ivosidenib

What is the most important information I should know about ivosidenib?

Ivosidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking ivosidenib.

What is ivosidenib?

Ivosidenib targets a specific gene mutation called IDH1, which can affect your bone marrow. IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of acute myeloid leukemia (AML).

Ivosidenib is for use only in adults with an IDH1 mutation. Your doctor will test you for this gene.

Ivosidenib is used to treat AML after other treatments did not work or stopped working.

Ivosidenib is also used to treat AML in adults 75 years and older who have newly-diagnosed AML and cannot use certain chemotherapy treatments because of other health problems.

Ivosidenib is also used to treat bile duct cancer that has progressed or has spread to other parts of the body (metastatic) after treatment with other medicine.

Ivosidenib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ivosidenib?

Tell your doctor if you have ever had:

• heart disease;
• long QT syndrome (in you or a family member);
• nerve problems;
• an electrolyte imbalance (such as low levels of potassium, sodium, or magnesium in your blood);
• cirrhosis or other liver disease; or
• kidney disease (or if you are on dialysis).

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I take ivosidenib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Do not change your dose or stop taking ivosidenib without your doctor's advice.

Do not take ivosidenib with foods that are high in fat, such as butter, bacon, cheese, or whole milk.

If you vomit shortly after taking ivosidenib, do not take another dose. Take your next dose as scheduled.

You may need medical tests to check your heart function.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not take two doses within 12 hours.

What happens if I overdose?

What should I avoid while taking ivosidenib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of ivosidenib?

Ivosidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking ivosidenib.

• fever, cough, trouble breathing;
• dizziness;
• rash;
• decreased urination;
• rapid weight gain; or
• swelling in your arms or legs.

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);
• jaundice (yellowing of the skin or eyes);
• fluid build-up around the stomach --rapid weight gain, stomach pain and bloating, trouble breathing while lying down;
• low red blood cells (anemia) --pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;
• high white blood cell counts --fever, weakness, not feeling well, bleeding or bruising, nausea, loss of appetite, weight loss; or
• nervous system problems --numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• irregular heartbeats;
• stomach pain or swelling, nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• fever, tiredness;
• low red blood cell or high white blood cell counts;
• cough, shortness of breath;
• sores in your mouth or throat;
• rash;
• abnormal liver function tests;
• muscle or joint pain; or
• swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ivosidenib?

Other drugs may affect ivosidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your pharmacist can provide more information about ivosidenib.