqala i-chemotherapy, ngesikhathi sokwelashwa kwakho kwe-tisagenlecleucel, 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-tisagenlecleucel, kufanele ushayele udokotela wakho khona manjalo.

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

• ukuqunjelwa
• ubuhlungu besisu
• ukuhlungu obusemhlane

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

• ukopha okungajwayelekile noma ukulinyazwa
• igazi emchameni
• kunciphise imvamisa yokuchama noma inani
• ukuvuvukala kwamehlo, ubuso, izindebe, ulimi, umphimbo, izingalo, izandla, izinyawo, amaqakala noma imilenze engezansi
• ubunzima bokugwinya
• ukuqubuka
• isifuba
• ukulunywa

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

Umjovo we-Tisagenlecleucel 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-tisagenlecleucel.

Ngaphambi kokwenza noma yiluphi uvivinyo lwelabhoratri, tshela udokotela wakho kanye nabasebenzi be-laboratory ukuthi uthola umjovo we-tisagenlecleucel. Lo muthi ungathinta imiphumela yokuhlolwa okuthile kwelebhu.

Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana nomjovo we-tisagenlecleucel.

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.

• UKymriah^®