A must-read for patients: An overview of basic information in the instructions for use of Enasidenib

1. Generic names: Enasidenib,Enasidenib

Product name:Idhifa

Other names: Enanib, Enadni

2. Who can take ensidipine? Indications?

Enasidenib (Enasidenib) is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have isocitrate dehydrogenase-2 (IDH2) mutations.

3. What are the side effects of ensidipine?

The most common adverse reactions (≥20%) of ensidipine are nausea, vomiting, diarrhea, increased bilirubin, and decreased appetite; the most common serious adverse reactions (≥2%) are leukocytosis, diarrhea, nausea, vomiting, decreased appetite, tumor lysis syndrome, and differentiation syndrome. Dialectical events characterized by severity include fever, acute renal failure, hypoxia, respiratory failure, and multiple organ failure.

4. How should you take ensidipine?

The recommended dose of ensidipine is100 mg orally administered once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for at least 6 months to allow time for clinical response.

Patients should swallow the tablets whole. Do not chew, split, or crush ensidipine tablets. Take by mouth at approximately the same time each day. If you vomit, miss, or do not take a dose of ensidipine at the normal time, take it as soon as possible that day and resume your normal schedule the next day.

5. How to store ensidipine?

Ensidipine is storage temperature20°C-25°C (68°F-77°F); excursions allowed between 15°C-30°C (59°F-86°F). Store in the original bottle (with desiccant canister) to protect it from moisture.

6. How does enxidipine work?

Ensidipine is a small molecule inhibitor of isocitrate dehydrogenase2 (IDH2) enzyme. Ensidipine targets mutant IDH2 variants R140Q, R172S, and R172K in vitro at approximately 40-fold lower concentrations than the wild-type enzyme. In a mouse xenograft model of IDH2-mutant AML, inhibition of the mutant IDH2 enzyme by ensidipine resulted in reduced 2-hydroxyglutarate (2-HG) levels and induction of myeloid differentiation in vitro and in vivo. In blood samples from AML patients with mutated IDH2, ensidipine reduced 2-HG levels, reduced blast counts, and increased the percentage of mature myeloid cells.

7. Who cannot use Ensidipine?

Based on animal studies, ensidipine may impair fertility in both female and male animals of reproductive potential. It is not known whether these effects on fertility are reversible;women of childbearing potential should therefore use effective contraception during treatment and for 2 months after the last dose.