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Ensidipine's innovative therapy provides new treatment options for AML patients, especially those who have failed or relapsed with traditional treatments.
1. Generic name:Enasidenib
2. Trade name: IDHIFA®
50 mg, tablets
1. Active ingredient: Ensidipine mesylate (50 mg tablet contains 60 mg mesylate, 100 mg tablet contains 120 mg mesylate).
2. Excipients include colloidal silica, hydroxypropyl cellulose, polyvinyl alcohol, etc.
1. Recommended dose: Take 100 mg orally once a day until disease progression or intolerable toxicity occurs.
2. How to take: Swallow the tablet whole, do not chew or break it. It can be taken with food or on an empty stomach.
1. Treatment of adverse reactions:
(1) Differentiation syndrome: medication needs to be suspended and corticosteroid treatment given, and medication should be resumed after symptoms are relieved.
(2) Infectious leukocytosis: If hydroxyurea is ineffective, suspend the medication and reduce the dose to 50 mg/day after the white blood cell count recovers.
(3) Elevated bilirubin persists for ≥ 2 weeks: reduce the dose to 50 mg/day, and then return to 100 mg/day after recovery.
2. Other toxicities of grade ≥3: Suspend medication until symptoms are relieved, restart at 50 mg/day after recovery, and permanently discontinue medication if necessary.
1. Missing a dose or vomiting: If you miss a dose or vomit on the same day, you should take the same dose as soon as possible, and resume the normal medication time the next day. Double dose compensation is not allowed.
2. Monitoring requirements: Before treatment and at the beginning of treatment, blood routine and blood biochemistry need to be monitored every two weeks to be wary of tumor lysis syndrome.
1. Pregnancy: Contraindicated as it may cause fetal damage. Effective contraception is required during medication and within 1 month after stopping the medication.
2. Lactation period: Breastfeeding is prohibited during treatment and within 1 month after the last dose.
3. Elderly patients: No dose adjustment is required, but close monitoring is required.
1. Common (≥20%) include:nausea, vomiting, diarrhea, increased bilirubin and decreased appetite;
2. Serious adverse reactions include:differentiation syndrome (14%), leukocytosis (10%) and tumor lysis syndrome (5%).
There are no clear contraindications, but it is absolutely contraindicated during pregnancy.
1. It may affect the efficacy of hormonal contraceptives. It is recommended to use other contraceptive methods.
2. Caution is required when combined with CYP enzyme inhibitors or inducers, as ensidipine metabolism may be altered.
1. Store in the original bottle with built-in desiccant to avoid moisture.
2. Store at room temperature (20°C-25°C). Short-term storage at 15°C-30°C is allowed.