The innovative therapy of amlodipine provides a new treatment option for AML patients, especially those who have failed or relapsed with traditional treatments.

1、 Drug name

1. Common name: Enasidenib

2. Product Name: IDHIFA ®

2、 Indications

Used to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) confirmed by FDA approved testing to have isocitrate dehydrogenase-2 (IDH2) mutations.

3、 Specifications and characteristics

50mg, tablet

4、 Main components

1. Active ingredient: Ensidipine mesylate (60mg mesylate in 50mg tablets, 120mg mesylate in 100mg tablets).

2. Auxiliary materials include colloidal silica, hydroxypropyl cellulose, polyvinyl alcohol, etc.

5、 Usage and dosage

1. Recommended dosage: Take 100 milligrams orally once daily until disease progression or intolerable toxicity occurs.

2. Usage: Swallow the whole tablet, do not chew or break it open, can be taken with food or on an empty stomach.

6、 Dose adjustment

1. Adverse reaction management:

(1) Differentiation syndrome: Medication should be temporarily suspended and corticosteroid treatment should be given. Medication should be resumed after symptoms are relieved.

(2) Infectious leukocytosis: If hydroxyurea is ineffective, the medication should be suspended, and the white blood cell count should be reduced to 50 milligrams per day after recovery.

(3) Elevated bilirubin levels persist for ≥ 2 weeks: reduce to 50 milligrams per day and return to 100 milligrams per day after recovery.

2. Other toxicity levels ≥ 3: Suspend medication until symptoms improve, restart at 50mg/day after recovery, and permanently discontinue if necessary.

7、 Medication precautions

1. Omission or vomiting: If missed or vomited on the same day, the same dose should be taken as soon as possible, and the normal medication time should be restored the next day. Double dose compensation is not allowed.

2. Monitoring requirements: Blood routine and blood biochemistry should be monitored every two weeks before and during the early stages of treatment to be alert to tumor lysis syndrome.

8、 Medication for special populations

1. Pregnancy period: Prohibited, may cause fetal damage, effective contraception should be used during medication and within one month after discontinuation.

2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and within one month after the last administration.

3. Elderly patients: No need to adjust dosage, but close monitoring is required.

9、 Adverse reactions

1. Common (≥ 20%) symptoms include nausea, vomiting, diarrhea, elevated bilirubin levels, and decreased appetite;

2. Serious adverse reactions include differentiation syndrome (14%), leukocytosis (10%), and tumor lysis syndrome (5%).

10、 Contraindications

There are no clear contraindications, but it is absolutely prohibited during pregnancy.

11、 Drug interactions

1. May affect the efficacy of hormonal contraceptives, it is recommended to use other contraceptive methods.

2. Caution should be exercised when using CYP enzyme inhibitors or inducers in combination, as it may alter the metabolism of Ensidipine.

12、 Storage method

1. Store in original bottle with built-in desiccant to avoid moisture.

2. Store at room temperature (20 ° C-25 ° C) and allow short-term storage at 15 ° C-30 ° C.

Enasidenibinformation