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The IDH1 Inhibitor with Broad Clinical Experience for patients with:

Actor portrayal.

*Claims data as of 1/2026.

Acute myeloid
leukemia (AML)

TIBSOVO® + azacitidine is a targeted treatment proven to help some adults with newly diagnosed AML live longer.
Results in AML › Possible side effects in AML › Support and resources
for people with AML ›

Myelodysplastic
syndromes (MDS)

TIBSOVO can help achieve remission for people with MDS whose disease has come back or has not improved after previous treatment.
Results in MDS › Possible side effects in MDS › Support and resources
for people with MDS ›

Cholangiocarcinoma
(CCA)

TIBSOVO has been shown to slow down disease progression in people with advanced CCA who have been previously treated.
Results in CCA › Possible side effects in CCA › Support and resources
for people with CCA ›

What is IDH1?

Find out about the IDH1 mutation and the important role it plays in the development of AML, MDS, and CCA.

Learn about IDH1 mutations

Learn about support that may help you access and afford TIBSOVO

If you have been prescribed TIBSOVO, ServierOne Patient Support Services will work with you to access treatment.

Find resources and support for TIBSOVO
References: 1. Data on file. Servier Pharmaceuticals LLC. 2. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 3. Mondesir J, Willekens C, Touat M, de Botton S. IDH1 and IDH2 mutations as novel therapeutic targets: current perspectives. J Blood Med. 2016;7:171-180. doi:10.2147/JBM.S70716 4. Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17(9):557-588. doi:10.1038/s41575-020-0310-z 5. National Cancer Institute. NCI Dictionary of Cancer Terms: IDH1 gene. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/idh1-gene. Accessed July 16, 2026.
 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with:

  • acute myeloid leukemia (AML):
    • with newly diagnosed AML treated in combination with azacitidine or alone who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments
    • when the disease has come back or has not improved after previous treatment(s)
  • myelodysplastic syndromes (MDS):
    • when the disease has come back or has not improved after previous treatment(s)
  • bile duct cancer (cholangiocarcinoma):
    • with bile duct cancer that has spread and
    • who have already received 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 common condition that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults with AML and MDS 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) before and during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint
  • 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

The most common side effects of TIBSOVO when used in adults with MDS include:

  • changes in certain kidney function tests
  • changes in certain blood cell counts
  • joint pain, back pain, or neck pain
  • decreased levels of albumin in the blood
  • changes in liver function tests
  • fatigue
  • diarrhea
  • cough
  • decreased levels of sodium in the blood
  • pain or sores in your mouth or throat
  • decreased appetite
  • muscle pain
  • decreased levels of phosphorus in the blood
  • itchy skin
  • rash

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 of 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.

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 may 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 healthcare provider 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 and MDS patients and Medication Guide.

Last update: September 2026

Information on this website is reviewed through established medical, legal, and regulatory processes to support accurate, balanced, and label-consistent communication about TIBSOVO.

 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with:

  • acute myeloid leukemia (AML):
    • with newly diagnosed AML treated in combination with azacitidine or alone who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments
    • when the disease has come back or has not improved after previous treatment(s)
  • myelodysplastic syndromes (MDS):
    • when the disease has come back or has not improved after previous treatment(s)
  • bile duct cancer (cholangiocarcinoma):
    • with bile duct cancer that has spread and
    • who have already received 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 common condition that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults with AML and MDS 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