Dec 2022: Wani sabon jadawalin adadin litinin-Laraba-Jumma'a don asparaginase erwinia chrysanthemi (recombinant) -rywn an amince da shi ta Hukumar Abinci da Magunguna (Rylaze, Jazz Pharmaceuticals). Ya kamata marasa lafiya su karbi 25 mg / m2 intramuscularly a ranar Litinin da Laraba da safe da 50 mg / m2 intramuscularly a ranar Jumma'a da yamma a karkashin tsarin da aka gyara. Bugu da ƙari, an ba da izinin yin allurar ta cikin jiki a kashi na 25 mg/m2 kowace sa'o'i 48.
In June 2021, the FDA authorised Rylaze as a part of a multi-agent chemotherapy regimen for adult and paediatric patients with m lymphoblastic cutar sankarar bargo (ALL) and lymphoblastic lymphoma (LBL) who have developed an allergy to asparaginase produced from E. coli.
A cikin Nazarin JZP458-201 (NCT04145531), gwajin gwaji na multicenter mai buɗewa wanda aka ba da Rylaze a cikin nau'o'i da hanyoyin daban-daban, an kimanta magungunan Rylaze a cikin marasa lafiya na 225. An yi amfani da sakamakon don ƙirƙirar samfuri don yin hasashen ayyukan asparaginase na jini a lokuta daban-daban.
Dangane da siminti a cikin yawan almara, an yi amfani da nasara da kiyaye ayyukan nadir serum asparaginase (NSAA) sama da matakin 0.1 U/mL don tantance inganci. Bayan 25 mg / m2 kashi na Rylaze a ranar Laraba da safe da kuma 50 mg / m2 kashi a ranar Jumma'a da yamma, bisa ga sakamakon kwaikwayo, adadin marasa lafiya da ke kula da NSAA 0.1 U / mL zai zama 91.6% (95% CI: 90.4%), 92.8%) da 91.4% (95% CI: 90.1%, 92.6%), bi da bi.
An lura da Neutropenia, anemia, ko thrombocytopenia a cikin duk marasa lafiya da aka ba Rylaze a cikin adadin da aka nuna a matsayin wani ɓangare na chemotherapy da yawa. Atypical gwajin hanta, tashin zuciya, ciwon musculoskeletal, cututtuka, gajiya, ciwon kai, febrile neutropenia, pyrexia, hemorrhage, stomatitis, ciwon ciki, rage cin abinci, hypersensitivity na miyagun ƙwayoyi, hyperglycemia, gudawa, pancreatitis, da hypokalemia sun kasance mafi akai-akai rashin hematopoiesis (halin rashin lafiyan halayen). > 20%) a cikin marasa lafiya.
View full prescribing information for Rylaze.
