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About MDS

WHAT ARE MYELODYSPLASTIC SYNDROMES (MDS)?

Your bone marrow is responsible for producing immature blood cells that mature into specialized cells such as red blood cells, white blood cells, and platelets. These specialized cells transport oxygen, help fight infections, and assist in blood clotting.

MDS are a group of blood cancers that disrupt this important process. In patients with MDS, immature blood cells do not mature into healthy red blood cells, white blood cells, or platelets like they should. As more and more immature blood cells are produced, they prevent healthy cells from forming. This leads to the signs and symptoms of MDS.

MDS is closely related to acute myeloid leukemia (AML), a more serious type of cancer that develops in about 1 in 3 people with MDS. That’s why it’s so important to treat MDS when it appears.

What are the signs and symptoms of MDS?

  • Feeling tired, dizzy, or weak
  • Shortness of breath
  • Skin that is paler than normal (which may be harder to see on darker skin tones)
  • Easily bruising or bleeding
  • Tiny purple spots on the skin
  • Frequent infections
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Targeted treatment

TREATMENT WITH TIBSOVO

TIBSOVO is the first and only FDA-approved treatment for people with relapsed or refractory MDS with IDH1 mutations

Historically, people who relapse from or do not respond to MDS treatment have had limited options.

TIBSOVO provides a treatment option for people like these

500 mg

(2x 250-mg film-coated tablets)

TIBSOVO® (ivosidenib tablets) 250 mg. TIBSOVO® (ivosidenib tablets) 250 mg.

Tablets not shown at actual size.

TIBSOVO® (ivosidenib tablets) pill bottle.

Doctors may use terms like “relapsed” or “refractory” to describe the type of MDS that TIBSOVO is used for

  • Relapsed MDS means that after reaching remission with initial treatment, the signs and symptoms of MDS have returned
  • Refractory MDS means that the disease has not responded to treatment

What are isocitrate dehydrogenase-1 (IDH1) mutations?

Mutations are changes in the DNA (deoxyribonucleic acid) of a cell. IDH1 mutations play an important role in the development of MDS because they may prevent immature blood cells from becoming healthy, mature ones.

IDH1 mutations can appear at any time during the course of MDS. Ask your doctor to get retested if your disease worsens or relapses.

Explore IDH1 mutation
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References: 1. Johns Hopkins Medicine. Facts about blood. https://www.hopkinsmedicine.org/health/wellness-and-prevention/facts-about-blood. Accessed July 22, 2026. 2. American Cancer Society. What are myelodysplastic syndromes (MDS)? https://www.cancer.org/cancer/types/myelodysplastic-syndrome/about/what-is-mds.html. Accessed July 16, 2026. 3. Dotson JL, Lebowicz Y. Myelodysplastic syndrome. In: StatPearls. StatPearls Publishing; 2026. Updated July 18, 2022. Accessed July 24, 2026. https://www.ncbi.nlm.nih.gov/books/NBK534126/ 4. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 5. Servier announces FDA approval of Tibsovo® (ivosidenib tablets) as first and only targeted therapy for patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible IDH1 mutation. News release. Servier Pharmaceuticals LLC; October 24, 2023. 6. Gil-Perez A, Montalban-Bravo G. Management of myelodysplastic syndromes after failure of response to hypomethylating agents. Ther Adv Hematol. 2019;10:2040620719847059. doi:10.1177/2040620719847059 7. Sekeres MA, Steensma DP. Defining prior therapy in myelodysplastic syndromes and criteria for relapsed and refractory disease: implications for clinical trial design and enrollment. Blood. 2009;114(13):2575-2580. doi:10.1182/blood-2009-06-228114 8. 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. 9. National Cancer Institute. NCI Dictionary of Cancer Terms: mutation. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mutation. Accessed July 16, 2026. 10. MedlinePlus Genetics. IDH1 gene. National Library of Medicine. https://medlineplus.gov/genetics/gene/idh1/. Accessed July 24, 2026. 11. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes V.2.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed January 5, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. 12. Platzbecker U, Kubasch AS, Homer-Bouthiette C, Prebet T. Current challenges and unmet medical needs in myelodysplastic syndromes. Leukemia. 2021;35(8):2182-2198. doi:10.1038/s41375-021-01265-7 13. Thol F, Weissinger EM, Krauter J, et al. IDH1 mutations in patients with myelodysplastic syndromes are associated with an unfavorable prognosis. Haematologica. 2010;95(10):1668-1674. doi:10.3324/haematol.2010.025494
 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with myelodysplastic syndromes (MDS) 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 common condition that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults 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 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 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 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 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 myelodysplastic syndromes (MDS) 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 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:

IMPORTANT SAFETY INFORMATION