Enasidenib Differentiation Syndrome

Enasidenib (Enasidenib) is a targeted therapy drug approved by the U.S. Food and Drug Administration (FDA) for acute myeloid leukemia (AML). Ensidipine's label contains a boxed warning, which is the most prominent warning issued by the FDA about serious side effects caused by differentiation syndrome. In clinical conducted studies, 14% of patients treated with ensidipine developed differentiation syndrome, which may be life-threatening or fatal if left untreated.

Differentiation syndrome is a disease that affects the immune system. It occurs because the anti-cancer effect of the drug on leukemia cells leads to the rapid release of large amounts of cytokines (inflammatory immune proteins). The onset of differentiation syndrome has been observed from the first day of treatment with ensidipine until 5 months after the start of treatment. Differentiation syndrome results in the rapid expansion of myeloid cells, such as neutrophils, monocytes, and macrophages, which are important components of the immune system. If differentiation syndrome is suspected, initiate oral or intravenous corticosteroids (eg, dexamethasone 10 mg every 12 hours) and hemodynamic monitoring until improvement.

Ensiidi plain investigational medicine is not currently on the market in the country, nor is it covered by medical insurance. The price of ensidipine plain medicine when it is launched overseas is very high, and the price of each box may be around 30,000 yuan (the price may fluctuate due to the exchange rate). Currently, there are cheaper generic encidipine drugs produced by other pharmaceutical companies overseas. For example, the price of Specification50mg*60 tablets produced by a Bangladesh pharmaceutical factory may be around 4,000 yuan per box (the price may fluctuate due to exchange rates). Its drug ingredients are basically the same as those of the original encidipine generic drug.