Enasidenib
Enasidenib is a targeted cancer pill used to treat adults with relapsed or refractory acute myeloid leukemia (AML) that has an IDH2 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 →
Enasidenib (Idhifa) is a specialist targeted medicine for adults whose acute myeloid leukemia (AML) has an IDH2 mutation and has come back or stopped responding, and it works by blocking that faulty enzyme so leukemia cells can mature; it has been on the U.S. market since about 2017. For a leukemia drug it is usually manageable at home, and nausea, vomiting, diarrhea, poor appetite and a changed sense of taste are what people notice most. Watch for the boxed warning, differentiation syndrome, a body-wide reaction that can be fatal if untreated, and call your care team right away for fever, trouble breathing, rapid weight gain, swelling or bone pain.
Clinical pearls
- Swallow the tablet whole without chewing, splitting or crushing, once a day at about the same time, with or without food.
- Hormonal birth control may not work reliably on enasidenib, so use a non-hormonal method during treatment and for two months after.
- Blood tests run at least every two weeks early on, catching a soaring white count or tumor lysis (rapid cancer-cell breakdown).
- It raises levels of drugs like rosuvastatin and digoxin and weakens some antifungals, so every prescriber needs your full medicine list.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Enasidenib can cause differentiation syndrome, which can be fatal if not treated. It happens when leukemia cells mature quickly and trigger a serious body-wide reaction.
Symptoms can include fever, trouble breathing, fluid around the lungs or heart, rapid weight gain or swelling, swollen lymph nodes, bone pain, and liver, kidney or multi-organ problems. If it is suspected, doctors give corticosteroids and monitor your heart and circulation closely until symptoms resolve. Seek help right away if you notice any of these signs.
Patient information guide A plain-language walkthrough of Enasidenib, written from its FDA label.
What Enasidenib is used for
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Enasidenib is used for one type of blood cancer.
- Idhifa (tablet, by mouth) treats adults with relapsed or refractory acute myeloid leukemia (AML) that has an IDH2 mutation, found by an FDA-approved test.
How Enasidenib works
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Enasidenib is an IDH2 inhibitor. It blocks mutated forms of the IDH2 enzyme that are found in some AML cells. This lowers a byproduct called 2-HG and allows immature blood cells to mature. In patient blood samples, it decreased blast counts and increased mature blood cells.
Enasidenib dosage
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Idhifa is a tablet taken by mouth once a day, with or without food, at about the same time daily. Swallow it whole.
- If you vomit a dose or miss it, take it as soon as possible the same day. Then go back to your normal schedule the next day.
- Treatment generally continues until the disease worsens or side effects are too severe. People who are not worsening are usually treated for at least 6 months.
- Your doctor may pause the drug or lower the dose for side effects. Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Enasidenib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- AML with IDH2 mutation (recommended dosage)
- 100 mg taken orally once daily with or without food until disease progression or unacceptable toxicity
- For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months
- Swallow tablets whole; do not chew, split, or crush. Take about the same time each day. If a dose is vomited, missed, or not taken at the usual time, administer as soon as possible on the same day and return to the normal schedule the following day
- Differentiation syndrome
- If suspected, administer systemic corticosteroids and initiate hemodynamic monitoring
- Interrupt IDHIFA if severe pulmonary symptoms requiring intubation or ventilator support, and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids
- Resume IDHIFA when signs and symptoms improve to Grade 2 or lower
- Noninfectious leukocytosis (WBC count greater than 30 × 10^9/L)
- Initiate hydroxyurea per standard institutional practices
- Interrupt IDHIFA if leukocytosis is not improved with hydroxyurea, then resume at 100 mg daily when WBC is less than 30 × 10^9/L
- Bilirubin elevation greater than 3 times ULN sustained for ≥2 weeks without elevated transaminases or other hepatic disorders
- Reduce IDHIFA dose to 50 mg daily
- Resume at 100 mg daily if bilirubin elevation resolves to less than 2 × ULN
- Other Grade 3 or higher toxicity considered related to treatment, including tumor lysis syndrome
- Interrupt IDHIFA until toxicity resolves to Grade 2 or lower
- Resume at 50 mg daily
- May increase to 100 mg daily if toxicities resolve to Grade 1 or lower
- If Grade 3 or higher toxicity recurs, discontinue IDHIFA
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 100 mg orally once daily until disease progression or unacceptable toxicity ( 2.2 ). 2.1 Patient Selection Select patients for the treatment of AML with IDHIFA based on the presence of IDH2 mutations in the blood or bone marrow [see Indications and Usage (1.1) and Clinical Studies (14.1) ] . Information on FDA-approved tests for the detection of IDH2 mutations in AML is available at http://www.fda.gov/CompanionDiagnostics . 2.2 Recommended Dosage The recommended dosage of IDHIFA is 100 mg taken orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response. Swallow tablets whole. Do not chew, split, or crush IDHIFA tablets. Administer IDHIFA tablets orally about the same time each day. If a dose of IDHIFA is vomited, missed, or not taken at the usual time, administer the dose as soon as possible on the same day, and return to the normal schedule the following day. 2.3 Monitoring and Dosage Modifications for Toxicities Assess blood counts and blood chemistries for leukocytosis and tumor lysis syndrome prior to the initiation of IDHIFA and monitor at a minimum of every 2 weeks for at least the first 3 months during treatment. Manage any abnormalities promptly [see Adverse Reactions (6.1) ] . Interrupt dosing or reduce dose for toxicities. See Table 1 for dosage modification guidelines. Table 1: Dosage Modifications for IDHIFA-Related Toxicities *Grade 1 is mild, Grade 2 is moderate, Grade 3 is serious, Grade 4 is life-threatening. Adverse Reaction Recommended Action • Differentiation syndrome • If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring [see Warnings and Precautions (5.1) ] . • Interrupt IDHIFA if severe pulmonary symptoms requiring intubation or ventilator support, and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids [see Warnings and Precautions (5.1) ] . • Resume IDHIFA when signs and symptoms improve to Grade 2* or lower. • Noninfectious leukocytosis (white blood cell [WBC] count greater than 30 × 10 9 /L) • Initiate treatment with hydroxyurea, as per standard institutional practices.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Enasidenib side effects
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The most common side effects are:
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Elevated bilirubin (a liver-related blood test)
- Decreased appetite
- Altered sense of taste
When to get medical help
- Call your doctor right away or get emergency help for fever, trouble breathing, cough, or low oxygen. These can be signs of differentiation syndrome.
- Report fast weight gain, swelling in the arms or legs, bone pain, or swollen lymph nodes.
- Tell your care team about reduced urination or other signs of kidney or liver problems.
- Report signs of tumor lysis syndrome or a very high white blood cell count (leukocytosis). Your doctor checks for these with regular blood tests.
- Tell your doctor right away if you become pregnant or think you might be.
Enasidenib warnings and precautions
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The biggest warning is differentiation syndrome, which can be fatal. It can show up from 1 day to 5 months after starting. Treatment is corticosteroids and close monitoring. Severe cases may need hospital care, and enasidenib may be paused.
Enasidenib can also cause fetal harm. Blood counts and chemistries are checked before treatment and at least every 2 weeks for the first 3 months.
Enasidenib interactions
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Enasidenib changes how your body handles several other drugs.
- CYP1A2 and CYP2C19 substrates: levels go up, so avoid combining unless directed.
- Caffeine: its effect may be stronger, so consider cutting back.
- CYP3A substrates, including antifungals: levels go down and they may work less well.
- Hormonal birth control: may be less effective, so use a non-hormonal method.
- OATP1B1, OATP1B3 and BCRP substrates (such as rosuvastatin): levels go up, which raises toxicity risk.
- P-gp substrates (such as digoxin): levels go up, so closer monitoring is needed.
Interactions listed in the FDA-approved label
From the Enasidenib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Certain CYP1A2 substrates (including caffeine): Enasidenib is a CYP1A2 inhibitor and increases exposure of CYP1A2 substrates, which may increase the risk of adverse reactions related to the substrates; IDHIFA may increase the effect of caffeine in patients sensitive to it. Avoid concomitant use unless otherwise recommended in the substrate's Prescribing Information where minimal concentration changes may lead to serious adverse reactions. Consider reducing the frequency of caffeine intake from food and beverages in a 24 hour period.
- Certain CYP2C19 substrates: Enasidenib is a CYP2C19 inhibitor and increases exposure of CYP2C19 substrates, which may increase the risk of adverse reactions related to these substrates. Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C19 substrates where minimal concentration changes may lead to serious adverse reactions.
- Certain CYP3A substrates: Enasidenib is a CYP3A inducer and decreases exposure of CYP3A substrates, which may reduce the efficacy of the substrates. Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates where minimal concentration changes may lead to reduced efficacy.
- Anti-fungal agents that are substrates of CYP3A: Loss of antifungal efficacy is expected. Do not administer IDHIFA with these agents.
- Hormonal contraceptives: Co-administration of IDHIFA may decrease the concentrations of hormonal contraceptives. Consider alternative methods of contraception in patients receiving IDHIFA.
- Certain OATP1B1, OATP1B3, and BCRP substrates: Enasidenib is an OATP1B1, OATP1B3, and BCRP transporter inhibitor and increases exposure of these substrates, which may increase the risk of adverse reactions related to them. Avoid coadministration where minimal concentration changes may lead to serious toxicities. If it cannot be avoided, decrease the substrates' dosage(s) in accordance with the respective Prescribing Information.
- Certain P-glycoprotein (P-gp) substrates: Enasidenib is a P-gp transporter inhibitor and increases exposure of P-gp substrates, which may increase the risk of adverse reactions related to the substrates. Follow the P-gp substrates' Prescribing Information and monitor more frequently for adverse reactions related to these substrates.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Certain CYP1A2 and CYP2C19 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information ( 7.1 ). • Certain CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information ( 7.1 ). • Certain OATP1B1, OATP1B3, and BCRP Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information ( 7.1 ). 7.1 Effect of IDHIFA on Other Drugs Certain CYP1A2 Substrates Avoid concomitant use with IDHIFA unless otherwise recommended in the Prescribing Information for CYP1A2 substrates where minimal concentration changes may lead to serious adverse reactions. Consider reducing the frequency of caffeine intake from various food and beverages in a 24 hour period while taking IDHIFA because IDHIFA may increase the effect of caffeine in patients who are sensitive to it. Enasidenib is a CYP1A2 inhibitor. Concomitant use of IDHIFA increases the exposure of CYP1A2 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to the substrates. Certain CYP2C19 substrates Avoid concomitant use with IDHIFA unless otherwise recommended in the Prescribing Information for CYP2C19 substrates where minimal concentration changes may lead to serious adverse reactions. Enasidenib is a CYP2C19 inhibitor. Concomitant use of IDHIFA increases the exposure of CYP2C19 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates. Certain CYP3A substrates Avoid concomitant use with IDHIFA unless otherwise recommended in the Prescribing Information for CYP3A substrates where minimal concentration changes may lead to reduced efficacy. Do not administer IDHIFA with anti-fungal agents that are substrates of CYP3A due to expected loss of antifungal efficacy. Co-administration of IDHIFA may decrease the concentrations of hormonal contraceptives.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Enasidenib
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- There are no listed contraindications.
- Pregnancy: enasidenib can harm a fetus. Pregnancy status is verified before starting.
- Use effective contraception during treatment and for 2 months after. Women using hormonal birth control should use a non-hormonal method.
- Do not breastfeed during treatment and for 2 months after the last dose.
- Fertility may be affected in women and men.
- Children: safety and effectiveness have not been established.
- Older adults: no dose adjustment is needed for age.
What Enasidenib does in the body
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Enasidenib lowers 2-HG levels and promotes the maturation of myeloid (blood-forming) cells. In patient samples, blast counts fell and mature cell percentages rose. A study found no large change in the heart's QTc interval.
How your body processes Enasidenib
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Enasidenib is absorbed after a dose by mouth, with peak levels in about 4 hours. Levels build up slowly and reach steady state within about 29 days of daily dosing. Its half-life is about 7.9 days. It is broken down by many liver enzymes and is mostly removed in the stool, with a smaller amount in urine.
How to store Enasidenib
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Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F) . Store and dispense in the original bottle (with a desiccant canister) to protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Enasidenib
203 supplements and herbal products have documented interactions with Enasidenib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 156
- Minor · 44
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.
Enasidenib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Enasidenib — the kind of thing our pharmacy team would talk through with you at the counter.
What is enasidenib for?
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How do I take Idhifa?
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What side effects should I expect?
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What is differentiation syndrome and what should I watch for?
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Can I take other medicines or drink coffee with it?
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Is it safe in pregnancy?
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Is Enasidenib available over the counter?
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When was Enasidenib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Enasidenib on HelloPharmacist
Enasidenib forms and strengths (how it comes)
Enasidenib 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Enasidenib inactive ingredients by manufacturer.
Tablet
How this form is used
- Idhifa is used for adults with relapsed or refractory AML with an IDH2 mutation detected by an FDA-approved test.
- Idhifa is taken by mouth once daily, with or without food.
- Swallow Idhifa tablets whole. Do not chew, split or crush them.
- Take Idhifa at about the same time each day.
- If an Idhifa dose is vomited or missed, take it as soon as possible the same day, then return to the normal schedule the next day.
Enasidenib on the U.S. market: products, makers and brands
How Enasidenib 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.
1 company lists 2 Enasidenib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2017. Brand names on the directory include Idhifa; the rest are generics.
Compare Enasidenib products
A representative set of FDA-listed product records for Enasidenib — 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 | ||||
| 50 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 100 mg | Oral | Celgene Corporation | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Enasidenib NDCs →
Enasidenib side effects reported to the 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 Enasidenib — 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 Enasidenib 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.
Enasidenib FDA approval history
How Enasidenib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Enasidenib 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.
The FDA’s enforcement reports list no Enasidenib recalls since July 2021.
✅No Enasidenib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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 1940332 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1940336In current FDA listings
Look up RxCUI 1940332 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.
Enasidenib supply and shortage status
Whether Enasidenib 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.
Enasidenib brand names
Enasidenib is sold under one brand name in the FDA directory — Idhifa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Enasidenib: manufacturers and labelers
One company lists Enasidenib products with the FDA. By number of product records, the largest are Celgene Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Enasidenib drug class (RxNorm)
Enasidenib belongs to the Isocitrate Dehydrogenase 2 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.
Sources for this Enasidenib page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Celgene Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →