What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat:

  • acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation in:
    • adults with newly diagnosed AML who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments.
    • 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:
    • who have already received previous treatment(s) and
    • whose tumor has a certain type of abnormal IDH1 mutation.

Your healthcare provider will perform a test to make sure that TIBSOVO is right for you. It is not known if TIBSOVO is safe and effective in children.

 

IMPORTANT SAFETY INFORMATION

TIBSOVO may cause serious side effects, including:

  • Differentiation Syndrome in AML Patients. 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 TIBSOVO. 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 TIBSOVO:
    • fever
    • cough
    • trouble breathing
    • rash
    • decreased urination
    • dizziness or lightheadedness
    • rapid weight gain
    • swelling of your arms and 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.

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.
  • Guillain-Barré Syndrome. Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barré syndrome, including:
    • weakness or tingling feeling in your legs, arms, or upper body
    • numbness and pain on one side or both sides of your body
    • any changes in your ability to see, touch, hear, or taste
    • burning or prickling sensation
    • difficulty breathing

The most common side effects of TIBSOVO in adults with AML include:

    • fatigue
    • joint pain
    • high white blood cell count
    • diarrhea
    • swelling of arms or legs
    • nausea
    • shortness of breath
    • pain or sores in your mouth or throat
    • irregular heart rhythm or heartbeat (QTc prolongation)
    • rash
    • cough
    • decreased appetite
    • muscle pain
    • constipation
    • fever
    • hemoglobin decreased (anemia)
    • decreased levels of electrolytes in the blood
    • changes in liver or kidney function tests

The most common side effects of TIBSOVO in adults with Cholangiocarcinoma include:

    • fatigue
    • nausea
    • abdominal pain
    • diarrhea
    • cough
    • decreased appetite
    • fluid and swelling in your stomach area
    • vomiting
    • hemoglobin decreased (anemia)
    • rash
    • changes in liver function tests

Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop certain side effects.

TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking TIBSOVO, tell your healthcare provider about all of your medical conditions, including if you:

  • have any heart problems, including a condition called long QT syndrome.
  • have problems with abnormal electrolytes, such as sodium, potassium, calcium, or magnesium levels.
  • have nervous system problems.
  • have problems with your kidneys or are on dialysis.
  • have any liver disorders, including cirrhosis.
  • are pregnant or plan to become pregnant. TIBSOVO can cause harm to your unborn baby. You should avoid becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TIBSOVO.
  • are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not breastfeed during your treatment with TIBSOVO and for at least 1 month after your last dose of TIBSOVO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work as well.

Please see Full Prescribing Information, including BOXED WARNING for AML patients and Medication Guide.

 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat:

  • acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation in:
    • adults with newly diagnosed AML who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments.
    • adults with AML when the disease has come back or has not improved after previous treatment(s).

IMPORTANT SAFETY INFORMATION

TIBSOVO may cause serious side effects,
including:

  • Differentiation Syndrome in AML Patients. 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 TIBSOVO. 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 TIBSOVO: