Zvita 2022: Iyo itsva Muvhuro-Chitatu-Chishanu dosing chirongwa cheasparaginase erwinia chrysanthemi (recombinant) -rywn yakabvumidzwa neFood and Drug Administration (Rylaze, Jazz Pharmaceuticals). Varwere vanofanira kugamuchira 25 mg / m2 intramuscularly musi weMuvhuro neChitatu mangwanani uye 50 mg / m2 intramuscularly musi weChishanu masikati pasi peprotocol yakashandurwa. Uyezve, inobvumirwa kuiswa intramuscularly pachiyero che 25 mg / m2 maawa makumi mana nemasere.
In June 2021, the FDA authorised Rylaze as a part of a multi-agent chemotherapy regimen for adult and paediatric patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed an allergy to asparaginase produced from E. coli.
MuChidzidzo JZP458-201 (NCT04145531), yakavhurika-label multicenter kuyedza iyo Rylaze yakaunzwa pamhando dzakasiyana siyana uye nzira, iyo pharmacokinetics yeRylaze yakaongororwa muvarwere ve225. Mhedzisiro yacho yakashandiswa kugadzira modhi yekufanotaura ropa asparaginase chiitiko panguva dzakasiyana dzenguva.
Kubva pakuenzanisa muhuwandu hwekufungidzira, kubudirira uye kuchengetedza kwe nadir serum asparaginase basa (NSAA) pamusoro pezinga re 0.1 U / mL yakashandiswa kuona kushanda. Kutevera 25 mg / m2 dose yeRylaze musi weChitatu mangwanani uye 50 mg / m2 dose musi weChishanu masikati, maererano nemigumisiro yekufananidza, chikamu chevarwere vanochengeta NSAA 0.1 U / mL chaizova 91.6% (95% CI: 90.4%), 92.8%) uye 91.4% (95% CI: 90.1%, 92.6%), maererano.
Neutropenia, anemia, kana thrombocytopenia zvakaonekwa muvarwere vose vakapiwa Rylaze pazviyero zvakaratidzwa sechikamu che-multi-agent chemotherapy. Atypical chiropa kuongororwa, kusvotwa, kurwadziwa kwetsandanyama, kutapukira, kuneta, kutemwa nemusoro, febrile neutropenia, pyrexia, kubuda ropa, stomatitis, kurwadziwa mudumbu, kuderera kwechido chekudya, zvinodhaka hypersensitivity, hyperglycemia, manyoka, pancreatitis, uye hypokalemia ndizvo zvaiwanzoitika zvisina nhematological. > 20%) muvarwere.
View full prescribing information for Rylaze.
