Pexidartinib
Pexidartinib is a targeted kinase inhibitor used to treat symptomatic tenosynovial giant cell tumor (TGCT) in adults when surgery cannot adequately address the condition.
🧬 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 ▾
Turalio can cause serious and potentially fatal liver damage, including a rare condition called vanishing bile duct syndrome, where bile ducts inside the liver are destroyed. This risk exists even when liver function is monitored closely and even if the drug is stopped as soon as problems are detected. Liver tests must be done before starting Turalio and regularly throughout treatment. Depending on how severe the liver problem is, the dose may need to be reduced or the drug stopped permanently. Because of this serious risk, Turalio is only available through a restricted safety program called the Turalio REMS Program — your prescriber, pharmacy, and you must all be enrolled to receive this medication. Watch for signs of liver trouble such as yellowing of the skin or eyes, severe itching, dark urine, or unusual fatigue, and report them to your doctor immediately.
📖 Pexidartinib: Patient Information Guide
A plain-language walkthrough of Pexidartinib — 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▾
Pexidartinib is a targeted kinase inhibitor approved for a specific tumor condition in adults.
- Turalio is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) — a rare tumor of the joint lining — when it causes severe functional limitations or significant morbidity and is not amenable to improvement with surgery.
⚙️How it works▾
Pexidartinib works by blocking proteins called tyrosine kinases — specifically CSF1R, KIT, and a mutated form of FLT3. In TGCT, overactivation of the CSF1R signaling pathway causes abnormal cells to multiply and accumulate in the synovium (the tissue lining joints and tendons), forming the tumor. By blocking CSF1R, pexidartinib interferes with this process, reducing abnormal cell growth and buildup in affected joints.
💊How it's taken▾
Turalio is taken as oral capsules twice a day, always with a low-fat meal. High-fat meals significantly increase absorption and must be avoided. Capsules must be swallowed whole — not opened, broken, or chewed. If a dose is missed or vomited, take the next dose at its normal scheduled time rather than doubling up.
- Patients with mild to severe kidney impairment require a lower dose
- Patients with moderate liver impairment also require a lower dose
- Certain interacting medications (see interactions) may require further dose adjustments
🤒Side effects — in detail▾
The most commonly reported side effects with Turalio include:
- Increased LDH (lactate dehydrogenase) on blood tests
- Elevated liver enzymes (AST, ALT, ALP) on blood tests
- Hair color changes
- Fatigue or weakness
- Eye swelling (periorbital edema)
- Altered taste (dysgeusia)
- Rash or skin changes
- Low neutrophil (white blood cell) and lymphocyte counts
- Elevated cholesterol levels
- Nausea or vomiting
Serious reactions — including significant liver injury, jaundice (yellowing of skin or eyes), severe itching, and dark urine — require immediate medical attention and may lead to dose reduction or permanent discontinuation.
⚠️Warnings & precautions▾
- Serious liver injury: Turalio can cause life-threatening liver damage, including vanishing bile duct syndrome (destruction of bile ducts inside the liver). This can occur even with monitoring and prompt drug discontinuation. Liver tests must be done before starting and at regular intervals throughout treatment.
- REMS Program: Because of the liver injury risk, Turalio is only dispensed through the Turalio REMS Program. Prescribers, pharmacies, and patients must all be registered. Contact 1-833-887-2546 or www.TURALIOREMS.com for more information.
- Embryo-fetal toxicity: Turalio can cause birth defects and pregnancy loss. Effective non-hormonal contraception is required during treatment and for 1 month after stopping (for women) or 1 week after stopping (for male partners).
- High-fat meals: Eating a high-fat meal with Turalio significantly raises drug levels and may increase the risk and severity of side effects, including liver injury. Always take with a low-fat meal.
🔀What it interacts with▾
Pexidartinib interacts with several medications and foods that can raise or lower its levels in the blood, or that it can affect in turn:
- Strong or moderate CYP3A inhibitors (e.g., itraconazole, fluconazole, grapefruit juice) — increase pexidartinib levels, potentially raising the risk of side effects; dose reduction may be needed if these cannot be avoided
- Strong CYP3A inducers (e.g., rifampicin, St. John's Wort) — lower pexidartinib levels and may reduce its effectiveness; avoid combining
- UGT inhibitors (e.g., probenecid) — raise pexidartinib levels; dose reduction may be needed
- Proton pump inhibitors (e.g., omeprazole, esomeprazole) — significantly reduce pexidartinib absorption; avoid PPIs and use antacids or H2-receptor antagonists as alternatives, with careful timing
- Hormonal contraceptives — pexidartinib can make them less effective; switch to non-hormonal contraception
- Sensitive CYP3A substrates — pexidartinib lowers levels of drugs metabolized by CYP3A, which could reduce their effectiveness; avoid combining where small changes in drug level matter
- Other hepatotoxic products — combining with other drugs known to cause liver injury raises risk; avoid in patients with already-elevated liver tests or active liver disease
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▾
- Liver disease: Turalio is not recommended if you have active liver or biliary tract disease or significantly elevated liver tests at baseline; moderate liver impairment requires a dose reduction
- Kidney disease: Mild, moderate, or severe kidney impairment requires a dose adjustment
- Pregnancy: Turalio can cause fetal harm including malformations and pregnancy loss — a pregnancy test is required before starting; avoid pregnancy during treatment and for 1 month after the final dose
- Breastfeeding: Do not breastfeed during treatment or for at least 1 week after the final dose
- Fertility: Based on animal studies, pexidartinib may impair fertility in both men and women
- Children: Safety and effectiveness have not been established in patients under 18
- Older adults: Clinical trials did not include enough patients over 65 to determine whether they respond differently
- All medications and supplements: Tell your prescriber about every medication, supplement, and herbal product you take, especially antifungals, antibiotics, heartburn drugs, and St. John's Wort
🚑If you take too much▾
There is limited specific information about what to expect from a Turalio overdose. Because pexidartinib binds very strongly to proteins in the blood (greater than 99%), it is not expected to be removable by dialysis. If you suspect an overdose, contact a poison control center or seek emergency care immediately.
📡Pharmacodynamics — effects in the body▾
Higher blood levels of pexidartinib are associated with a greater risk of elevated liver enzymes (ALT and AST), meaning the drug's liver effects are dose-related. At twice the recommended exposure level, Turalio does not cause clinically meaningful changes in heart rhythm (specifically, it does not significantly prolong the QTc interval — a measure of electrical activity in the heart).
🔬Pharmacokinetics — how your body processes it▾
After taking Turalio by mouth, pexidartinib reaches peak blood levels in about 2.5 hours and takes roughly 7 days to reach a stable steady-state level in the body. It has a half-life of about 26–27 hours, meaning it takes about that long for half of the drug to be cleared. Pexidartinib is broken down mainly by liver enzymes (CYP3A4 and UGT1A4) and is eliminated mostly through the stool (about 65%) and urine (about 27%). Food significantly affects absorption — a high-fat meal can double the amount of drug absorbed compared to taking it on an empty stomach, which is why a low-fat meal is specified.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Pexidartinib’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 Pexidartinib
173 supplements and herbal products have documented interactions with Pexidartinib 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 · 131
- Minor · 36
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 Pexidartinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Turalio used for, and why did my doctor prescribe it? ▾
Why do I have to eat something before taking it, and does it matter what I eat? ▾
Why do I need all these blood tests, and how long do I need to keep getting them? ▾
What side effects should I just watch for versus which ones mean I should call someone right away? ▾
I'm on birth control pills — is that okay while taking Turalio? ▾
Are there medications or supplements I shouldn't take with Turalio? ▾
Is Pexidartinib available over the counter? ▾
When was Pexidartinib first available? ▾
Who makes Pexidartinib? ▾
💬 Answers drafted from Pexidartinib’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 Pexidartinib comes
Pexidartinib 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
- Turalio capsules are approved to treat symptomatic tenosynovial giant cell tumor (TGCT) in adults when the tumor causes severe limitations and surgery is not an adequate option
- Turalio capsules are taken twice daily by mouth with a low-fat meal (approximately 11–14 grams of total fat)
- Turalio capsules must be swallowed whole — do not open, break, or chew them
- If you miss a dose or vomit after taking Turalio, skip that dose and take the next one at its regularly scheduled time
- Avoid taking Turalio with a high-fat meal, as this raises drug levels and may increase the risk of serious side effects including liver injury
📊 Pexidartinib across the U.S. market
How Pexidartinib 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 Pexidartinib is used
A general measure of how commonly Pexidartinib 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 Pexidartinib 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 Pexidartinib prescribed? Of the 1,594 medications we measure, Pexidartinib ranks #1,460 by Medicaid prescriptions — more than 8% of them.
Utilization by Pexidartinib 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.
pexidartinib 125 MG Oral Capsule
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2626397
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 Pexidartinib, 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 Pexidartinib NDCs with Medicaid activity.
🔍 Compare Pexidartinib products
A representative set of FDA-listed product records for Pexidartinib — 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 | ||||
| 125 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 200 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 125 mg | Oral | Daiichi Sankyo, Inc. | NDA | View NDC → |
| 200 mg | Oral | Daiichi Sankyo, Inc. | NDA | View NDC → |
| 125 mg | Oral | Daiichi Sankyo Inc. | NDA | View NDC → |
| 200 mg | Oral | Daiichi Sankyo Inc. | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 20 kg/20 kg | — | Sterling Pharma Solutions Limited | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Pexidartinib 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 Pexidartinib — 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 Pexidartinib 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 Pexidartinib 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 2183102 1 dose form · 1 strength
-
Dose form (SCDF) Oral Capsule RxCUI 2183124In current FDA listingsClinical drug / strength (SCD) 125 MGRxCUI 2626397
Look up RxCUI 2183102 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 Pexidartinib 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
Pexidartinib belongs to the Kinase 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. Daiichi Sankyo, 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.