Inaliti yeTisagenlecleucel

Umxholo

• Phambi kokuba ufumane isitofu se-tisagenlecleucel,
• Inaliti yeTisagenlecleucel inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:
• Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko okanye ufumane unyango olungxamisekileyo:

Inaliti ye-Tisagenlecleucel inokubangela ukusabela okunobungozi okanye okusongela ubomi okubizwa ngokuba yi-cytokine release syndrome (CRS). Ugqirha okanye umongikazi uya kukujonga ngononophelo ngexesha lokufakwa kwakho kunye ubuncinci iiveki ezi-4 emva koko. Tshela ugqirha wakho ukuba unesifo esivuthayo okanye ukuba unayo okanye ucinga ukuba unalo naluphi na uhlobo losulelo ngoku. Uya kunikwa amayeza imizuzu engama-30 ukuya kwengama-60 ngaphambi kokufakwa kwakho ukunceda ukuthintela iimpendulo kwi-tisagenlecleucel. Ukuba ufumana naziphi na kwezi mpawu zilandelayo ngexesha nasemva kokufakwa, xelela ugqirha ngoko nangoko: umkhuhlane, ukugodola, ukungcangcazela, ukukhohlela, ukuphelelwa ngumdla, urhudo, izihlunu okanye iintlungu ezidibeneyo, ukudinwa, ukuphefumla nzima, ukuphefumla kancinci, ukudideka, isicaphucaphu , ukugabha, isiyezi, okanye iintloko ezingakhanyi.

Inaliti ye-Tisagenlecleucel inokubangela ukusabela okubukhali okanye okusongela ubomi. Ukuba unazo naziphi na kwezi mpawu zilandelayo, xelela ugqirha ngoko nangoko: intloko ebuhlungu, ukungazinzi, ukudideka, ixhala, ubunzima bokulala okanye ukulala, ukungcangcazela okungalawulekiyo komzimba, ukungabikho kwengqondo, ukudideka, ukuphazamiseka, ukuxhuzula, iintlungu okanye ukuba ndindisholo ngengalo okanye emlenzeni, ukuphulukana nokulingana, ukuqonda ubunzima, okanye ukuthetha nzima.

Inaliti yeTisagenlecleucel ifumaneka kuphela kwinkqubo ekhethekileyo yokuhambisa. Inkqubo ebizwa ngokuba yiKymriah REMS (uVavanyo loMngcipheko kunye neQhinga lokuNciphisa) isekiwe ngenxa yomngcipheko weCRS kunye neetyhefu ze-neurological. Unokufumana amayeza kugqirha nakwiziko lokhathalelo lwempilo oluthatha inxaxheba kule nkqubo.Buza ugqirha wakho ukuba unemibuzo malunga nale nkqubo.

Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwesigulana lomenzi (Isikhokelo seyeza) xa uqala unyango nge tisagenlecleucel. Funda ulwazi ngononophelo kwaye ubuze ugqirha okanye usokhemesti ukuba unayo nayiphi na imibuzo. Ungandwendwela noLawulo lwezoKutya noLawulo lweziyobisi (FDA) iwebhusayithi (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) okanye iwebhusayithi yomenzi ukufumana isiKhokelo seMithi.

Inaliti ye-Tisagenlecleucel isetyenziselwa ukunyanga i-leukemia ethile ye-lymphoblastic (YONKE; ikwabizwa ngokuba yi-acute lymphoblastic leukemia kunye ne-acute lymphatic leukemia; uhlobo lomhlaza oqala kwiiseli ezimhlophe zegazi) kubantu abaneminyaka engama-25 ubudala okanye omncinci obuyileyo okanye ongaphenduliyo ezinye iindlela zonyango. Isetyenziselwa ukunyanga uhlobo oluthile lwe-non-Hodgkin's lymphoma (uhlobo lomhlaza oluqala kuhlobo lweeseli ezimhlophe zegazi ezihlala zilwa nosulelo) kubantu abadala ababuyileyo okanye abangaphenduliyo emva konyango ubuncinci ngamanye amayeza. Inaliti yeTisagenlecleucel ikudidi lwamayeza abizwa ngokuba yi-autologous cellular immunotherapy, uhlobo lonyango olulungiselelwe ukusebenzisa iiseli ezivela kwigazi lesigulana. Isebenza ngokubangela amajoni omzimba (iqela leeseli, izicwili, kunye namalungu akhusela umzimba ekuhlaselweni ziintsholongwane, iintsholongwane, iiseli zomhlaza, kunye nezinye izinto ezibangela izifo) ukuba zilwe neeseli zomhlaza.

Inaliti yeTisagenlecleucel iza njengokumiswa (ulwelo) ukuze kutofelwe ngaphakathi (emthanjeni) ngugqirha okanye ngumongikazi kwiofisi kagqirha okanye kwiziko lokumnika. Ihlala inikwa ngaphezulu kwesithuba semizuzu engama-60 njengedosi yexesha elinye. Phambi kokuba ufumane idosi yakho ye-tisagenlecleucel, ugqirha wakho okanye umongikazi uya kukunika amanye amayeza e-chemotherapy ukulungiselela umzimba wakho ukuze ufumane i-tisagenlecleucel.

Malunga neeveki ezi-3 ukuya kwezi-4 ngaphambi kokuba kunikwe inaliti yakho ye-tisagenlecleucel, isampuli yeeseli zakho ezimhlophe zegazi ziya kuthathwa kwiziko lokuqokelela iiseli kusetyenziswa inkqubo ebizwa ngokuba yi-leukapheresis (inkqubo esusa iiseli ezimhlophe zegazi emzimbeni). Le nkqubo iya kuthatha malunga neeyure ezi-3 ukuya kwezi-6 kwaye inokufuna ukuphindwa. Ngenxa yokuba eli yeza lenziwa kwiiseli zakho, kufuneka unikwe wena kuphela. Kubalulekile ukuba ufike ngexesha kwaye ungaphoswa kukuqokelelwa (okanye) kokuqokelelwa kweeselfowuni okanye ukufumana idosi yonyango. Kuya kufuneka ucwangcise ukuhlala ngaphakathi kwiiyure ezi-2 zendawo apho ufumene khona unyango lwakho lwe-tisagenlecleucel okungenani iiveki ezi-4 emva kwedosi yakho. Umboneleli wakho wezononophelo lwempilo uya kujonga ukuba unyango lwakho luyasebenza na kwaye akubeke esweni naziphi na iziphumo ebezingalindelekanga ezinokubakho. Thetha nogqirha wakho malunga nendlela yokulungiselela i-leukapheresis kunye nento onokuyilindela ngexesha nasemva kwenkqubo.

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

Phambi kokuba ufumane isitofu se-tisagenlecleucel,

• xelela ugqirha wakho kunye nosokhemesti ukuba ngaba uxabana no-tisagenlecleucel, nawaphi na amanye amayeza, i-dimethyl sulfoxide (DMSO), i-dextran 40, okanye nasiphi na esinye isithako kwisitofu se-tisagenlecleucel. Buza usokhemesti wakho okanye ujonge isiKhokelo seyeza ukuze ufumane uluhlu lwezithako.
• xelela ugqirha wakho kunye nosokhemesti ukuba loluphi olunye amayeza amiselweyo kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye nemveliso yamayeza owathathayo okanye oceba ukuyithatha. Qiniseka ukuba ukhankanya nayiphi na kwezi zinto zilandelayo: ii-steroids ezinje nge-dexamethasone, methylprednisolone (Medrol), prednisolone, kunye ne-prednisone (iRayos). Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
• xelela ugqirha wakho ukuba wakhe wanokuphendula kunyango lwe-chemotherapy lwangaphambili olunjengeengxaki zokuphefumla okanye ukubetha kwentliziyo okungaqhelekanga. Kwakhona xelela ugqirha wakho ukuba unomphunga, izintso, intliziyo, okanye isifo sesibindi.
• xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Uya kudinga kuvavanyo lokukhulelwa ngaphambi kokuba uqalise unyango lwe-tisagenlecleucel. Ukuba uyakhulelwa ngelixa ufumana isitofu se-tisagenlecleucel, tsalela umnxeba kwangoko. Inaliti yeTisagenlecleucel inokubangela ukwenzakala komntwana.
• Kuya kufuneka uyazi ukuba isitofu se-tisagenlecleucel sinokukwenza uzele kwaye ubangele ukudideka, ubuthathaka, isiyezi kunye nokuxhuzula. Musa ukuqhuba imoto okanye usebenzise oomatshini ubuncinci iiveki ezisi-8 emva kwedosi yakho ye-tisagenlecleucel.
• musa ukunikela ngegazi, amalungu, izicwili, okanye iiseli zokufakelwa emva kokuba ufumene inaliti ye-tisagenlecleucel.
• jongana nogqirha wakho ukubona ukuba ufuna ukufumana naluphi na ugonyo. Awunalo naluphi na ugonyo ngaphandle kokuthetha nogqirha wakho ubuncinci iiveki ezi-2 ngaphambi kokuqala ichemotherapy, ngexesha lonyango lwakho lwe-tisagenlecleucel, de ugqirha akuxelele ukuba amajoni akho omzimba aphile.

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

Ukuba uphosa ixesha lokuqokelela iiseli zakho, kuya kufuneka ubize ugqirha wakho kunye neziko lokuqokelela kwangoko. Ukuba uphosa ixesha lokuqeshwa ukuze ufumane idosi yakho ye-tisagenlecleucel, kuya kufuneka ubize ugqirha ngoko nangoko.

Inaliti yeTisagenlecleucel inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

• ukuqhina
• isisu esibuhlungu
• umqolo obuhlungu

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko okanye ufumane unyango olungxamisekileyo:

• ukopha okungaqhelekanga okanye ukugruzuka
• igazi kumchamo
• Ukuncipha kokuchama rhoqo okanye isixa
• ukudumba kwamehlo, ubuso, imilebe, ulwimi, umqala, iingalo, izandla, iinyawo, amaqatha okanye imilenze esezantsi
• kunzima ukugwinya
• irhashalala
• urhwebo
• ukurhawuzelela

Inaliti ye-Tisagenlecleucel inokunyusa umngcipheko wokuvela komhlaza othile. Thetha nogqirha wakho malunga neengozi zokufumana eli yeza.

Inaliti yeTisagenlecleucel 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).

Gcina lonke ixesha lokudibana nogqirha wakho, indawo yokuqokelela iiseli, kunye nelabhoratri. Ugqirha wakho angayalela iimvavanyo ezithile zelebhu ngaphambi, ngexesha, nasemva konyango lwakho ukujonga impendulo yomzimba wakho kwisitofu se-tisagenlecleucel.

Ngaphambi kokuba uvavanywe elebhu, xelela ugqirha wakho kunye nabasebenzi baselebhu ukuba ufumana inaliti ye-tisagenlecleucel. Eli yeza linokuchaphazela iziphumo zovavanyo oluthile lwelabhoratri.

Buza usokhemesti wakho ukuba unayo nayiphi na imibuzo onayo malunga ne-tisagenlecleucel injection.

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.

• IKymriya^®