Enxi Diping Chinese Detailed Instructions

Enasidenib is an oral targeted inhibitor used to treat a specific type of leukemia: newly diagnosed, refractory or relapsed acute myeloid leukemia (AML). It acts as an IDH2 (isocitrate dehydrogenase 2) inhibitor in AML patients with IDH2 mutations.

1. Drug name: Ensidipine (Enasidenib)

2. Common name: ensidipine

3. Drug classification: Ensidipine is a targeted inhibitor that specifically acts on the IDH2 enzyme.

4. Indications: For patients with newly diagnosed, refractory or relapsed AML (acute myeloid leukemia) with IDH2 mutations.

5. Pharmacological effects: Ensidipine is an oral drug that reduces the level of 2-hydroxyvaleric acid (2-HG) by specifically inhibiting the activity of the IDH2 enzyme. IDH2Mutation leads to an abnormal increase in IDH2 enzyme activity, producing a large amount of 2-HG, resulting in interference with cell differentiation and proliferation. Ensidipine works by restoring normal cell differentiation and proliferation, thereby inhibiting the development of AML.

6. Usage and Dosage: Ensidipine is usually taken as an oral drug. It is recommended to take it once a day at a dose of 100 mg. Physicians may adjust dosage based on patient's clinical response and tolerability.

7. Contraindications:

Patients who are allergic to ensidipine or any ingredient in the medicine.

Patients receiving concomitant use with strong inhibitors of CYP3A4 (such as ketoconazole, erythromycin).

Pregnant and breastfeeding women.

8. Adverse reactions: Ensidipine may cause some adverse reactions, including but not limited to:

Gastrointestinal reactions: such as nausea, vomiting, diarrhea, etc.

Abnormal liver function: such as elevated transaminases, jaundice, etc.

Others: such as fatigue, headache, fever, etc.

9. Notes and warnings:

During the use of ensidipine, patients may need to regularly monitor liver function, blood and other related indicators.

Patients should avoid concomitant use with strong inhibitors and inducers of CYP3A4 while receiving ensidipine.

The use of ensidipine should be avoided during pregnancy, and female patients should take effective contraceptive measures during treatment.

10. Drug Interactions: Ensidipine may interact with other drugs, especially strong inhibitors and inducers of CYP3A4. Patients should tell their doctor about all medications they are taking, including prescription drugs, over-the-counter drugs, and supplements, before receiving treatment.

11. Pregnant and nursing women: The safety of ensidipine in pregnant and nursing women has not been established. Pregnant and breastfeeding women should consult their doctor before using ensidipine.

12. Drug storage: Ensidipine should be stored in the original sealed packaging, away from light and moisture. The storage temperature is generally between 15-30 degrees Celsius.

13. Overdose: Overdose of ensidipine may cause serious adverse reactions, including poisoning and death. If an overdose is suspected, the patient should seek medical attention immediately.

14. Clinical trials and effects: Clinical trials have shown that ensidipine has demonstrated significant anti-tumor activity in the treatment of IDH2 mutated AML patients, and produced durable clinical responses in some patients.

15. Drug Manufacturer: Ensidipine is manufactured byAgios Pharmaceuticals.

16. Drug Approval Status: Ensidipine has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with newly diagnosed, refractory, or relapsed AML harboring IDH2 mutations.

In summary, ensidipine, an IDH2 inhibitor, provides an effective oral treatment option for patients with newly diagnosed, refractory, or relapsed AML with IDH2 mutations. Patients should read the instructions carefully before using ensidipine and follow the doctor's recommendations and instructions to ensure safe and effective use of the drug.