Ivosidenib
Ivosidenib is a targeted cancer medicine used to treat certain types of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and cholangiocarcinoma (bile duct cancer) in adults who have a specific IDH1 gene mutation.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Tibsovo carries a Boxed Warning — the FDA's most serious safety alert — for a condition called differentiation syndrome, which can be fatal. This happens when the drug causes leukemia cells to rapidly mature and die off, triggering a dangerous inflammatory response throughout the body. It can affect patients being treated for AML or MDS. Watch for warning signs including fever, difficulty breathing, low oxygen levels, fluid around the lungs or heart, sudden weight gain or leg swelling, low blood pressure, and signs of kidney or liver problems. If any of these symptoms appear, medical treatment with corticosteroids (steroid medicines) and close heart and blood pressure monitoring must begin right away. Do not ignore these symptoms — contact your medical team immediately.
📖 Ivosidenib: Patient Information Guide
A plain-language walkthrough of Ivosidenib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ivosidenib is a targeted therapy approved for adults whose cancer carries a susceptible IDH1 gene mutation, confirmed by an FDA-approved test. It is available as Tibsovo tablets and treats the following conditions:
- Newly diagnosed AML (acute myeloid leukemia): Tibsovo is used in adults aged 75 or older, or those who cannot undergo intensive chemotherapy — either alone or combined with azacitidine.
- Relapsed or refractory AML: Tibsovo is used when AML has come back or has stopped responding to prior treatment.
- Relapsed or refractory MDS (myelodysplastic syndromes): Tibsovo is used when MDS has come back or stopped responding to prior treatment.
- Locally advanced or metastatic cholangiocarcinoma (bile duct cancer): Tibsovo is used for adults whose bile duct cancer has spread and who have already received prior treatment, and whose tumors carry an IDH1 mutation.
⚙️How it works▾
Many leukemia and bile duct cancer cells carry a mutation in the IDH1 gene. This mutation causes the IDH1 enzyme to malfunction and overproduce a chemical called 2-hydroxyglutarate (2-HG). High 2-HG levels block normal blood cell development, keeping cancer cells stuck in an immature, rapidly dividing state. Ivosidenib selectively binds to and inhibits the mutant IDH1 enzyme — not the normal version — which lowers 2-HG levels and allows cancer cells to mature (differentiate) into more normal cells. In studies, this led to reduced leukemia blast (immature cancer cell) counts and increased percentages of mature blood cells.
In bile duct cancer, ivosidenib targets the same mutant enzyme and has been shown to reduce 2-HG levels in tumor tissue, disrupting the signals that drive cancer growth.
💊How it's taken▾
Tibsovo is taken by mouth once daily, with or without food — but a high-fat meal should be avoided because it significantly raises peak drug levels. The tablets must be swallowed whole; do not split, crush, or chew them. For patients with AML or MDS who are not progressing, treatment continues for at least 6 months to allow time for the medicine to work.
- Take at roughly the same time each day.
- If you vomit a dose, skip it and wait for your next scheduled dose — do not double up.
- If you miss a dose, take it as soon as you remember, as long as it is at least 12 hours before your next dose.
- When Tibsovo is used for newly diagnosed AML in combination with azacitidine, azacitidine is given on a specific schedule within each 28-day cycle — follow your prescriber's full instructions for both medicines.
🤒Side effects — in detail▾
The most common side effects reported with Tibsovo include:
- Fatigue or weakness
- Diarrhea, nausea, vomiting, or stomach pain
- Decreased appetite
- Swelling (edema) in the limbs or body
- Joint pain (arthralgia) and muscle aches
- Shortness of breath
- Rash or itching
- QT prolongation (a heart rhythm change seen on ECG)
- Low blood cell counts (anemia, low white cells, low platelets)
- Abnormal liver or kidney lab values
More serious reactions — including differentiation syndrome, dangerous heart rhythm changes, and Guillain-Barré syndrome (nerve weakness) — require immediate medical attention and are described in the warnings section.
⚠️Warnings & precautions▾
- Differentiation syndrome (boxed warning): This potentially fatal reaction occurs when cancer cells mature and die off rapidly, causing fever, sudden weight gain, swelling, low blood pressure, difficulty breathing, and possible organ failure. It can start as early as day one or as late as three months into treatment. Seek emergency care immediately if any of these symptoms appear — treatment with corticosteroids must begin right away, and the medicine may need to be paused.
- QT interval prolongation (heart rhythm change): Tibsovo can lengthen the electrical recharge time in the heart, raising the risk of dangerous arrhythmias (abnormal heart rhythms), including ventricular fibrillation. Regular ECGs are required before and throughout treatment. Many other medicines can worsen this effect. Tell your doctor about every medicine you take.
- Guillain-Barré syndrome: A rare but serious nerve condition causing weakness, numbness, tingling, or breathing difficulty. If diagnosed, Tibsovo must be permanently stopped.
- Leukocytosis (very high white blood cell counts): Can occur and may require additional treatment such as hydroxyurea. Your care team will monitor blood counts regularly.
🔀What it interacts with▾
Ivosidenib is processed mainly through a liver enzyme called CYP3A4, and it also affects other enzymes — so several types of medicines can interact with it:
- Strong CYP3A4 inhibitors (e.g., certain antifungals, some antibiotics): Raise ivosidenib blood levels and increase the risk of heart rhythm problems. A dose reduction of Tibsovo is required if these cannot be avoided.
- Moderate CYP3A4 inhibitors: Also raise ivosidenib levels; patients need closer monitoring for QT changes.
- Strong CYP3A4 inducers (e.g., rifampin, certain seizure medicines): Lower ivosidenib levels, reducing its effectiveness. Avoid combining with Tibsovo.
- QT-prolonging drugs (certain heart medicines, fluoroquinolone antibiotics, triazole antifungals, some anti-nausea medicines): Combining with Tibsovo raises the risk of dangerous heart rhythms. Avoid when possible; if unavoidable, monitor closely.
- Antifungal medicines that are CYP3A4 substrates: Ivosidenib can reduce their levels significantly, potentially making them ineffective. Do not combine.
- Hormonal contraceptives (birth control pills, patches, rings): Ivosidenib may reduce their effectiveness; use alternative contraception during treatment.
- High-fat meals: Significantly increase peak ivosidenib exposure; avoid taking Tibsovo with high-fat food.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Ivosidenib can cause fetal harm based on animal studies. Tell your doctor immediately if you are pregnant or become pregnant while taking Tibsovo.
- Breastfeeding: Do not breastfeed during treatment or for 1 month after the last dose — the drug's effects on a nursing infant are unknown.
- Children: The safety and effectiveness of Tibsovo in pediatric patients have not been established.
- Heart conditions: People with a history of long QT syndrome, congestive heart failure, or electrolyte abnormalities (low potassium or magnesium) need more frequent heart monitoring.
- Severe kidney impairment (eGFR below 30 mL/min) or dialysis: The safety of Tibsovo in these patients is unknown; your doctor will weigh risks and benefits carefully.
- Severe liver impairment (Child-Pugh C): Safety data are lacking; your doctor will assess the risks before starting treatment.
- Mild or moderate kidney or liver problems: No starting dose adjustment is needed, but your doctor will monitor you.
- Older adults: Most patients in clinical studies were 65 or older; no overall differences in safety or effectiveness were found compared to younger patients.
📡Pharmacodynamics — effects in the body▾
Tibsovo consistently lowers 2-hydroxyglutarate (2-HG) — the abnormal chemical produced by mutant IDH1 — in both the blood and the bone marrow. In patients with blood cancers, average 2-HG reductions in the bone marrow exceeded 93%; in bile duct cancer tumor tissue, reductions averaged about 82%. Tibsovo also affects the heart's electrical system: it lengthens the QT interval (the time between heartbeats) in a dose-related way, which is why regular ECG monitoring is required throughout treatment.
🔬Pharmacokinetics — how your body processes it▾
After taking a Tibsovo tablet, peak blood levels are typically reached within 2 to 3 hours. Eating a high-fat meal significantly increases peak drug exposure, which is why it should be avoided. The drug is heavily bound to proteins in the blood (92–96%) and is broken down mainly by the liver enzyme CYP3A4. It has a long half-life — the time for blood levels to fall by half — ranging from roughly 58 to 129 hours depending on the condition being treated, meaning the medicine stays active in the body for days. Ivosidenib is cleared primarily through the feces (about 77%), with a smaller amount exiting through the urine (about 17%). Steady blood levels are generally reached within 14 days of daily dosing.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .
📄 Written from Ivosidenib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Ivosidenib
162 supplements and herbal products have documented interactions with Ivosidenib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 115
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ivosidenib — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need a genetic test before starting this medicine? ▾
What is differentiation syndrome, and how will I know if I have it? ▾
Can I take my other medications while on Tibsovo? ▾
Does it matter when I take it or what I eat? ▾
Is it safe to get pregnant or breastfeed while taking this medicine? ▾
Why do I need so many ECGs (heart tracings) during treatment? ▾
Is Ivosidenib available over the counter? ▾
When was Ivosidenib first available? ▾
Who makes Ivosidenib? ▾
💬 Answers drafted from Ivosidenib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ivosidenib comes
Ivosidenib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Tibsovo tablets are used to treat newly diagnosed AML in adults 75 or older, or those who cannot tolerate intensive chemotherapy, with a susceptible IDH1 mutation — alone or in combination with azacitidine.
- Tibsovo tablets are used to treat relapsed or refractory AML (AML that has returned or stopped responding) in adults with a susceptible IDH1 mutation.
- Tibsovo tablets are used to treat relapsed or refractory myelodysplastic syndromes (MDS) in adults with a susceptible IDH1 mutation.
- Tibsovo tablets are used to treat previously treated, locally advanced or metastatic cholangiocarcinoma (bile duct cancer) in adults with an IDH1 mutation.
- Tibsovo tablets are taken by mouth once daily, with or without food — but avoid high-fat meals.
- Swallow Tibsovo tablets whole; do not split, crush, or chew them.
- If a Tibsovo dose is vomited, do not take a replacement dose; wait for the next scheduled dose. If a dose is missed, take it as soon as possible, provided it is at least 12 hours before the next scheduled dose.
- Take Tibsovo at approximately the same time each day and follow your prescriber's instructions for the duration of treatment.
📊 Ivosidenib across the U.S. market
How Ivosidenib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ivosidenib is used
A general measure of how commonly Ivosidenib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ivosidenib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ivosidenib prescribed? Of the 1,596 medications we measure, Ivosidenib ranks #1,401 by Medicaid prescriptions — more than 12% of them.
Utilization by Ivosidenib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ivosidenib 250 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2049878
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ivosidenib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Ivosidenib NDCs with Medicaid activity.
🔍 Compare Ivosidenib products
A representative set of FDA-listed product records for Ivosidenib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 250 mg | Oral | Agios Pharmaceuticals, Inc. | NDA | View NDC → |
| 250 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 250 mg | Oral | Servier Pharmaceutical LLC × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Dottikon Exclusive Synthesis Ag | BULK INGREDIENT | View NDC → |
| 0.5 kg/kg | — | Hovione Farmaciencia Sa | DRUG FOR FURTHER PROCESSING | View NDC → |
| 0.5 kg/kg | — | Hovione Llc | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Ivosidenib NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ivosidenib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ivosidenib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ivosidenib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2049873 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 2049877In current FDA listingsClinical drug / strength (SCD) 250 MGRxCUI 2049878
Look up RxCUI 2049873 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Ivosidenib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ivosidenib belongs to the Isocitrate Dehydrogenase 1 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Servier Pharmaceutical LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.