Dec 2022; Nova Lunae-Wednesday-Friday cedula dosing pro asparaginasis erwinia chrysanthemi (recombinante) -rywn a Cibus et medicamentis administrationis approbata est (Rylaze, Jazz Pharmaceuticals). Aegroti 25 mg/m2 intramusculariter die Lunae et Mercurii mane et 50 mg/m2 intramusculare debent die Veneris post meridiem sub protocollo mutato. Accedit intramusculariter infundi dose 25 mg/m2 singulis horis 48.
In June 2021, the FDA authorised Rylaze as a part of a multi-agent chemotherapy regimen for adult and paediatric patients with acuta lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed an allergy to asparaginase produced from E. coli.
In Study JZP458-201 (NCT04145531), pittacium multicenter experimentum apertum in quo Rylaze traditus est variis dosages et modis, pharmacokinetici Rylaze aestimati sunt in 225 aegris. Eventus usi sunt ut exemplar crearent ad praenuntiandum sanguinem asparaginas operationis variis in temporibus.
Substructio simulationis in multitudine ficta, consecutio et conservatio actionis nadir serum asparaginas (NSAA) supra ambitum 0.1 U/mL adhibebatur ad efficaciam determinare. Post 25 mg/m2 dosis Rylaze die Mercurii mane et 50 mg/m2 dosis post meridiem Veneris, secundum eventum simulationis, proportio aegrorum conservantium NSAA 0.1 U/mL esset 91.6% (95% CI: 90.4%; 92.8%) et 91.4% (95% CI: 90.1%, 92.6%), respective.
Neutropenia, anaemia vel thrombocytopenia observata sunt in omnibus aegris Rylaze datis dosage indicata sicut pars chemotherapy multi- agentis. Atypica hepatis probat, nausea, dolor musculoskeletalis, infectiones, lassitudo, capitis dolores, febrilis neutropenia, pyrexia, haemorrhagia, stomatitis, dolor abdominis, appetitus decrescentes, medicamentorum hypersensibilitas, hyperglycemia, diarrhoea, pancreatitis et hypokalemia frequentissimi motus contrarios nonhematologicos (incidentiam. > 20%) In aegris.
View full prescribing information for Rylaze.
