The TIBSOVO® clinical study

TIBSOVO was studied in the following patients:

  • 28 adults with newly diagnosed AML who were 75 years or older or had health problems that prevented the use of certain chemotherapy treatments
  • 179 adults with relapsed or refractory AML

All patients received TIBSOVO 500 mg orally to start. They were treated with TIBSOVO until:

  • Their AML progressed, or
  • They had certain side effects so their doctor decided to stop treatment, or
  • They received a stem cell transplant

Benefits seen with TIBSOVO in newly diagnosed AML

Some people with newly diagnosed AML who had health problems that prevented the use of certain chemotherapy treatments and who received TIBSOVO were able to achieve remission

2 in 5 people

In the clinical study, about 2 in 5 people (12 out of 28) achieved CR or CRh with TIBSOVO.

Of the 12 people with newly diagnosed AML who achieved CR or CRh…

58% were in remission at 12 months after starting TIBSOVO*

*The median length of time that people stayed in remission could not be estimated in the study.

Another benefit of TIBSOVO was a reduction in the need for red blood cell or platelet transfusions

Transfusion free

41% of people (7 out of 17) became transfusion free. This means that people who needed transfusions when the study started were able to stop getting them for a period of at least 8 weeks.

55% of people (6 out of 11) who were transfusion free when they started TIBSOVO remained so for a period of at least 8 weeks.

TIBSOVO 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. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the symptoms of differentiation syndrome while taking TIBSOVO.

Benefits seen with TIBSOVO in relapsed or refractory AML

Some people with relapsed or refractory AML who received TIBSOVO were able to achieve remission

1 in 3 people

In the clinical study, about 1 in 3 people (57 out of 174) achieved CR or CRh with TIBSOVO

Of the 57 people with relapsed or refractory AML who achieved CR or CRh…

Half did so within 2 months of starting TIBSOVO (range 0.9 to 5.6 months)
All did so within 6 months of starting TIBSOVO
It is estimated that 1 in 3 were in remission for 1 year after starting TIBSOVO

Another benefit of TIBSOVO was a reduction in the need for red blood cell or platelet transfusions

Transfusion free

37% of people (41 out of 110) became transfusion free. This means that people who needed transfusions when the study started were able to stop getting them for a period of at least 8 weeks.

59% of people (38 out of 64) who were transfusion free when they started TIBSOVO remained so for a period of at least 8 weeks.

 
 

What is TIBSOVO?

TIBSOVO (ivosidenib) 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).

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. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Differentiation syndrome 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 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

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 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.

Taking TIBSOVO

  • Take TIBSOVO exactly as your healthcare provider tells you to.
  • Do not change your dose or stop taking TIBSOVO without talking to your healthcare provider.
  • Take TIBSOVO 1 time a day about the same time each day.
  • Swallow TIBSOVO tablets whole. Do not split, crush, or chew the tablet.
  • TIBSOVO can be taken with or without food. Do not take TIBSOVO with a high-fat meal.
  • If you vomit after taking a dose of TIBSOVO, do not take an additional dose. Take your next dose at your usual time.
  • If you miss a dose of TIBSOVO 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 TIBSOVO within 12 hours.

General information about the safe and effective use of TIBSOVO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take TIBSOVO for conditions for which it was not prescribed. Do not give TIBSOVO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TIBSOVO that is written for healthcare professionals.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.

 

What is TIBSOVO?

TIBSOVO (ivosidenib) is a prescription medicine used to treat adults with acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-1 (IDH1) mutation when the disease has come back or has not improved after previous treatment(s). 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. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Differentiation syndrome 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 while taking TIBSOVO