What are the precautions for Enasidenib?

Among the warnings and precautions emerging from Enasidenib clinical studies, differentiation syndrome and embryo-fetal toxicity are more common, and differentiation syndrome may be fatal if not treated. Therefore, if differentiation syndrome is suspected in a patient during treatment with ensidipine, corticosteroid therapy and hemodynamic monitoring should be initiated as directed by the physician until symptoms resolve.

1. Differentiation syndrome: This phenomenon may be related to the rapid proliferation and differentiation of bone marrow cells. Although there are no diagnostic tests for differentiation syndrome, symptoms in patients treated with ensidipine include acute respiratory distress represented by dyspnea and/or hypoxia and the need for supplemental oxygen, pulmonary infiltrates and pleural effusion, renal impairment, fever, lymphadenopathy, bone pain, peripheral edema with rapid weight gain, pericardial effusion, and hepatic, renal, and multiorgan dysfunction were also observed.

Differentiation syndrome with and without hyperleukocytosis may be observed as early as 1 day to 5 months after initiation of ensidipine. If differentiation syndrome is suspected, initiate oral or intravenous corticosteroids (eg, dexamethasone 10 mg every 12 hours) and hemodynamic monitoring until improvement. Taper corticosteroids only after symptoms have resolved. Symptoms of differentiation syndrome may return with premature discontinuation of corticosteroid therapy. If severe pulmonary symptoms and/or renal dysfunction requiring intubation or ventilator support persist for more than 48 hours after starting corticosteroids, interrupt ensidipine until symptoms and signs are no longer severe. Hospitalization is recommended for close observation and monitoring of patients with pulmonary and/or renal manifestations.

2. Embryo-Fetal Toxicity: According to animal embryo-Fetotoxicity studies, ensidipine will cause embryo-fetal harm when taken by pregnant women. In animal embryo-fetal toxicity studies, enacinib initiated embryo-fetal toxicity at 0.1 times the steady-state clinical exposure based on the area under the concentration-time curve (AUC) at the recommended human dose. Doctors will inform pregnant women of potential risks to the fetus. Advise females of childbearing potential to use effective contraception during treatment with ensidipine and for at least 2 months after the last dose. Advise male and female partners of childbearing potential to use effective contraception during treatment with ensidipine and for at least 2 months after the last dose.

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 ensidipine drugs produced by other pharmaceutical companies overseas, such as Specifications50mg* produced by Bangladesh Pharmaceutical Factory.The price of each box of 60 tablets may be around RMB 4,000 (the price may fluctuate due to the exchange rate), and its pharmaceutical ingredients are basically the same as those of Enxidi plain medicine.