Ensidnib ENASIDENIB 50 MG Approval No. 07 L 1138/24 Valid until 11-7-2027

Enasidenib (trade name: Ensidnib) is a targeted therapy drug mainly used to treat patients with acute myeloid leukemia (AML), especially those with IDH2 gene mutations . The following is the basic information of Enasidenib:

1. Drug classification :

• Enasidenib is an oral IDH2 inhibitor used for the targeted treatment of acute myeloid leukemia (AML) carrying IDH2 gene mutations . IDH2 mutations usually lead to abnormal proliferation of leukemia cells. Enasidenib inhibits the activity of IDH2 enzymes and restores normal hematopoietic function, thereby inhibiting the growth of cancer cells.

2. Indications :

• Acute Myeloid Leukemia (AML) : For the treatment of adult patients with acute myeloid leukemia with an IDH2 gene mutation , especially those who have not responded to or have relapsed from previous treatment.

3. Usage and dosage :

• aldult :
  • The recommended dose is 100 mg once daily .
  • The medication should be taken orally, preferably at the same time each day, either before or after a meal.
  • Dose adjustment : The dose may need to be adjusted based on the patient's tolerance and efficacy. If severe side effects occur, the dose may be reduced or the drug may be temporarily discontinued.
• Special populations : For patients with impaired liver function or other specific pathological conditions, the dosage needs to be adjusted according to the doctor's instructions.

4. Notes :

• Liver function : Enasidenib may cause abnormal liver function. Liver function (such as liver enzyme levels) needs to be monitored regularly during use.
• Hematological monitoring : Patients may experience hematological abnormalities such as hypoglycemia and low platelets, so regular blood tests are required during treatment.
• Pregnancy and lactation : Enasidenib may cause fetal harm and is not recommended for use during pregnancy. If you are breastfeeding, avoid breastfeeding while taking this medicine.
• Drug interactions : Enasidenib may interact with certain drugs, especially those involved in the CYP3A4 metabolic pathway. When using Enasidenib, you need to inform your doctor of all the drugs you are currently taking.

5. Side effects :

• Common side effects :
  • Nausea, loss of appetite, fatigue, vomiting, diarrhea, jaundice, hypoglycemia, etc.
• Serious side effects :
  • Hepatotoxicity : Hepatic impairment, such as jaundice or liver failure, may occur; regular monitoring of liver function is essential.
  • Hematological abnormalities : such as leukopenia, thrombocytopenia, anemia, etc., hematological support may be required.
  • Hypoglycemia : Patients may experience symptoms of hypoglycemia, especially at the beginning of treatment, and blood sugar should be monitored regularly.

If serious side effects occur, contact your doctor immediately for treatment.

6. Contraindications :

• Enasidenib is contraindicated in patients with hypersensitivity to it or any of its components.
• It should be used with caution in patients with severe hepatic impairment, particularly in the presence of significant liver disease or hepatic insufficiency.

7. Pregnancy and lactation :

• Pregnancy : Enasidenib may be harmful to the fetus, so it should be avoided during pregnancy. If it must be used, the risk should be assessed under the guidance of a doctor.
• Lactation : Enasidenib may be excreted in breast milk and is not recommended for use during breastfeeding.

8. Storage :

• Enasidenib should be stored at room temperature (15°C to 30°C) away from moisture and direct sunlight. Keep out of the reach of children.

9. Other matters needing attention :

• Monitoring : During the use of Enasidenib, patients need to undergo regular blood tests, liver function monitoring, etc. to ensure drug safety.
• During treatment : Patients should follow the doctor's instructions, take medication on time, and avoid adjusting the dosage on their own. If side effects occur, they should inform the doctor immediately to ensure timely treatment.

Summarize:

Enasidenib (Ensidnib) is a targeted drug used to treat IDH2 mutant acute myeloid leukemia (AML), which can significantly improve the treatment effect of patients. Regular liver function and hematology monitoring are required during treatment, and the doctor's advice should be followed to ensure the safe and effective use of the drug.

Please note : This description is for reference only. The specific treatment plan should be formulated according to the doctor's advice and the patient's specific situation. Before using Enasidenib, please read the drug instructions carefully and consult a doctor to ensure safety.