Disemba 2022: Uhlelo olusha lokudosa lwangoMsombuluko-ngoLwesithathu-uLwesihlanu lwe-asparaginase erwinia chrysanthemi (i-recombinant)-rywn lugunyazwe i-Food and Drug Administration (Rylaze, Jazz Pharmaceuticals). Iziguli kufanele zithole u-25 mg/m2 nge-intramuscularly ngoMsombuluko nangoLwesithathu ekuseni kanye no-50 mg/m2 nge-intramuscularly ngoLwesihlanu ntambama ngaphansi kwephrothokholi eguquliwe. Ukwengeza, kuvunyelwe ukujova nge-intramuscularly ngethamo lika-25 mg/m2 njalo emahoreni angama-48.
In June 2021, the FDA authorised Rylaze as a part of a multi-agent chemotherapy regimen for adult and paediatric patients with I-acute lymphoblastic leukemia (YONKE) and lymphoblastic lymphoma (LBL) who have developed an allergy to asparaginase produced from E. coli.
Ku-Study JZP458-201 (NCT04145531), ukuhlolwa kwelebula evulekile ye-multicenter lapho i-Rylaze ilethwa khona ngemithamo ehlukahlukene nezindlela, i-pharmacokinetics ye-Rylaze yahlolwa ezigulini ze-225. Imiphumela yasetshenziselwa ukudala imodeli yokubikezela umsebenzi we-asparaginase yegazi ngezikhathi ezihlukahlukene zesikhathi.
Ngokusekelwe ekulingiseni kumphakathi oqanjiwe, ukuzuza nokugcinwa komsebenzi we-nadir serum asparaginase (NSAA) ngaphezu kwezinga elingu-0.1 U/mL kwasetshenziswa ukuze kutholwe ukusebenza kahle. Ukulandela umthamo wama-25 mg/m2 we-Rylaze ngoLwesithathu ekuseni kanye nomthamo ongu-50 mg/m2 ngoLwesihlanu ntambama, ngokwemiphumela yokulingisa, ingxenye yeziguli ezigcina i-NSAA engu-0.1 U/mL izoba ngu-91.6% (95% CI: 90.4%), 92.8%) kanye 91.4% (95% CI: 90.1%, 92.6%), ngokulandelana.
I-Neutropenia, i-anemia, noma i-thrombocytopenia yabonwa kuzo zonke iziguli ezinikezwe i-Rylaze ngemithamo ebonisiwe njengengxenye yokwelapha ngamakhemikhali amaningi. Ukuhlolwa kwesibindi okungavamile, isicanucanu, ubuhlungu bemisipha namathambo, izifo, ukukhathala, ikhanda, i-febrile neutropenia, i-pyrexia, ukopha, i-stomatitis, ubuhlungu besisu, ukuncipha kwesifiso sokudla, ukuzwela kwezidakamizwa, i-hyperglycemia, isifo sohudo, i-pancreatitis, kanye ne-hypokalemia kwakuyizinto ezivame ukuvela e-nonhematological > 20%) ezigulini.
View full prescribing information for Rylaze.
