Ivosidenib

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

Ivosidenib is only for 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 due to other health issues.

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

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

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

Swallow the tablet whole and do not crush, chew, or break it.

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.

Drink plenty of liquids while you are taking ivosidenib.

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.

Store at room temperature away from moisture and heat.

Ivosidenib can lead to a condition known as differentiation syndrome, which impacts blood cells and can be life-threatening if not treated. This condition may happen within 1 day to 3 months after you begin taking ivosidenib.

Get medical attention immediately if you experience symptoms of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

You should not use ivosidenib if you are allergic to it.

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).

May harm an unborn baby. Use birth control and tell your doctor if you become pregnant.

Ivosidenib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

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

Do not breastfeed while using ivosidenib, and for at least 1 month after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Ivosidenib can lead to a condition called differentiation syndrome, which affects blood cells and can be life-threatening if not treated. This condition may develop within 1 day to 3 months after you begin taking ivosidenib.

Seek medical help immediately if you experience symptoms of differentiation syndrome:

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

Ivosidenib may cause serious side effects. Call your doctor right away if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (feeling like you might faint);
• 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, feeling unwell, bleeding or bruising, nausea, loss of appetite, weight loss; or
• nervous system problems—numbness, pain, tingling, weakness, burning or prickly feelings, vision or hearing issues, trouble breathing.

Your cancer treatments may be delayed or stopped permanently if you experience certain side effects.

Common side effects of ivosidenib 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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Acute Myeloid Leukemia:

500 mg orally once a dayDuration of therapy: Until disease progression or unacceptable toxicityComments:-For patients without disease progression or unacceptable toxicity, therapy should continue for at least 6 months to allow time for clinical response.-Combination regimen: Administration of this drug should start on Cycle 1 Day 1 in combination with azacitidine; the manufacturer product information for azacitidine should be consulted.Uses:-In combination with azacitidine or as monotherapy, for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by a US FDA-approved test in patients 75 years and older or who have comorbidities that preclude use of intensive induction chemotherapy-For the treatment of patients with relapsed or refractory AML with a susceptible IDH1 mutation as detected by a US FDA-approved test

Usual Adult Dose for Cholangiocarcinoma of biliary tract:

500 mg orally once a dayDuration of therapy: Until disease progression or unacceptable toxicityUse: For the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by a US FDA-approved test

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Ivosidenib can lead to a serious heart issue. Your risk might increase if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other medications may impact ivosidenib, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.