28-noyabr kuni FDA Hodgkin bo'lmagan limfoma (NHL) uchun birinchi rituksimab (Rituxan, rituximab) biosimilar Truxima (rituximab-abbs, Celltrion Inc.) ni tasdiqladi.
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.
Dastlabki dori Roche's Rituxan (rituximab) bo'lib, u birinchi marta 1997 yilda Qo'shma Shtatlarda tasdiqlangan. Ushbu mahsulot uchun boshqa ko'rsatmalar mavjud, shu jumladan romatoid artritni davolash.
Yangi biosimilar Celltrion-dan Truxima (Rituximab-abbs). Xususan, bu kattalardagi bemorlarga tegishli:
1) Monoterapiya sifatida relapsli yoki refrakter, past darajali yoki follikulli, CD20 musbat B hujayra NHL.
2) ilgari davolanmagan follikul sifatida CD20 musbat, B-hujayrali NHL birinchi qatorli kimyoterapiya va rituximabga to'liq yoki qisman javob bergan bemorlar, bir agentli parvarishlash usuli sifatida
3) birinchi darajali siklofosfamid, vinkristin va prednizon (CVP) kimyoviy terapiyasi sifatida, progressiv bo'lmagan (shu jumladan barqaror kasallik), past darajali, CD20 musbat, B hujayrali NHL bitta dori sifatida
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.
