Umjovo we-Lisocabtagene Maraleucel

-Delile

• Ngaphambi kokuthola i-lisocabtagene maraleucel,
• ILisocabtagene maraleucel 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 weLisocabtagene maraleucel ungadala ukusabela okungathi sína 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 kuya kwengama-60 ngaphambi kokufakwa kwakho ukusiza ukuvimbela ukusabela ku-lisocabtagene maraleucel. 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 weLisocabtagene maraleucel ungadala ukusabela okunzima noma okusongela ukuphila kohlelo oluphakathi lwezinzwa. Lokhu kusabela kungenzeka ngemuva kokwelashwa nge-lisocabtagene maraleucel. 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-Lisocabtagene maraleucel utholakala kuphela ngohlelo olukhethekile lokusabalalisa olukhawulelwe. Uhlelo lweBreyanzi 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-lisocabtagene maraleucel 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.

ILisocabtagene maraleucel isetshenziselwa ukwelapha izinhlobo ezithile ze-B-cell lymphoma enkulu (uhlobo lomdlavuza oluqala kumaseli amhlophe egazi) kubantu abadala abanomdlavuza obuyile noma ongaphenduli kokunye okungenani ukwelashwa okubili. ILisocabtagene maraleucel isekilasini lemithi 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.

ILisocabtagene maraleuceliza njengokumiswa (uketshezi) ukujova ngomjovo (emthanjeni) ngudokotela noma umhlengikazi ehhovisi likadokotela noma esikhungweni sokumnika. Imvamisa inikezwa njengokungeniswa okumbili esikhathini esiphelele semizuzu engama-30 njengomthamo wesikhathi esisodwa. Ngaphambi kokuthola umthamo wakho we-lisocabtagene maraleucel, udokotela noma umhlengikazi wakho uzokuphathisa eminye imithi yokwelapha ngamakhemikhali ukulungiselela umzimba wakho i-lisocabtagene maraleucel.

Ngaphambi kokuba kunikezwe umjovo wakho we-lisocabtagene maraleucel 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 eduze nalapho uthole khona ukwelashwa kwakho kwe-lisocabtagene maraleucel 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-lisocabtagene maraleucel,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-lisocabtagene maraleucel, noma imuphi omunye umuthi, noma iziphi izithako ezise-lisocabtagene maraleucel. 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 negciwane le-hepatitis B noma isifo sesibindi.
• tshela udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uzodinga ukuhlolwa kokukhulelwa ngaphambi kokuqala i-lisocabtagene maraleucel. Uma ukhulelwa ngenkathi uthola i-lisocabtagene maraleucel, shayela udokotela wakho ngokushesha.
• kufanele wazi ukuthi umjovo we-lisocabtagene maraleucel ungakwenza ukozele futhi ubangele ukudideka, ubuthakathaka, isiyezi, ukuqumba nezinkinga zokuhlanganisa. Ungashayeli imoto noma usebenzise imishini okungenani amasonto ayisishiyagalombili ngemuva kwesilinganiso sakho se-lisocabtagene maraleucel.
• unganikeli ngegazi, izitho, izicubu, noma amaseli ukufakelwa kabusha ngemuva kokuthola umjovo wakho we-lisocabtagene maraleucel.
• 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-lisocabtagene maraleucel, 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-lisocabtagene maraleucel, kufanele ushayele udokotela wakho khona manjalo.

ILisocabtagene maraleucel ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ukuqunjelwa
• ubuhlungu besisu
• ukulahlekelwa isifiso sokudla
• ukuqubuka
• ukuba ndikindiki, ubuhlungu, ukudikiza, noma umuzwa ovuthayo ezinyaweni noma ezandleni

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

• ngizizwe ngikhathele
• ukulinyazwa noma ukopha
• umkhuhlane, umphimbo obuhlungu, amakhaza, noma ezinye izimpawu zokutheleleka
• ukudideka
• ukushaya kwenhliziyo okusheshayo noma okungajwayelekile

ILisocabtagene maraleucel ingakhuphula ubungozi bokuthola umdlavuza othile. Khuluma nodokotela wakho ngezingozi zokuthola lo muthi.

ILisocabtagene maraleucel 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-lisocabtagene maraleucel.

Ngaphambi kokwenza noma yiluphi uvivinyo lwelabhoratri, tshela udokotela wakho kanye nabasebenzi be-laboratory ukuthi uthola i-lisocabtagene maraleucel.

Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana ne-lisocabtagene maraleucel.

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.

• Breyanzi^®