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For people with AML, MDS, and CCA

Commonly asked questions about TIBSOVO®

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TIBSOVO® (ivosidenib tablets)

What is TIBSOVO?

TIBSOVO is a targeted 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):
    • When the disease has spread and has been previously treated

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.

How does TIBSOVO work?

TIBSOVO works differently from chemotherapy in that it does not attack normal, healthy cells. TIBSOVO is the first treatment of its kind, a targeted therapy that works on cells with a mutation called an IDH1 mutation.

How will I take TIBSOVO?

Typically, people are prescribed to take 2 tablets once a day. You can take TIBSOVO at home without the infusion time requirements of chemotherapy.

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Side effects

What are the side effects of TIBSOVO in AML?

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

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 the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

What are the side effects of TIBSOVO in MDS?

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 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 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

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 the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

What are the side effects of TIBSOVO in CCA?

TIBSOVO may cause serious side effects, including:

  • 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 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 the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

What is differentiation syndrome?

For people with AML or MDS, differentiation syndrome is a common condition that affects your blood cells and may be life-threatening or lead to death. If you are being treated for AML or MDS, differentiation syndrome may happen 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 provide medication and may monitor you in the hospital.

How are side effects monitored?

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.

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.

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Taking and storing TIBSOVO

How do I take TIBSOVO?

TIBSOVO is an oral medication you can take at home. Take TIBSOVO exactly as your healthcare provider tells you to. Take 2 tablets orally, once a day. Taking TIBSOVO at the same time as another daily activity, like when you brush your teeth, can help you remember. Swallow TIBSOVO tablets whole. Do not split, crush, or chew the tablets.

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.

Should I take TIBSOVO with food?

Take TIBSOVO with or without food. Do not take TIBSOVO with a high-fat meal (about 1000 calories and 58 grams of fat).

What should I do if I miss a dose of TIBSOVO?

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. Do not change your dose or stop taking TIBSOVO without talking to your healthcare provider.

If you vomit after taking a dose of TIBSOVO, do not take an additional dose. Take your next dose at your usual time.

How should I store TIBSOVO?

Store TIBSOVO at room temperature from 68°F to 77°F (20°C to 25°C). Keep TIBSOVO in the original container. Keep the container tightly closed with the desiccant canister (drying agent) inside to protect the tablets from moisture. Do not remove the desiccant canister from the bottle. Keep TIBSOVO and all medicines out of reach of children.

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IDH1 mutations

What is IDH1?

IDH1 stands for isocitrate dehydrogenase-1. In healthy cells, the IDH1 gene makes the IDH1 protein, which plays a role in normal chemical reactions within cells. When the IDH1 gene is altered due to a genetic mutation, cells make an abnormal (mutated) version of the IDH1 protein. This mutated IDH1 protein may promote the development of certain types of cancers, including AML, MDS, and CCA. TIBSOVO is a targeted treatment that blocks mutated IDH1. In AML and MDS, this helps tumor cells mature normally while in CCA, this stops their growth and spread.

What is a mutation? What does it mean when IDH1 is mutated?

Mutations are changes in the DNA sequences of cells. Mutations may be caused by mistakes during cell division, or they may be caused by exposure to DNA-damaging agents in the environment. Certain mutations may lead to cancer or other diseases. When the IDH1 gene is altered due to a genetic mutation, cells make an abnormal (mutated) version of the IDH1 protein. This mutated IDH1 protein may promote the development of certain types of cancers, including AML, MDS, and CCA. TIBSOVO is a targeted treatment that blocks mutated IDH1. In AML and MDS, this helps tumor cells mature normally while in CCA, this stops their growth and spread.

How is mutated IDH1 identified?

Biomarker testing involves a sample of tissue (eg, a piece of tumor from biopsy or surgery), blood, or other body fluid being sent to the laboratory for analysis to check for certain genes, proteins, or other molecules that may be a sign of a disease or condition, such as cancer.

Your doctor may recommend biomarker testing to look for specific changes in the DNA of the cancer cells, including mutated IDH1. It may take a few weeks to get results, but the results will enable your doctor to personalize the best approach to treating your type of cancer. TIBSOVO is a treatment that your doctor may prescribe after giving you an FDA-approved test for IDH1, and it targets the IDH1 mutation in AML, MDS, and CCA.

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Additional support

Where can I go for additional support? What is ServierONE®?

ServierONE Patient Support Services will work with you, your caregiver, and your healthcare provider(s) to help you get treatment after you've been prescribed TIBSOVO.

Financial assistance may be available, no matter your insurance type or status.a

Your healthcare provider or ServierONE Patient Support Services can help figure out which financial assistance program is right for you when you're prescribed TIBSOVO.

Learn more about ServierONE

Independent foundations and patient advocacy

Independent foundations and patient advocacy organizations may also provide support to patients. For a list of organizations, click here.

Your ServierONE care manager team can provide more information about TIBSOVO. For more information and full Terms and Conditions for each program, please visit ServierONE.com or call 1‑800‑813‑5905.

aIf you are waiting for coverage, you may be eligible for a free product program. Contact ServierONE for more information.

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Learn about TIBSOVO and AML
References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 2. Popovici-Muller J, Lemieux RM, Artin E, et al. Discovery of AG-120 (ivosidenib): a first-in-class mutant IDH1 inhibitor for the treatment of IDH1 mutant cancers. ACS Med Chem Lett. 2018;9(4):300-305. doi:10.1021/acsmedchemlett.7b00421 3. American Cancer Society. Chemotherapy. https://www.cancer.org/cancer/managing-cancer/treatment-types/chemotherapy.html. Accessed July 16, 2026. 4. 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. 5. 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 6. Yang H, Ye D, Guan KL, Xiong Y. IDH1 and IDH2 mutations in tumorigenesis: mechanistic insights and clinical perspectives. Clin Cancer Res. 2012;18(20):5562-5571. doi:10.1158/1078-0432.CCR-12-1773 7. DiNardo CD, Jabbour E, Ravandi F, et al. IDH1 and IDH2 mutations in myelodysplastic syndromes and role in disease progression. Leukemia. 2016;30(4):980-984. doi:10.1038/leu.2015.211 8. National Cancer Institute. NCI Dictionary of Cancer Terms: mutation. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mutation. Accessed July 16, 2026. 9. National Cancer Institute. NCI Dictionary of Cancer Terms: biomarker testing. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/biomarker-testing. Accessed July 16, 2026. 10. National Cancer Institute. Biomarker testing for cancer treatment. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment. Accessed July 16, 2026. 11. Fox AH, Keller-Evans RB, Huang RSP, Silvestri GA. Turnaround time of comprehensive genomic profiling in lung cancer and other solid tumors. JCO Oncol Pract. Published online June 18, 2026. doi:10.1200/OP-25-01191
 

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