Ngomhla zingama-28 kuNovemba, i-FDA yagunyaza i-rituximab yokuqala (Rituxan, rituximab) biosimilar, Truxima (rituximab-abbs, Celltrion Inc.) ye-non-Hodgkin's lymphoma (NHL).
I-Rituximab iyi-monoclonal antibody ngokumelene ne-CD20. Isetshenziswa kakhulu ku-non-Hodgkin's lymphoma futhi ingasetshenziswa ngokuhambisana nokwelashwa ngamakhemikhali noma iyodwa.
Isidakamizwa sokuqala kwakuyi-Roche's Rituxan (rituximab), eyamukelwa okokuqala e-United States ngo-1997. Kunezinye izinkomba zalo mkhiqizo, kuhlanganise nokwelashwa kwe-arthritis ye-rheumatoid.
I-biosimilar entsha yi-Truxima (Rituximab-abbs) evela ku-Cellrion. Ikakhulukazi, kusebenza ezigulini ezikhulile:
I-1) Njengoba ibuyele emuva noma i-refractory, ibanga eliphansi noma i-follicle, i-CD20 positive B cell NHL njenge-monotherapy
2) Njenge-follicle engazange ilashwe ngaphambili, i-CD20 positive, i-B-cell NHL ehlanganiswe nokwelashwa ngamakhemikhali komugqa wokuqala, kanye neziguli ezithole impendulo ephelele noma ingxenye ye-rituximab ehlanganiswe nokwelashwa ngamakhemikhali, njengokwelashwa kokulondolozwa kwe-ejenti eyodwa.
3) Njenge-cyclophosphamide yomugqa wokuqala, i-vincristine ne-prednisone (CVP) yokwelapha ngamakhemikhali, engaqhubeki (kuhlanganise nesifo esizinzile), izinga eliphansi, i-CD20 positive, i-B cell NHL njengesidakamizwa esisodwa
Izinyathelo zokuphepha zale biosimilar ziyefana nomuthi wangempela, okuhlanganisa ingozi yokusabela ngokufakwa, isikhumba esinzima kanye nokusabela komlomo (okunye okunemiphumela ebulalayo); ukuvuselelwa kwegciwane le-hepatitis B kanye ne-progressive multifocal leukoencephalopathy I-FDA yaphawula ukuthi imiphumela emibi evamile ukusabela kokumnika, umkhuhlane, i-lymphopenia, ukugodola, ukutheleleka, kanye nokuba buthakathaka. Kutuswa ukuthi abahlinzeki bezempilo baqaphe iziguli nge-tumor lysis syndrome, ukusabela okungekuhle kwenhliziyo, i-nephrotoxicity, ukuvinjwa kwamathumbu, nokubhobozwa. Iziguli akufanele zigonywe ngesikhathi sokwelashwa.
