Gilteritinib
Gilteritinib is a targeted oral cancer medicine used to treat adults with relapsed or refractory acute myeloid leukemia (AML) that has a specific FLT3 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 ▾
Differentiation syndrome — a potentially fatal reaction — can occur in patients taking Xospata. This happens when leukemia cells mature very rapidly and trigger a severe inflammatory response throughout the body. Warning signs include fever, difficulty breathing, low blood pressure, rapid weight gain, swelling, fluid around the heart or lungs, or reduced kidney function. It can happen with or without a rise in white blood cell counts. If differentiation syndrome is suspected, it must be treated immediately with corticosteroids and close medical monitoring. Do not ignore these symptoms — contact your medical team right away.
📖 Gilteritinib: Patient Information Guide
A plain-language walkthrough of Gilteritinib — 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▾
Gilteritinib is a targeted cancer medicine approved for use in adults with a specific type of blood cancer.
- Xospata (gilteritinib) tablets are indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) whose leukemia cells carry a FLT3 mutation (FLT3-ITD or FLT3-TKD), as confirmed by an FDA-approved test. Relapsed means the cancer came back after treatment; refractory means it stopped responding to treatment.
⚙️How it works▾
Gilteritinib works by blocking a mutated protein called FLT3 (FMS-like tyrosine kinase 3). In AML with a FLT3 mutation, this protein is overactive and continuously tells leukemia cells to grow and divide. Gilteritinib latches onto FLT3 and shuts down those growth signals — slowing the spread of leukemia cells and triggering them to die through a process called apoptosis. It targets several FLT3 mutation types, including FLT3-ITD and FLT3-D835Y.
At the recommended dose, gilteritinib blocks more than 90% of FLT3 activity within 24 hours of the first dose, and this inhibition is maintained throughout treatment.
💊How it's taken▾
Xospata is taken as an oral tablet once daily, with or without food, at roughly the same time each day. The tablets must be swallowed whole — never broken or crushed. Because a response can take time, treatment for at least 6 months is generally recommended when the drug is tolerated and the disease is not progressing.
- If you miss a dose, take it as soon as you remember on the same day — but only if it is at least 12 hours before your next scheduled dose
- Never take two doses within 12 hours
- Your doctor will monitor your blood counts, liver enzymes, and heart rhythm (ECG) regularly and may adjust your dose if side effects occur
🤒Side effects — in detail▾
The most common side effects reported with Xospata include:
- Elevated liver enzymes (transaminase increases)
- Muscle and joint pain
- Fatigue or malaise
- Fever
- Mouth sores (mucositis)
- Swelling (edema)
- Skin rash
- Diarrhea, nausea, constipation, or vomiting
- Shortness of breath
- Cough
- Headache or dizziness
- Eye problems
More serious reactions — including differentiation syndrome, heart rhythm changes (prolonged QT interval), a rare brain condition called PRES, and pancreatitis — require immediate medical attention. Contact your care team right away if you develop fever with breathing difficulty, rapid weight gain, chest pain, seizures, confusion, or severe abdominal pain.
⚠️Warnings & precautions▾
- Differentiation syndrome (boxed warning): A potentially life-threatening reaction where maturing leukemia cells trigger widespread inflammation. Signs include fever, shortness of breath, low blood pressure, rapid weight gain, swelling, and reduced kidney function. It can occur any time from day one to months into therapy. Requires immediate treatment with corticosteroids and close monitoring.
- Prolonged QT interval: Xospata can affect heart electrical conduction, which in rare cases could lead to a dangerous arrhythmia. ECGs are required before and during treatment. Low potassium or magnesium worsens this risk and must be corrected.
- Posterior reversible encephalopathy syndrome (PRES): A rare brain condition causing seizures and altered mental status. If PRES is confirmed, Xospata must be permanently stopped.
- Pancreatitis: Inflammation of the pancreas occurred in about 4% of patients in trials. Report severe stomach pain promptly. Xospata will be paused and the dose reduced if pancreatitis develops.
- Embryo-fetal toxicity: Xospata caused fetal death and birth defects in animal studies. It must not be used in pregnancy without full awareness of the risk. Effective contraception is required during and after treatment.
🔀What it interacts with▾
Gilteritinib interacts with several types of medications that affect how it is processed in the body or how other drugs work alongside it:
- Combined P-gp and strong CYP3A inducers (e.g., rifampin): Dramatically lower gilteritinib levels in the blood, potentially making Xospata less effective. Avoid this combination.
- Strong CYP3A inhibitors (e.g., itraconazole): Can nearly double gilteritinib exposure, raising the risk of side effects. Ask your doctor about alternatives; if unavoidable, you'll be monitored more closely.
- Moderate CYP3A inhibitors (e.g., fluconazole): Can moderately increase gilteritinib levels; use with awareness and medical guidance.
- Antidepressants targeting 5HT2B or sigma receptors (e.g., escitalopram, fluoxetine, sertraline): Gilteritinib may reduce how well these drugs work. Avoid the combination unless considered essential by your doctor.
- P-gp, BCRP, or OCT1 substrate drugs: Gilteritinib can raise the blood levels of drugs using these transport proteins, potentially increasing their side effects. Dose adjustments of those drugs may be needed.
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▾
- Allergy: Do not take Xospata if you have had a serious allergic reaction (including anaphylaxis) to gilteritinib or any of its ingredients.
- Pregnancy: Xospata can cause serious fetal harm. A pregnancy test is recommended within 7 days before starting treatment. Tell your doctor immediately if you become pregnant during therapy.
- Breastfeeding: Do not breastfeed during treatment or for 2 months after the last dose — the drug and/or its breakdown products may pass into breast milk and harm a nursing infant.
- Contraception: Women of childbearing potential must use effective birth control during treatment and for 6 months after stopping. Men with partners who could become pregnant must use contraception during treatment and for 4 months after stopping.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Older adults: No meaningful differences in safety or effectiveness were seen in patients aged 65 and older compared to younger patients in clinical trials.
- Liver or kidney impairment: Mild to moderate impairment does not meaningfully affect gilteritinib levels; however, the effect of severe hepatic or severe renal impairment is not known — discuss with your doctor.
- Heart rhythm concerns: Tell your doctor about any history of heart rhythm problems or if you take other medicines that can affect the QT interval.
📡Pharmacodynamics — effects in the body▾
At the recommended dose, Xospata achieves more than 90% inhibition of FLT3 phosphorylation — the process by which the FLT3 protein activates cancer cell growth — within 24 hours of the first dose, and this blockade is maintained throughout treatment. Xospata can also affect heart electrical activity: it has been associated with a small lengthening of the QT interval (the time it takes the heart to reset between beats), though large increases were not observed at the standard dose in clinical trials. A small percentage of patients (about 1.3% at the standard dose) developed a QTcF value above 500 milliseconds, which requires dose adjustment.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, gilteritinib reaches peak blood levels roughly 4 to 6 hours later when taken on an empty stomach; a high-fat meal slightly delays peak levels by about 2 hours and modestly reduces the peak concentration, though total exposure is only minimally affected. The drug has a long half-life of about 113 hours (nearly 5 days), and it takes approximately 15 days of once-daily dosing to reach steady, stable levels in the blood — with about a 10-fold accumulation over time. Gilteritinib is about 94% bound to plasma proteins and is mainly broken down by the liver enzyme CYP3A4; most of the drug and its metabolites leave the body through the stool (about 65%), with a smaller portion excreted in urine (about 16%).
📦How to store it▾
Store XOSPATA tablets at 20ºC to 25ºC (68°F to 77°F); excursions permitted between 15ºC to 30ºC (59°F to 86°F) . Keep in original container until dispensed. Protect from light, moisture and humidity.
📄 Written from Gilteritinib’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 Gilteritinib
144 supplements and herbal products have documented interactions with Gilteritinib 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 · 103
- Minor · 38
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 Gilteritinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Xospata supposed to do for my leukemia? ▾
How and when should I take my Xospata tablet? ▾
What side effects should I expect, and which ones should make me call my doctor right away? ▾
I've heard about something called 'differentiation syndrome' — what is it and will I get it? ▾
Can I take my other medications while on Xospata? ▾
Is Xospata safe if I'm pregnant or thinking about having children? ▾
Is Gilteritinib available over the counter? ▾
When was Gilteritinib first available? ▾
Who makes Gilteritinib? ▾
💬 Answers drafted from Gilteritinib’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 Gilteritinib comes
Gilteritinib 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
- Xospata tablets are used to treat adults with relapsed or refractory acute myeloid leukemia (AML) that has a FLT3 mutation confirmed by an FDA-approved test
- Xospata tablets are taken by mouth once daily, with or without food, at about the same time each day
- Swallow Xospata tablets whole — do not break or crush them
- If a Xospata dose is missed, take it as soon as possible on the same day, but at least 12 hours before the next scheduled dose; never take two doses within 12 hours
- Treatment with Xospata should continue for at least 6 months if tolerated, as a response may take time; follow your prescriber's guidance on duration
📊 Gilteritinib across the U.S. market
How Gilteritinib 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.
📈 How widely Gilteritinib is used
A general measure of how commonly Gilteritinib 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 Gilteritinib 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 Gilteritinib prescribed? Of the 1,597 medications we measure, Gilteritinib ranks #1,417 by Medicaid prescriptions — more than 11% of them.
Utilization by Gilteritinib 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.
gilteritinib 40 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 2105811
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 Gilteritinib, 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 Gilteritinib NDCs with Medicaid activity.
🔍 Compare Gilteritinib products
A representative set of FDA-listed product records for Gilteritinib — 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 | ||||
| 40 mg | — | Astellas Pharma Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 40 mg | Oral | Astellas Pharma US, Inc. × 4 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Gilteritinib 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 Gilteritinib — 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 Gilteritinib 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 Gilteritinib 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 2105806 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 2105810In current FDA listingsClinical drug / strength (SCD) 40 MGRxCUI 2105811
Look up RxCUI 2105806 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 Gilteritinib 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
Gilteritinib belongs to the Other protein kinase 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. Astellas Pharma US, 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.