Diseembar 2022: Jadwal cusub oo Isniin-Arbaca-Jimce ah oo loogu talagalay asparaginase erwinia chrysanthemi (recombinant) -rywn waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka (Rylaze, Jazz Pharmaceuticals). Bukaan-socodka waa in ay qaataan 25 mg/m2 intramuscularly isniinta iyo arbacada subaxda iyo 50 mg/m2 intramuscularly jimcaha galabtii iyadoo la raacayo nidaamka la bedelay. Intaa waxaa dheer, waxaa la oggol yahay in lagu duro muruqa-muruqa oo ah qiyaas ah 25 mg/m2 48 saacadood kasta.
In June 2021, the FDA authorised Rylaze as a part of a multi-agent chemotherapy regimen for adult and paediatric patients with lymphoblastic leukemia ba'an (ALL) and lymphoblastic lymphoma (LBL) who have developed an allergy to asparaginase produced from E. coli.
Daraasadda JZP458-201 (NCT04145531), tijaabo furan oo calaamado badan leh oo Rylaze lagu keenay qiyaaso iyo habab kala duwan, farmasokinetics ee Rylaze ayaa lagu qiimeeyay bukaanada 225. Natiijooyinka waxaa loo adeegsaday si loo abuuro qaab lagu saadaaliyo dhaqdhaqaaqa asparaginase dhiigga waqtiyo kala duwan.
Iyadoo lagu salaynayo jilitaanka dad khayaali ah, kasbashada iyo dayactirka waxqabadka nadir serum asparaginase (NSAA) ee ka sarreeya heerka 0.1 U/mL ayaa la isticmaalay si loo go'aamiyo waxtarka. Ka dib qiyaasta 25 mg / m2 ee Rylaze subaxnimadii Arbacada iyo qiyaasta 50 mg / m2 galabnimadii Jimcaha, marka loo eego natiijooyinka jilitaanka, saamiga bukaannada ilaalinaya NSAA 0.1 U / mL waxay noqon doontaa 91.6% (95% CI: 90.4%), 92.8%) iyo 91.4% (95% CI: 90.1%, 92.6%), siday u kala horreeyaan.
Neutropenia, dhiig-yaraan, ama thrombocytopenia ayaa lagu arkay dhammaan bukaannada la siiyay Rylaze ee qiyaasta la tilmaamay iyada oo qayb ka ah daaweynta kiimikaad badan. Baaritaannada beerka aan caadiga ahayn, lallabbo, xanuunka murqaha, caabuqa, daal, madax-xanuun, qandho neutropenia, pyrexia, dhiigbaxa, stomatitis, calool xanuun, rabitaanka cuntada oo yaraada, dareenka daroogada, hyperglycemia, shuban, pankreatit, iyo hypokalemia ayaa ahaa kuwa ugu badan ee aan caadi ahayn > 20%) bukaanada.
View full prescribing information for Rylaze.
