Tibsovo 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).

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

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

Tibsovo is used with or without azacitidine to treat newly-diagnosed AML in adults 75 years and older or who have health problems that prevent the use of certain chemotherapy treatments.

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

Tibsovo 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 Tibsovo.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

Take Tibsovo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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 Tibsovo without your doctor's advice.

Drink plenty of liquids while you are taking Tibsovo.

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

If you vomit shortly after taking Tibsovo, 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.

Usual Adult Dose for Acute Myeloid Leukemia:

500 mg orally once daily until disease progression or unacceptable toxicity; for patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response

Comments:
-NOTE: Select patients for the treatment of AML based on the presence of IDH1 mutations in the blood or bone marrow. Patients without IDH1 mutations at diagnosis should be retested at relapse because a mutation in IDH1 may emerge during therapy and at relapse.

Use: For the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test

Usual Geriatric Dose for Acute Myeloid Leukemia:

75 years or older:
500 mg orally once daily until disease progression or unacceptable toxicity; for patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response

Comments:
-NOTE: Select patients for the treatment of AML based on the presence of IDH1 mutations in the blood or bone marrow. Patients without IDH1 mutations at diagnosis should be retested at relapse because a mutation in IDH1 may emerge during therapy and at relapse.

Use: in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy

Usual Adult Dose for Cholangiocarcinoma 

500 mg orally once daily with or without food until disease progression or unacceptable toxicity

Use: For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.

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

To make sure you can safely take Tibsovo, 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.

Tibsovo 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 this medicine. Women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

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

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.

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

Tibsovo 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 Tibsovo.

Seek medical help right away if you have symptoms of differentiation syndrome:

• fever, cough, trouble breathing;

• dizziness;

• rash;

• decreased urination;

• rapid weight gain; or

• swelling in your arms or legs.

Call your doctor at once if you have:

• 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 Tibsovo 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.

Tibsovo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

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