What is the therapeutic effect of Celgene version of Enasidenib in the United States? Is there anything to pay attention to when patients stop taking medication?
Enasidenib, as an IDH2 mutation inhibitor, is mainly used for the treatment of relapsed/refractory AML. Its efficacy is related to the type of mutation, and discontinuation requires gradual reduction and monitoring of hematological and non hematological toxicity.
1. Treatment effect
(1) Overall relief rate
In IDH2 mutation positive AML patients, the complete remission rate is approximately 19% -23%, with or without hematological recovery, totaling 30% -40%. The median duration of remission is 5.6-8.2 months.
(2) Differences in mutation subtypes
The remission rate of R140 mutation patients was significantly higher than that of R172 mutation patients (38% vs 15%), but the remission duration of R172 mutation patients was longer (10.9 vs 5.6 months).
(3) Potential for combination therapy
When combined with azacitidine, the complete remission rate increased to 44%, and the median overall survival was 22 months, significantly better than monotherapy.
2 Precautions for discontinuation of medication
(1) The principle of gradual reduction
In non emergency situations, it is recommended to reduce dosage by 50% every 2 weeks, with a total reduction period of no less than 4 weeks. Sudden discontinuation of medication may induce differentiation syndrome or disease rebound.
(2) Differentiation syndrome monitoring
After discontinuing the medication, symptoms such as fever and difficulty breathing should still be monitored for at least 2 weeks. If they occur, immediate recovery should be achieved by administering 10mg of dexamethasone in combination with amlodipine.
(3) Hematology toxicity management
When the platelet count is less than 50 × 10 ^ 9/L or the neutrophil count is less than 1 × 10 ^ 9/L and lasts for 21 days, the administration should be suspended. After recovery, the dosage should be reduced to 50mg qd and treatment should be restarted.
(4) Liver function follow-up
Within 3 months after discontinuation of medication, ALT/AST should be tested monthly. Due to the possibility of delayed liver injury caused by medication, particular attention should be paid to the dynamic changes in bilirubin levels.
3 Core Storage Conditions
(1) Temperature range
It needs to be stored at room temperature of 20 ° C to 25 ° C, and short-term exposure to 15 ° C to 30 ° C is allowed to avoid drug degradation caused by freezing or high temperature environments.
(2) Avoid light and moisture
The original packaging should be kept sealed and placed in a dry and dark place. After taking out the pills, they should be taken immediately to avoid prolonged exposure to humid air.
Disclaimer：《What is the therapeutic effect of Celgene version of Enasidenib in the United States? Is there anything to pay attention to when patients stop taking medication?》Edited and sorted by Seagull Pharmacy's editors. Please contact us in time if there is any infringement. In addition, the suggestions for drug usage, dosage and disease mentioned in the article are only for medical staff's reference, and can not be used as any basis for medication！