About AML

AML is a cancer that affects a type of white blood cell in the bone marrow called a myeloblast. Healthy myeloblasts grow into different kinds of white blood cells.

In people with AML, the myeloblasts are immature and abnormal. This means they do not grow or work like they should. Sometimes, red blood cells and platelets are abnormal too.

All of these abnormal blood cells (called blasts) can build up in the body. They crowd out healthy white blood cells, red blood cells, and platelets. When there are too many blasts and not enough healthy cells, the symptoms of AML begin to occur.

Newly diagnosed
You have not had treatment for AML. In the past, you may have had treatment for another disease of the bone marrow, such as myelodysplastic syndrome (MDS).
Relapsed
You were symptom free for a time after initial treatment, but the signs and symptoms of AML have returned.
Refractory
Your AML did not respond to initial treatment.

Types of remission

As you know, the goal of many cancer treatments is to put people with cancer into remission. With AML and other blood cancers, there are a few types of remission. Two important ones to know about are:

Complete remission (CR)
No signs of cancer are seen, and bone marrow and blood counts are normal.
Complete remission with partial hematological recovery (CRh)
No signs of cancer are seen, but certain blood counts have not completely returned to normal.

Targeted treatment

Mutations are changes in the DNA (deoxyribonucleic acid) of a cell. Mutations can play a role in the development of AML. That’s why testing for mutations helps your healthcare team understand which AML treatments may work for you.

TIBSOVO® is a type of treatment called targeted therapy. It works on cells with a mutation called an IDH1 mutation. An IDH1 mutation can cause AML because it keeps myeloblasts from becoming healthy white blood cells. Because TIBSOVO targets this mutation, it can be used to treat adults with AML with an IDH1 mutation. About 1 in 10 people with AML have an IDH1 mutation.

Because TIBSOVO is a targeted therapy, it works differently from traditional chemotherapy. Chemotherapy kills cells that divide quickly, including blast cells. Chemotherapy can affect many types of cells in the body and is typically given by infusion, usually in the hospital.

bottle with pills

TIBSOVO is an oral treatment that can help blast cells grow into healthy blood cells by inhibiting IDH1.

 
 

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