Futibatinib
Futibatinib is a targeted cancer medicine used to treat a specific type of bile duct cancer called intrahepatic cholangiocarcinoma in adults whose tumors carry certain gene changes.
🧬 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 →
📖 Futibatinib: Patient Information Guide
A plain-language walkthrough of Futibatinib — 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▾
Futibatinib is a targeted cancer medicine approved for one specific use:
- Lytgobi (oral tablet) is indicated for adults with intrahepatic cholangiocarcinoma — bile duct cancer originating inside the liver — that is unresectable (cannot be removed by surgery), locally advanced, or metastatic (spread to other areas), and that carries an FGFR2 gene fusion or rearrangement, in patients who have already received prior treatment.
- This approval is under the FDA's accelerated approval pathway, based on tumor response rates and how long responses lasted; continued approval depends on results from ongoing confirmatory trials.
⚙️How it works▾
Futibatinib is a kinase inhibitor — a medicine that blocks specific proteins called FGFR1, 2, 3, and 4 (fibroblast growth factor receptors). In some bile duct cancers, FGFR2 gene fusions or rearrangements keep these receptors permanently switched on, telling cancer cells to keep growing. Futibatinib binds permanently (covalently) to these receptors and shuts that growth signal down, reducing cancer cell survival and proliferation.
💊How it's taken▾
Lytgobi is taken as oral tablets once daily, with or without food, at roughly the same time each day. Tablets must be swallowed whole — never crushed, chewed, split, or dissolved. Treatment continues until the disease progresses or side effects become unacceptable.
- If a dose is missed by more than 12 hours, skip it and take the next dose at the regular time.
- If vomiting occurs after taking a dose, do not take a replacement dose — resume with the next scheduled dose.
- Your oncology team may reduce your dose if side effects occur; follow their guidance exactly.
🤒Side effects — in detail▾
Most people taking Lytgobi experience at least some side effects. The most commonly reported ones include:
- Nail changes, pain, or infections
- Muscle and joint pain
- Constipation or diarrhea
- Dry mouth, dry skin, or dry eyes
- Fatigue or weakness
- Hair loss
- Mouth sores
- Nausea, decreased appetite, or vomiting
- Palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome) — redness, pain, or peeling on the palms and soles
- Altered sense of taste
Serious reactions to watch for include vision changes (which may signal retinal detachment), signs of very high phosphate levels such as unusual calcium deposits in tissues or vessels, fever, significant bleeding, or severe liver enzyme elevations. Contact your care team promptly if any of these occur.
⚠️Warnings & precautions▾
- Eye problems (RPED): Lytgobi can cause retinal pigment epithelial detachment — a separation of layers at the back of the eye — with symptoms like blurred vision. Mandatory eye exams with OCT imaging are required before starting, every 2 months for the first 6 months, then every 3 months. Report any vision changes immediately.
- High phosphate levels and soft tissue deposits: Nearly all patients develop hyperphosphatemia (elevated blood phosphate). If left unmanaged, this can lead to calcium deposits in soft tissues, blood vessels, and organs. Phosphate is monitored throughout treatment, and a low-phosphate diet plus phosphate-lowering medicines are typically needed. Doses may be reduced or stopped based on severity.
- Embryo-fetal toxicity: Futibatinib can cause serious harm, malformations, or death to an unborn baby. Pregnancy must be ruled out before starting treatment. Effective contraception is required during treatment and for one week after the last dose — for both female patients and male patients with a pregnant or potentially pregnant partner.
🔀What it interacts with▾
Futibatinib is broken down mainly by an enzyme called CYP3A, so medicines that affect this enzyme can change how much futibatinib stays in your body:
- Strong CYP3A inhibitors (e.g., certain antifungal medicines like itraconazole): Raise futibatinib blood levels, potentially worsening side effects — avoid combining.
- Strong CYP3A inducers (e.g., rifampin, an antibiotic/antituberculosis drug): Lower futibatinib blood levels significantly, which may reduce effectiveness — avoid combining.
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: Do not use if pregnant. This medicine can cause birth defects, pregnancy loss, or fetal death. A pregnancy test is required before starting.
- Breastfeeding: Do not breastfeed during treatment or for one week after the last dose, due to potential serious harm to a nursing child.
- Contraception: Both female and male patients of reproductive potential must use effective birth control during treatment and for one week after the last dose.
- Children: Safety and effectiveness have not been established in pediatric patients.
- Older adults: Patients 65 and over have been included in studies; no significant differences in safety or effectiveness were observed compared to younger adults.
- Liver problems: Patients with cirrhosis and elevated bilirubin may have higher drug exposure and a greater risk of side effects; discuss your liver health with your doctor before starting.
- Severe kidney disease or dialysis: The effect on people with very low kidney function or on dialysis is not fully known; inform your doctor of any kidney issues.
📡Pharmacodynamics — effects in the body▾
Because futibatinib blocks FGFR signaling, it reliably raises phosphate levels in the blood — this is an expected, measurable effect of how the drug works, not an accident. Higher doses tend to cause more pronounced increases in blood phosphate, which is why monitoring and phosphate-lowering strategies are built into treatment. At doses far above the approved level, Lytgobi does not appear to cause meaningful heart rhythm changes (QTc interval prolongation).
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, futibatinib reaches peak blood levels in about 2 hours. Eating a high-fat meal slows the peak slightly but does not meaningfully change overall drug exposure, so Lytgobi can be taken with or without food. The drug is about 95% bound to proteins in the blood and has a relatively short half-life of roughly 3 hours. It is primarily broken down by liver enzymes (mainly CYP3A), with about 91% of the drug eliminated through stool and 9% through urine.
📦How to store it▾
Store LYTGOBI tablets at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).
📄 Written from Futibatinib’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 Futibatinib
145 supplements and herbal products have documented interactions with Futibatinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- 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 Futibatinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Lytgobi treating — can you explain it in plain language? ▾
Do I have to take it at a specific time of day, and does it matter if I eat first? ▾
What side effects are most people dealing with on this medicine? ▾
Why do I need eye exams while taking this medication? ▾
Is this medicine safe to take if I could get pregnant, or if my partner could? ▾
Are there any medications I should avoid while on Lytgobi? ▾
Is Futibatinib available over the counter? ▾
When was Futibatinib first available? ▾
Who makes Futibatinib? ▾
💬 Answers drafted from Futibatinib’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 Futibatinib comes
Futibatinib 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
- Lytgobi tablets are used to treat adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma that has an FGFR2 gene fusion or rearrangement
- Lytgobi tablets are taken once daily by mouth, with or without food, at approximately the same time each day
- Lytgobi tablets must be swallowed whole — do not crush, chew, split, or dissolve them
- If a Lytgobi dose is missed by more than 12 hours, or vomiting occurs after taking it, skip that dose and resume at the next scheduled time
- Continue taking Lytgobi until your doctor tells you to stop due to disease progression or unacceptable side effects
📊 Futibatinib across the U.S. market
How Futibatinib 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Futibatinib products
A representative set of FDA-listed product records for Futibatinib — 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 | ||||
| 4 mg | — | Penn Pharmaceutical Services Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 4 mg | Oral | Taiho Pharmaceutical Co., Ltd. × 2 listings | NDA | View NDC → |
| 16 mg | Oral | Taiho Pharmaceutical Co., Ltd. | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Futibatinib 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 Futibatinib — 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 Futibatinib 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 Futibatinib 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 2628190 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 2628194In current FDA listings
Look up RxCUI 2628190 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 Futibatinib 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
Futibatinib 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. Taiho Pharmaceutical Co., Ltd. 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.