1. Indications:

Enacitib (Enasidenib) 100 mg is indicated for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adult patients with an isocitrate dehydrogenase 2 (IDH2) mutation, as detected by an FDA-approved test.

2. Pharmacology:

Enacitib (Enasidenib) 100 mg exerts its pharmacological effects by selectively inhibiting mutated IDH2 enzymes, specifically those with the R140 and R172 substitutions. By blocking these mutated enzymes, Enacitib disrupts abnormal cellular metabolism, promotes differentiation of leukemia cells, and inhibits their proliferation, ultimately leading to suppression of leukemic growth.

3. Dosage and Administration:

The recommended dosage of Enacitib (Enasidenib) 100 mg is one tablet taken orally once daily, with or without food. Treatment should continue until disease progression, unacceptable toxicity, or other treatment discontinuation criteria are met. Dose adjustments or discontinuation may be necessary based on individual patient response and tolerability.

4. Interaction:

Enacitib (Enasidenib) 100 mg may interact with other medications, including:

• Strong CYP3A4 inhibitors or inducers: Co-administration with drugs that affect CYP3A4 metabolism may alter the plasma concentration of Enacitib.
• Acid-reducing agents: Concurrent use of proton pump inhibitors (PPIs) or H2-receptor antagonists may decrease the absorption of Enacitib, potentially reducing its efficacy.

Patients should inform their healthcare provider about all medications they are taking, including prescription, over-the-counter, and herbal products, to avoid potential interactions.

5. Side Effects:

Common side effects associated with Enacitib (Enasidenib) 100 mg may include:

• Nausea
• Diarrhea
• Fatigue
• Increased bilirubin levels
• Decreased appetite
• Edema

Patients should report any persistent or severe side effects to their healthcare provider for further evaluation and management.

6. Precautions and Warnings:

Before using Enacitib (Enasidenib) 100 mg, patients should be aware of the following precautions:

• Enacitib may cause differentiation syndrome, a potentially life-threatening complication characterized by fever, dyspnea, and multi-organ dysfunction. Patients should be monitored closely for signs and symptoms of differentiation syndrome during treatment.
• Hepatotoxicity, including liver function abnormalities, has been reported with Enacitib. Liver function tests should be performed before starting treatment and periodically thereafter.
• Enacitib may prolong the QT interval, increasing the risk of arrhythmias. Electrocardiograms (ECGs) should be monitored regularly, especially in patients with pre-existing cardiac conditions.

7. Overdose Effects:

In case of overdose with Enacitib (Enasidenib) 100 mg, supportive care should be initiated, and symptomatic treatment may be administered as necessary. There is no specific antidote for Enacitib overdose, and patients should seek immediate medical attention if overdose is suspected.