A ranar 28 ga Nuwamba, FDA ta amince da rituximab na farko (Rituxan, rituximab) biosimilar, Truxima (rituximab-abbs, Celltrion Inc.) don lymphoma ba Hodgkin (NHL).
Rituximab shine maganin rigakafi na monoclonal akan CD20. Ana amfani dashi sosai a cikin ƙwayoyin lymphoma ba Hodgkin kuma ana iya amfani dashi a hade tare da chemotherapy ko kadai.
Magungunan asali shine Roche's Rituxan (rituximab), wanda aka fara amincewa da shi a Amurka a 1997. Akwai wasu alamomi don wannan samfur, gami da maganin cutar amosanin gabbai.
Sabuwar biosimilar itace Truxima (Rituximab-abbs) daga Celltrion. Musamman, ya shafi tsofaffin marasa lafiya:
1) Kamar yadda ya sake komawa baya ko kuma ya ki, rashin daraja ko kwaya, CD20 tabbatacce B cell NHL a matsayin monotherapy
2) A matsayin jigon da ba a magance shi ba, CD20 tabbatacce, B-cell NHL haɗe da chemotherapy na farko, da marasa lafiya waɗanda suka sami cikakkiyar amsa ko sashi game da rituximab haɗe da chemotherapy, a matsayin mai kula da kulawa guda ɗaya
3) A matsayin cyclophosphamide na farko, vincristine da prednisone (CVP) chemotherapy, ba ci gaba ba (gami da cuta mai karko), ƙarami, CD20 tabbatacce, B cell NHL azaman magani guda
Kariya ga wannan biosimilar iri ɗaya ne da magungunan asali, gami da haɗarin halayen jiko, mummunan fata da halayen baki (wasu tare da sakamako mai ƙima); Hanta cutar hanta B da ci gaba multifocal leukoencephalopathy FDA ta lura cewa mafi yawan sakamako masu illa sune halayen jiko, zazzabi, lymphopenia, sanyi, kamuwa da cuta, da rauni. Ana ba da shawarar cewa ma'aikatan kiwon lafiya su kula da marasa lafiya don ciwon ciwon tumor lysis, mummunan halayen zuciya, nephrotoxicity, toshewar hanji, da perforation. Kada a yi wa marasa lafiya allurar rigakafi yayin jiyya.
