Umjovo we-Idecabtagene Vicleucel

-Delile

• Ngaphambi kokuthola umjovo we-idecabtagene vicleucel,
• Idecabtagene vicleucel 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 SEXWAYISO, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

Umjovo we-Idecabtagene vicleucel 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-idecabtagene vicleucel. 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-Idecabtagene vicleucel ungadala ukusabela okunzima noma okusongela ukuphila kohlelo oluphakathi lwezinzwa. Lokhu kusabela kungenzeka ngemuva kokwelashwa nge-idecabtagene vicleucel. 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 we-Idecabtagene vicleucel ungadala ukwehla okukhulu enanini lezinhlobo ezithile zamaseli egazi egazini lakho. Lokhu kungadala izimpawu ezithile futhi kungakhuphula ubungozi bokuthi uzoba nokutheleleka okungathi sína noma ukopha. Uma uhlangabezana nalezi zimpawu ezilandelayo ngemuva kokwelashwa kwakho, tshela udokotela wakho ngokushesha: umkhuhlane, ukuzwa ukhathele, noma ukulimazeka noma ukopha.

Idecabtagene vicleucel itholakala kuphela ngohlelo olukhethekile lokusabalalisa olukhawulelwe. Uhlelo lwe-Abecma REMS (iRisk Evaluation and Mitigation Strategy) selusungulwe ngenxa yezingozi zeCRS, central system nervous, kanye nezinkinga zamangqamuzana egazi. 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-idecabtagene vicleucel 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) noma iwebhusayithi yomkhiqizi ukuthola i-Medication Guide.

Umjovo we-Idecabtagene vicleucel usetshenziselwa ukwelapha izinhlobo ezithile ze-myeloma eminingi (uhlobo lomdlavuza womnkantsha wethambo) kubantu abadala abanomdlavuza obuyile noma ongaphenduli okungenani kwezinye izindlela zokwelashwa ezine. Umjovo we-Idecabtagene vicleucel usesigabeni semithi ebizwa nge-autologous cell 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.

Umjovo we-Idecabtagene vicleucel uza njengokumiswa (uketshezi) okuzofakwa ngomjovo (emthanjeni) ngudokotela noma umhlengikazi osehhovisi likadokotela noma esikhungweni sokumnika. Imvamisa inikezwa isikhathi esiphelele semizuzu engama-30 njengomthamo wesikhathi esisodwa. Ngaphambi kokuthola umthamo wakho we-idecabtagene vicleucel, udokotela noma umhlengikazi wakho uzokuphathisa eminye imithi yokwelapha ngamakhemikhali ukulungiselela umzimba wakho i-idecabtagene vicleucel.

Ngaphambi kokuba unikezwe umjovo wakho we-idecabtagene vicleucel injection, kuzothathwa isampula lamaseli akho amhlophe 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 ngaphakathi kwamahora ama-2 wendawo lapho uthole khona ukwelashwa kwe-idecabtagene vicleucel 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-idecabtagene vicleucel,

• Tshela udokotela wakho kanye nosokhemisi uma une-aleji ye-idecabtagene vicleucel, noma imiphi eminye imishanguzo, i-dimethyl sulfoxide (DMSO), noma ezinye izithako zomjovo we-idecabtagene vicleucel. 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.
• tshela udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uzodinga ukuhlolwa kokukhulelwa ngaphambi kokuqala i-idecabtagene vicleucel. Uma ukhulelwa ngenkathi uthola i-idecabtagene vicleucel, shayela udokotela wakho ngokushesha. Idecabtagene vicleucel ingalimaza umbungu.
• kufanele wazi ukuthi umjovo we-idecabtagene vicleucel ungakwenza ukozele futhi ubangele ukudideka, ubuthakathaka, isiyezi, ukuqumba nezinkinga zokuhlanganisa. Ungashayeli imoto noma usebenzise imishini okungenani amasonto ayi-8 ngemuva komthamo wakho we-idecabtagene vicleucel.
• unganikeli ngegazi, izitho, izicubu, noma amaseli ukufakelwa kabusha ngemuva kokuthola umjovo wakho we-idecabtagene vicleucel.
• 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-idecabtagene vicleucel, futhi kuze kube yilapho udokotela wakho ekutshela ukuthi amasosha omzimba wakho aseluleme.

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

Idecabtagene vicleucel ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ukuqunjelwa
• ukuncipha komzimba
• ukulahlekelwa isifiso sokudla
• ubuhlungu bomlomo
• umlomo owomile
• amehlo omile

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

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

I-Idecabtagene vicleucel ingakhuphula ubungozi bokuthola umdlavuza othile. Khuluma nodokotela wakho ngezingozi zokuthola lo muthi.

Idecabtagene vicleucel ingadala 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 angalawula izivivinyo ezithile zelebhu ngaphambi, ngesikhathi, nangemva kokwelashwa kwakho ukuze ahlole impendulo yomzimba wakho kumjovo we-idecabtagene vicleucel.

Ngaphambi kokwenza noma yiluphi uvivinyo lwelabhoratri, tshela udokotela wakho kanye nabasebenzi belebhuthi ukuthi uthola i-idecabtagene vicleucel. Lo muthi ungathinta imiphumela yokuhlolwa okuthile kwelebhu.

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

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.

• Abecma^®