Désémber 2022: Jadwal dosis Senén-Rebo-Jumaah énggal pikeun asparaginase erwinia chrysanthemi (rékombinan) -rywn parantos disatujuan ku Administrasi Pangan sareng Narkoba (Rylaze, Jazz Pharmaceuticals). Pasén kedah nampi 25 mg / m2 intramuscularly dina Senén sareng Rebo isuk-isuk sareng 50 mg / m2 intramuscularly dina dinten Jumaah soré handapeun protokol anu dirobih. Salaku tambahan, éta diijinkeun pikeun nyuntik intramuskular dina dosis 25 mg / m2 unggal 48 jam.
In June 2021, the FDA authorised Rylaze as a part of a multi-agent chemotherapy regimen for adult and paediatric patients with leukemia limfoblastik akut (ALL) and lymphoblastic lymphoma (LBL) who have developed an allergy to asparaginase produced from E. coli.
Dina Study JZP458-201 (NCT04145531), percobaan multicenter open-labél dimana Rylaze dikirimkeun dina sababaraha dosis sareng metode, pharmacokinetics of Rylaze ditaksir dina pasien 225. Hasilna dianggo pikeun nyiptakeun modél pikeun ngaramalkeun kagiatan asparaginase getih dina sababaraha waktos.
Dumasar kana simulasi dina populasi fiktif, prestasi sareng pangropéa kagiatan sérum asparaginase nadir (NSAA) di luhur tingkat 0.1 U / mL dianggo pikeun nangtukeun efficacy. Saatos dosis 25 mg / m2 Rylaze dinten Rebo enjing sareng dosis 50 mg / m2 dinten Jumaah sonten, dumasar kana hasil simulasi, proporsi pasien anu ngajaga NSAA 0.1 U / ml bakal 91.6% (95% CI: 90.4%, 92.8%) sareng 91.4% (95% CI: 90.1%, 92.6%) masing-masing.
Neutropenia, anémia, atanapi thrombocytopenia dititénan dina sadaya pasien anu dibéré Rylaze dina dosis anu dituduhkeun salaku bagian tina kémoterapi multi-agén. Tes ati atypical, seueul, nyeri muskuloskeletal, inféksi, kacapean, nyeri sirah, neutropenia febrile, pyrexia, perdarahan, stomatitis, nyeri beuteung, turun napsu, hipersensitivitas narkoba, hiperglikemia, diare, pankreatitis, sareng hypokalemia mangrupikeun réaksi anu paling sering aya réaksi nonhématologis. > 20%) dina pasien.
View full prescribing information for Rylaze.
