Ar an 28 Samhain, d'fhormheas FDA an chéad biosimilar rituximab (Rituxan, rituximab), Truxima (rituximab-abbs, Celltrion Inc.) le haghaidh liomfóma neamh-Hodgkin (NHL).
Rituximab is a monoclonal antibody against CD20. It is widely used in non-Hodgkin’s lymphoma and can be used in combination with chemotherapy or alone.
Ba é an druga bunaidh Roche's Rituxan (rituximab), a ceadaíodh den chéad uair sna Stáit Aontaithe i 1997. Tá tásca eile ann don táirge seo, lena n-áirítear cóireáil airtríteas réamatóideach.
Is é an bithshábháilteacht nua Truxima (Rituximab-abbs) ó Celltrion. Baineann sé go sonrach le hothair aosacha:
1) Mar athiompaithe nó teasfhulangach, grád íseal nó follicle, CD20 CD B dearfach CD mar monotherapy
2) Mar follicle gan chóireáil roimhe seo, CD20 dearfach, NHL B-chill in éineacht le ceimiteiripe céadlíne, agus othair a fuair freagra iomlán nó páirteach ar rituximab in éineacht le ceimiteiripe, mar chóireáil chothabhála aon-ghníomhaire
3) Mar cheimiteiripe céadlíne ciogeafosfamíd, vincristine agus prednisone (CVP), neamh-fhorásach (lena n-áirítear galar cobhsaí), grád íseal, CD20 dearfach, NHL NHL B mar dhruga aonair
The precautions for this biosimilar are the same as the original drug, including the risk of infusion reactions, severe skin and oral reactions (some with fatal consequences); hepatitis B virus reactivation and progressive multifocal leukoencephalopathy The FDA noted that the most common side effects are infusion reactions, fever, lymphopenia, chills, infection, and weakness. It is recommended that healthcare providers monitor patients for tumor lysis syndrome, adverse cardiac reactions, nephrotoxicity, intestinal obstruction, and perforation. Patients should not be vaccinated during treatment.
