Prescription medicine
Ivosidenib Brand names: Tibsovo
Ivosidenib (Tibsovo) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ivosidenib FDA label on DailyMed (effective December 22, 2025, Servier Pharmaceutical LLC); the NDA 211192 record on Drugs@FDA; every ivosidenib label on DailyMed.
Highlights of the record
FDA label of December 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DIFFERENTIATION SYNDROME IN AML AND MDS.
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS See full prescribing information for complete boxed warning. Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 5.1 , 6.1 ).
Used for
From the label: indications and usageTIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy ( 1.1 ).
Forms and strengths
- 250 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 20, 2018 Tibsovo, Servier; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 7, 2039 Tibsovo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,057 through July 30, 2026
What is ivosidenib used for?
From the label: indications and usageTIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy ( 1.1 ). Relapsed or refractory AML For the treatment of adult patients with relapsed or refractory AML ( 1.2 ). Relapsed or refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes ( 1.3 ). […]
Conditions named in the indications of ivosidenib's FDA labels, with every medicine labeled for each:
From other ivosidenib labelsLeukemia, lymphoma and myeloma: Relapsed or Refractory Acute Myeloid Leukemia TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an …
FDA pharmacologic class: Isocitrate Dehydrogenase 1 Inhibitor.
Source: FDA drug label (TIBSOVO), Servier Pharmaceutical LLC, effective December 22, 2025 (SPL set 65d254c0-67ad-42c4-b972-ad463b755b2d), via openFDA; the full label on DailyMed
What does the patient leaflet for ivosidenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TIBSOVO?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 acute myeloid leukemia (AML) and myelodysplastic syndromes (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 or 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. See " What are the possible side effects of TIBSOVO? " for more information about side effects.
From the patient leaflet: How should I store TIBSOVO?Store TIBSOVO at room temperature between 68°F to 77°F (20°C to 25°C). Do not remove the desiccant canister from the bottle. Keep TIBSOVO and all medicines out of the reach of children.
Source: FDA drug label (TIBSOVO), Servier Pharmaceutical LLC, effective December 22, 2025 (SPL set 65d254c0-67ad-42c4-b972-ad463b755b2d), via openFDA; the full label on DailyMed
Is there a generic for ivosidenib (Tibsovo)?
No generic ivosidenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Tibsovo tablets: the compound patent runs to August 19, 2033, and the last listed entry to June 7, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ivosidenib label say about other medicines?
The ivosidenib label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name ivosidenib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azacitidine | warnings and precautions | Of the 71 patients with newly diagnosed AML treated with TIBSOVO in combination with azacitidine in the clinical trial (Study AG120-C-009), 10 (14%) were found to have a heart-rate corrected QT interval (using Fridericia's method) (QTcF) greater than 500 msec and 15 out of 69 (22%) had an increase from baseline QTcF … |
| Dexamethasone | warnings and precautions | If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement [see Dosage and Administration (2.3) ]. |
| Hydroxyurea | warnings and precautions | Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. |
Other labels that name ivosidenib
Source: FDA drug label (TIBSOVO), Servier Pharmaceutical LLC, effective December 22, 2025 (SPL set 65d254c0-67ad-42c4-b972-ad463b755b2d), via openFDA; the full label on DailyMed
What do FAERS reports show for ivosidenib?
The FDA Adverse Event Reporting System holds 2,057 reports that list ivosidenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 207 are coded as a death and 642 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ivosidenib?
37 other medicines are given the same way (oral) and in the same FDA class as ivosidenib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other isocitrate dehydrogenase 1 inhibitors
- the pharmacologic class, with prices and generics
- Ivosidenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other