Olutasidenib
Olutasidenib is a targeted oral therapy used to treat relapsed or refractory acute myeloid leukemia (AML) 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 ▾
Rezlidhia carries a boxed warning — the FDA's most serious type of warning — for a condition called differentiation syndrome, which can be life-threatening or fatal. This reaction occurs when the drug causes leukemia cells to mature very rapidly, overwhelming the body. Symptoms include trouble breathing, fluid around the lungs or heart, kidney injury, low blood pressure, fever, and sudden weight gain. If any of these signs appear, Rezlidhia should be stopped right away and medical treatment started immediately. Most patients who experienced this in clinical trials recovered with prompt treatment.
📖 Olutasidenib: Patient Information Guide
A plain-language walkthrough of Olutasidenib — 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▾
Olutasidenib is a targeted cancer medicine approved for one indication:
- Rezlidhia (oral capsule) is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) — meaning AML that has come back or is no longer responding to other treatments — when the leukemia cells carry a susceptible IDH1 mutation confirmed by an FDA-approved diagnostic test.
⚙️How it works▾
Inside certain leukemia cells, a mutated version of the IDH1 enzyme overproduces a harmful chemical called 2-hydroxyglutarate (2-HG). High 2-HG levels block normal blood cell maturation and allow leukemia cells to multiply. Olutasidenib is a small molecule that directly binds to and inhibits this mutated IDH1 enzyme — reducing 2-HG levels and allowing leukemia cells to develop more normally. It targets only the mutated enzyme; it does not significantly affect the normal (wild-type) IDH1 enzyme or the related IDH2 enzyme.
💊How it's taken▾
Rezlidhia capsules are taken by mouth twice daily on an empty stomach — at least 1 hour before or 2 hours after eating. Try to take each dose at roughly the same time every day. Do not take two doses within 8 hours of each other. Treatment continues until the disease progresses or side effects become unacceptable; if there is no progression or serious toxicity, at least 6 months of treatment is recommended to allow time for a clinical response.
- Swallow capsules whole — never break, open, or chew them.
- If you vomit after a dose, skip it and take the next one at its scheduled time.
- If a dose is missed, take it as soon as you remember — but only if the next dose is at least 8 hours away.
🤒Side effects — in detail▾
The most commonly reported side effects (occurring in 20% or more of patients) include:
- Nausea
- Fatigue or malaise
- Joint and bone pain (arthralgia)
- Constipation
- Shortness of breath (dyspnea)
- Fever (pyrexia)
- Skin rash
- Diarrhea
- Elevated liver enzymes (transaminitis)
- Mouth sores (mucositis)
- Elevated white blood cell count (leukocytosis)
Serious reactions requiring immediate medical attention include differentiation syndrome (see Warnings) and significant liver toxicity — contact your care team right away if you notice sudden shortness of breath, unexplained weight gain, swelling, fever, yellowing of the skin or eyes, or dark urine.
⚠️Warnings & precautions▾
Differentiation syndrome is the most dangerous risk and carries a boxed warning. It can occur any time from the first day of treatment up to 18 months in. Symptoms include sudden shortness of breath, fluid around the lungs or heart, kidney injury, low blood pressure, fever, edema, and rapid weight gain. In the clinical trial, it occurred in 16% of patients and was fatal in 1%. If suspected, Rezlidhia is paused and treatment with corticosteroids is started immediately.
- Liver toxicity (hepatotoxicity) occurred in 23% of patients; grade 3 or 4 (severe) in 13%. Liver function tests are checked frequently — weekly for the first two months, then less often. Signs include fatigue, loss of appetite, upper-right belly discomfort, dark urine, and jaundice. Depending on severity, the dose may be reduced or permanently stopped.
- Patients 65 years and older had higher rates of liver toxicity and high blood pressure.
- Patients with mild or moderate hepatic impairment need closer monitoring for differentiation syndrome.
🔀What it interacts with▾
Olutasidenib is processed mainly by the CYP3A4 liver enzyme and also affects how the body handles other drugs metabolized by the same pathway:
- Strong or moderate CYP3A inducers (e.g., rifampin): Avoid using together — they significantly lower olutasidenib blood levels and may make Rezlidhia less effective.
- Sensitive CYP3A substrates: Avoid if possible — olutasidenib induces CYP3A and can lower blood levels of these drugs, reducing their effectiveness. If the combination is unavoidable, monitor closely for loss of effect.
- High-fat food: Taking Rezlidhia with a high-fat meal sharply increases drug absorption, which may raise the risk of serious side effects — always take on an empty stomach.
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: Rezlidhia may harm a fetus based on animal studies. Tell your doctor if you are pregnant or could become pregnant. Use effective contraception during treatment.
- Breastfeeding: Do not breastfeed during treatment or for 2 weeks after the last dose, as the drug may harm a nursing infant.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (65+): Higher rates of liver toxicity and high blood pressure were seen in patients 65 and older — closer monitoring may be needed.
- Liver impairment: Patients with mild or moderate hepatic impairment can use Rezlidhia but need enhanced monitoring. The appropriate dose has not been established for patients with severe hepatic impairment.
- Kidney impairment: No dose adjustment is needed for mild to moderate renal impairment. The impact of severe renal impairment or kidney failure on drug levels is not fully known.
- All medications: Tell your prescriber about every drug, supplement, and herbal product you take, especially anything that interacts with the CYP3A enzyme system.
📡Pharmacodynamics — effects in the body▾
Olutasidenib measurably reduces blood levels of 2-hydroxyglutarate (2-HG) — the harmful byproduct made by the mutated IDH1 enzyme — by about 59% within the first treatment cycle, and this reduction is maintained throughout therapy. Higher drug exposure in the body is associated with a greater probability of differentiation syndrome and severe liver toxicity. Olutasidenib also causes a small, concentration-dependent prolongation of the QT interval (a measure of heart electrical activity), which is expected to be larger when the drug is taken with food due to increased absorption.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, olutasidenib reaches peak blood levels in about 4 hours. Eating a high-fat meal dramatically increases absorption — raising peak levels by nearly 191% — which is why it must be taken on an empty stomach. The drug is about 93% bound to plasma proteins and has a long half-life of roughly 67 hours, meaning it stays in the body for several days; steady-state blood levels are reached within about 14 days of twice-daily dosing. Olutasidenib is primarily broken down by the CYP3A4 liver enzyme (about 90%), with smaller contributions from other CYP enzymes, and is eliminated mainly through the feces (about 75%) and to a lesser extent the urine (about 17%).
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .
📄 Written from Olutasidenib’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 Olutasidenib
180 supplements and herbal products have documented interactions with Olutasidenib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 137
- Minor · 37
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 Olutasidenib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this medication for — why did my doctor prescribe it? ▾
Why do I have to take it on an empty stomach? Does it really matter? ▾
What is differentiation syndrome and how will I know if I have it? ▾
What side effects should I just manage at home versus call the doctor about? ▾
I'm on several other medications. Are there any I need to worry about? ▾
Is it safe to get pregnant or breastfeed while taking this? ▾
Is Olutasidenib available over the counter? ▾
When was Olutasidenib first available? ▾
Who makes Olutasidenib? ▾
💬 Answers drafted from Olutasidenib’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 Olutasidenib comes
Olutasidenib 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.
Capsule
How this form is used
- Rezlidhia capsules are used to treat adults with relapsed or refractory acute myeloid leukemia (AML) that has a susceptible IDH1 mutation confirmed by an FDA-approved test
- Rezlidhia capsules are taken by mouth twice daily, approximately 12 hours apart, on an empty stomach — at least 1 hour before or 2 hours after a meal
- Rezlidhia capsules must be swallowed whole — do not break, open, or chew them
- If a Rezlidhia dose is vomited, skip it and wait for the next scheduled dose; do not take a replacement dose
- If a Rezlidhia dose is missed, take it as soon as possible — but only if the next dose is at least 8 hours away
📊 Olutasidenib across the U.S. market
How Olutasidenib 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 (1) — 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.
🔍 Compare Olutasidenib products
A representative set of FDA-listed product records for Olutasidenib — 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 |
|---|---|---|---|---|
| 💊Capsule | ||||
| 150 mg | Oral | Rigel Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Patheon API, Inc. | BULK INGREDIENT | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Olutasidenib 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 Olutasidenib — 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 Olutasidenib 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 Olutasidenib 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 2623641 1 dose form · 1 strength
-
Dose form (SCDF) Oral Capsule RxCUI 2623647In current FDA listingsClinical drug / strength (SCD) 150 MGRxCUI 2623648
Look up RxCUI 2623641 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 Olutasidenib 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
Olutasidenib belongs to the Isocitrate dehydrogenase (IDH) inhibitors 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. Rigel Pharmaceuticals, Inc. 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.