Enasidenib is a targeted therapeutic drug for specific types of acute myeloid leukemia (AML). As an isocitrate dehydrogenase-2 (IDH2) inhibitor, it provides a new treatment option for patients with relapsed or refractory AML who carry IDH2 mutations.

Indications for Enasidenib

Primary Indications

Enasidenib is specifically indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML), and these patients must have confirmed isocitrate dehydrogenase-2 (IDH2) mutations detected by an FDA-approved testing method.

Target population: Limited to adult patients (aged 18 years and above); the safety and efficacy in pediatric patients have not been established.

Disease type: Relapsed or refractory AML; it is not applicable to patients with newly diagnosed AML.

Molecular marker: Presence of IDH2 mutations (R140 or R172 mutation variants) is mandatory.

Testing requirement: Mutation status must be confirmed using an FDA-approved testing method.

Dosage Forms, Strengths and Properties of Enasidenib

Dosage Forms and Strengths

50 mg tablets: Equivalent to 60 mg of enasidenib mesylate.

100 mg tablets: Equivalent to 120 mg of enasidenib mesylate.

Appearance and Properties

50 mg tablets: Light yellow to yellow oval film-coated tablets, engraved with "ENA" on one side and "50" on the other side.

100 mg tablets: Light yellow to yellow capsule-shaped film-coated tablets, engraved with "ENA" on one side and "100" on the other side.

Composition

Colloidal silicon dioxide.

Hydroxypropyl cellulose.

Hypromellose acetate succinate.

Yellow iron oxide.

Magnesium stearate.

Microcrystalline cellulose.

Storage Methods for Enasidenib

Temperature Requirement

Enasidenib should be stored at 20°C-25°C (68°F-77°F), with short-term exposure to the range of 15°C-30°C (59°F-86°F) allowed.

Packaging Requirements

The drug must be kept in its original bottle.

The bottle cap should be tightened at all times to prevent air and moisture from entering.

The desiccant canister inside the bottle must be retained in place and must not be removed.

Avoid transferring the tablets to other containers for storage.

Moisture-Proof Measures

The bottle cap should be tightly closed immediately after taking the medicine.

Tablets should not be exposed to air for an extended period.

Avoid storing in humid environments such as bathrooms.

Other Precautions

Keep the drug out of the reach of children.

Do not use the drug beyond its expiration date.

Discontinue use if the tablets show abnormal discoloration, deformation, or other abnormal conditions.