Enasidenib, ENASIDX, Enasidenib 50mg Manufacturer: Laos Daxiong Pharmaceutical

Introduction: On August 1, 2017, the US FDA approved the marketing of ensidipine, becoming the first anticancer drug targeting tumor metabolism. It is mainly used to treat relapsed or refractory acute myeloid leukemia in adults with isocitrate dehydrogenase 2 (IDH2) gene mutations.

【Drug name】

Name: Ensidipine Tablets

Product Name: ENASIDX

English name: Enasidenib Tablets

【Specification】

50 mg

【Indications】

ENASIDX is a prescription medicine used to treat people with acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation whose disease has relapsed or has not improved after previous treatment.

It is not known if ENASIDX is safe and effective in children.

【Recommended dose】

• Take ENASIDX exactly as your healthcare provider tells you to.

• Take ENASIDX 1 time each day at the same time.

• Swallow ENASIDX tablets whole. Do not chew or split the tablets.

• Swallow ENASIDX with 8 ounces (a glass) of water.

• ENASIDX may be taken with or without food.

• If you miss a dose of ENASIDX or vomit after taking a dose of ENASIDX, take that dose of ENASIDX as soon as possible that day. Then take your next dose at your scheduled time the next day. Do not take 2 doses at the same time to make up for a missed dose.

• Your healthcare provider should do blood tests to check your blood counts before starting ENASIDX treatment and at least every two weeks during treatment for at least the first 3 months to check for side effects.

【side effect】

ENASIDX may cause serious side effects, including:

ENASIDX may cause serious side effects, including:

o Differentiation syndrome. Differentiation syndrome is a disorder that affects blood cells and can be life-threatening or cause death if not treated. Differentiation syndrome can occur within 10 days to 5 months after starting ENASIDX. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following symptoms of differentiation syndrome while taking ENASIDX:

o Fever

Oh cough

o Shortness of breath

o Swelling in the arms and legs

o Swelling in the neck, groin, or underarm area

o Rapid weight gain (more than 10 pounds in one week)

o Bone pain

If you have any of these differentiation syndrome symptoms, your healthcare provider may start you on corticosteroid medications, either by mouth or through a vein (intravenously), and may monitor you in the hospital.

The most common side effects of ENASIDX include:

Nausea

Vomiting

o Diarrhea

Jaundice

o Decreased appetite

Tell your healthcare provider if you have any changes in your skin color or the whites of your eyes.

Your healthcare provider will monitor you for side effects during treatment and may tell you to stop taking ENASIDX if you get certain side effects.

These are not all the possible side effects of ENASIDX.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

【Storage】

• Store ENASIDX at room temperature between 68°F and 77°F (20°C and 25°C).

• Keep ENASIDX in its original container.