Precautions before use of Enasidenib

During clinical use of Enasidenib, two common warnings and precautions have emerged: differentiation syndrome and embryo-fetal toxicity.

First, differentiation syndrome is a common side effect of ensidipine treatment and may be related to the rapid proliferation and differentiation of bone marrow cells. Patients with acute myeloid leukemia(AML) usually present with symptoms such as acute respiratory distress, dyspnea or hypoxia, pulmonary infiltrates, pleural effusion, renal damage, fever, lymphadenopathy, bone pain, peripheral edema with rapid weight gain, and pericardial effusion. This syndrome may occur within 1 day to 5 months after initiation of ensidipine, with or without hyperleukocytosis.

If differentiation syndrome is suspected, corticosteroid therapy (eg, dexamethasone 10 mg every 12 hours) should be initiated immediately and hemodynamic monitoring should be performed until symptoms resolve. If symptoms do not improve or severe pulmonary symptoms and/or renal dysfunction occur for more than 48 hours, ensidipine treatment should be interrupted until symptoms resolve and stability returns. Symptoms of differentiation syndrome may recur after discontinuation of corticosteroid therapy and should therefore be closely observed and managed.

Secondly, the use of ensidipine in pregnant women can cause potential harm to the embryo and fetus. Animal tests have shown that ensidipine can cause embryo-fetal toxicity at recommended doses, so pregnant women should avoid using this drug. Advise females of childbearing potential to use effective contraception while taking ensidipine and for at least 2 months after the last dose. Male patients and their partners should follow similar contraceptive recommendations to prevent potential effects on the fetus.

In summary, when using ensidipine, you need to be alert to the occurrence of differentiation syndrome and take timely intervention measures. At the same time, women who are pregnant or planning to become pregnant must avoid using this drug and take appropriate contraceptive measures.

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