【Drug Name】

Name: ENASIDX

Product Name:  Enasidenib Tablets

【Specification】

100mg

【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 come back or has not improved after previous treatment(s). 

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

【Recommended Dosage】

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

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

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

• Swallow ENASIDX with 8 ounces (one cup) of water. 

• ENASIDX can be taken with or without food. 

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

• Your healthcare provider should do blood tests to check your blood counts before you start ENASIDX treatment and at a minimum of every 2 weeks for at least the first 3 months during treatment to check for side effects.

【Side Effects】

ENASIDX may cause serious side effects, including: 

ENASIDX may cause serious side effects, including: 

o Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells which may be lifethreatening or lead to death if not treated. Differentiation syndrome has happened within 10 days and up to 5 months after starting ENASIDX. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking ENASIDX: 

o fever 

o cough 

o shortness of breath 

o swelling of arms and legs 

o swelling around neck, groin, or underarm area 

o fast weight gain (greater than 10 pounds within a week) 

o bone pain 

If you develop any of these symptoms of differentiation syndrome, your healthcare provider may start you on a medicine taken by mouth or given through a vein (intravenous) called corticosteroids and may monitor you in the hospital.

The most common side effects of ENASIDX include: 

o nausea 

o vomiting 

o diarrhea 

o jaundice 

o decreased appetite 

Tell your healthcare provider if you have any changes to the color of your skin 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 develop certain side effects. 

These are not all the possible side effects of ENASIDX. 

Call your doctor for medical advice about side effects.

【Storage】

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

• Keep ENASIDX in the original container.