What are the side effects of Rezlidhia (Olutasidenib)?

In patients with acute myeloid leukemia (AML) and IDH1 mutations, Rezlidhia (olutasidenib) caused a 59.1% decrease in 2-hydroxyglutarate (2-HG) levels before the second dosing cycle. 2-HG levels remained reduced throughout the treatment period. An association between increased exposure to Rezlidhia and an increased probability of differentiation syndrome and grade 3 hepatotoxicity was also detected in AML patients treated with Rezlidhia. Use of Rezlidhia results in a concentration-dependent increase in the QTc interval.

In clinical trials of relapsed or refractory acute myeloid leukemia, the most common (≥20%) adverse reactions (including laboratory abnormalities) include increased aspartate aminotransferase, increased alanine aminotransferase, decreased potassium Low, decreased sodium, increased alkaline phosphatase, nausea, increased creatinine, fatigue/malaise, joint pain, constipation, elevated lymphocytes, elevated bilirubin, leukocytosis, elevated uric acid, dyspnea, pyrexia, rash, elevated lipase, mucositis, diarrhea, and elevated transaminases. Clinically relevant adverse reactions occurred in <10% of patients treated with Rezlidhia, including biliary tract disease, biliary colic, cholangitis and cholestasis, and QT prolongation on the electrocardiogram.

Toxicity information aboutRezlidhia is not readily available. Patients who overdose are at increased risk for serious adverse reactions such as differentiation syndrome and hepatotoxicity. In vivo studies to evaluate the carcinogenicity of Rezlidhia have not been performed. Rezlidhia was not genotoxic in in vitro bacterial reverse mutation and human lymphocyte micronucleus assays and in vivo in rat bone marrow micronucleus assays. The effects of Rezlidhia on fertility have not been evaluated. In vitro and in vivo studies have shown that Rezlidhia is phototoxic. Pigmented rats that received Rezlidhia orally for 3 days and were exposed to UV light 2 hours after the last dose developed skin erythema that lasted 72 hours.

After Rezlidhia is approved for marketing, there is little information about its price and other related information. Please consult the medical consultant for details.