【Drug Name】

Name: AIVODX

Product Name:  Ivosidenib Tablets

【Specification】

250mg

【Indications】

AIVODX is a prescription medicine used to treat: 

• acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation in: 

  o adults with newly diagnosed AML who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments. 

  o adults with AML when the disease has come back or has not improved after previous treatment(s). 

• adults with bile duct cancer (cholangiocarcinoma) that has spread: 

  o who have already received previous treatment(s) and 

  o whose tumor has a certain type of abnormal IDH1 mutation 

Your healthcare provider will perform a test to make sure that 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 a day about the same time each day. 

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

• AIVODX can be taken with or without food. 

• Do not take AIVODX with a high-fat meal. An example of a high-fat meal includes 2 eggs fried in butter, 2 strips of bacon, 2 slices of white bread with butter, 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 additional dose. Take your next dose at your usual time. 

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

【Side Effects】

AIVODX may cause serious side effects, including: 

• Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Differentiation syndrome in adults with acute myeloid leukemia (AML) has happened as early as 1 day and up to 3 months after starting AIVODX. 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 during treatment with AIVODX: 

o fever 

o cough 

o trouble breathing 

o rash 

o decreased urination 

o dizziness or lightheadedness 

o rapid weight gain 

o swelling of your arms or legs 

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

【Storage】

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

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