Ivosidenib, AIVODX, Ivosidenib 250 30'S Approval No. 12 L 1054/23 Expiration Date 02-1-2027

Ivosidenib, AIVODX, Ivosidenib 250mg

Manufacturer: Laos Daxiong Pharmaceutical

Introduction: Ivosidenib is the world's first approved IDH1 inhibitor. In July 2018, Ivosidenib was approved by the US FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with IDH1 mutations. In August 2021, Ivosidenib was approved by the US FDA for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with IDH1 mutations who have been previously treated.

【Drug name】

Chinese name: Ivosidenib tablets

name: Ivosidenib Tablets

Product Name: AIVODX

【Specification】

250 mg

【Indications】

AIVODX is a prescription medicine used to treat:

• Acute myeloid leukemia (AML) with isocitrate dehydrogenase-1 (IDH1) mutations:

o Adults 75 years of age or older with newly diagnosed AML or who have health conditions that prevent them from taking certain chemotherapy treatments.

o Adults with AML whose disease has relapsed or has not improved after previous treatment.

• Adults with bile duct cancer (choledochal cancer) that has spread:

o People who have received treatment previously and

o Their tumor has a certain type of abnormal IDH1 mutation

Your healthcare provider will do tests to make sure AIVODX is right for you.

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

【Recommended dosage】

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

• Do not change your dose or stop taking AIVODX without talking to your healthcare provider.

• Take AIVODX 1 time per day at approximately the same time.

• Swallow AIVODX tablets whole. Do not split, crush, or chew the tablets.

• AIVODX can be taken with or without food.

• Do not take AIVODX with a high-fat meal. Examples of high-fat meals include 2 eggs fried in butter, 2 strips of bacon, 2 slices of buttered white bread, 1 croissant with 1 slice of cheese, and 8 ounces of whole milk.

• If you vomit after taking a dose of AIVODX, do not take an extra dose. Take your next dose at your usual time.

• If you miss a dose of AIVODX or do not take it at your usual time, take it as soon as possible and at least 12 hours before your next dose. Go back to your normal schedule the next day. Do not take 2 doses of AIVODX within 12 hours.

【side effect】

AIVODX may cause serious side effects, including:

• Differentiation syndrome. Differentiation syndrome is a disorder that affects blood cells and can be life-threatening or fatal if not treated. Differentiation syndrome can occur in adults with acute myeloid leukemia (AML) as early as 1 day to 3 months after starting AIVODX. If you develop any of the following symptoms of differentiation syndrome during treatment with AIVODX, call your healthcare provider or go to the nearest hospital emergency room right away:

o fever

oCough

o trouble breathing

o Rash

o Decreased urination

o Dizziness or lightheadedness

o Rapid weight gain

o Swelling in your arms or legs

If you develop signs and symptoms of differentiation syndrome, your healthcare provider may treat you with corticosteroid medications or hydroxyurea medications and may monitor you in the hospital.

【Storage】

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

Keep AIVODX and all medicines out of the reach of children.