About AML

What is AML?

In healthy bone marrow, essential cells such as red blood cells, white blood cells, and platelets are produced. These specialized cells transport oxygen, help fight infections, and assist in blood clotting.

Acute myeloid leukemia (AML) is a cancer that disrupts this important process. AML affects a type of white blood cell in the bone marrow called a myeloblast. In people with AML, the myeloblasts are immature and abnormal. These cells do not mature or work like they should. As more and more myeloblasts are produced, they prevent healthy cells from forming and working. When there are too many myeloblasts and not enough healthy cells, the symptoms of AML begin to occur.

Types of AML

Newly diagnosed AML means you've never had AML before and don't have a clinical history of myelodysplastic syndrome (MDS).

Secondary AML (sAML) may occur in individuals who have previously experienced a hematological disorder or developed AML as a result of certain cytotoxic treatments.

Relapsed AML means you have experienced remission of AML after the initial treatment, but the signs and symptoms of the disease, including higher myeloblast counts and low blood counts, have returned.

Refractory AML means your AML has not responded to treatment.

Types of remission

The goal of all cancer treatments is to help get people with cancer into remission. With AML and other blood cancers, there are a few types of remission, including:

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

Monitor your health. No matter what stage of treatment or remission you are in, it is important to have regular follow-up visits with your healthcare provider.

HOW TREATMENT WITH TIBSOVO WORKS

Genetic mutations and targeted treatments

Genetic mutations are changes in the DNA (deoxyribonucleic acid) of a cell. Mutations can play a role in the development of AML. That is why it’s important to get tested for genetic mutations to help your healthcare team understand which AML treatments may work best for you.

TIBSOVO is a targeted therapy that works against a mutation called the IDH1 mutation. The IDH1 mutation plays an important role in the development of AML because it prevents myeloblasts from becoming healthy white blood cells.

About 1 in 10 people with AML has an IDH1 mutation.

As a targeted therapy, TIBSOVO works differently from traditional chemotherapy. Traditional chemotherapy kills cells that divide quickly, including cells in healthy tissues. It is typically given by infusion, usually in the hospital.

bottle with pills

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

How TIBSOVO works against your AML

TIBSOVO is a targeted therapy. TIBSOVO works on cells with a mutation called an IDH1 mutation. In IDH1 mutated AML, myeloblasts do not develop into fully formed, healthy white blood cells.

Bone marrow after treatment with TIBSOVO. TIBSOVO targets the mutation causing myeloblasts to remain immature. By targeting the IDH1 mutation, TIBSOVO helps the body return to normal blood cell counts.

cells

TIBSOVO is a targeted therapy. TIBSOVO works on cells with a mutation called an IDH1 mutation. In IDH1 mutated AML, myeloblasts do not develop into fully formed, healthy white blood cells.

cells cells

Bone marrow after treatment with TIBSOVO. TIBSOVO targets the mutation causing myeloblasts to remain immature. By targeting the IDH1 mutation, TIBSOVO helps the body return to normal blood cell counts.

cells cells

TIBSOVO is a nonmyelosuppressive therapy. This means that TIBSOVO does not attack normal, healthy blood cells.

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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 treated in combination with TIBSOVO and azacitidine who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments
  • 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 in AML Patients. Differentiation syndrome is a common condition, which can be serious, that affects your blood cells and may be life-threatening or lead to death. 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 when used in combination with azacitidine or alone in adults with AML include:

  • changes in certain blood cell counts
  • diarrhea
  • increased blood sugar
  • fatigue
  • changes in certain liver function tests
  • swelling of arms or legs
  • decreased levels of electrolytes in the blood
  • nausea
  • vomiting
  • decreased appetite
  • joint pain
  • shortness of breath
  • uric acid increased
  • stomach (abdominal) pain
  • changes in certain kidney function tests
  • pain or sores in your mouth or throat
  • rash
  • irregular heart rhythm or heartbeat (QTc prolongation)
  • differentiation syndrome
  • muscle pain

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 of the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 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 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 treated in combination with TIBSOVO and azacitidine 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 in AML Patients. Differentiation syndrome is a common condition, which can be serious, that affects your blood cells and may be life-threatening or lead to death. 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:

IMPORTANT SAFETY INFORMATION