Lenvatinib
Lenvatinib is a targeted cancer medicine used to treat differentiated thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.
🧬 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 →
Lenvatinib (Lenvima) is an oral targeted cancer medicine, on the U.S. market since about 2015, that blocks the signals tumors use to grow new blood vessels and spread; specialists use it for certain thyroid, liver, kidney and uterine cancers, sometimes with pembrolizumab or everolimus. It is a demanding drug; most people notice fatigue, diarrhea, poor appetite and a hand-foot reaction (sore, red palms and soles). The one thing to watch is high blood pressure, which is very common and can be severe, so get it controlled before starting and checked regularly. Expect regular liver and kidney blood tests, and report unusual bleeding or yellowing skin or eyes right away.
Clinical pearls
- Swallow the capsules whole at a steady time each day; if a missed dose is within 12 hours of the next, skip it.
- Tell your dentist and any surgeon you take Lenvima, since it slows wound healing and can damage jaw bone.
- Have every new prescription screened for drugs that affect heart rhythm, because combining them raises the risk of a dangerous rhythm.
- Use effective birth control during treatment and for 30 days after the last dose, since it can seriously harm a developing baby.
Patient information guide A plain-language walkthrough of Lenvatinib, written from its FDA label.
What Lenvatinib is used for
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Lenvatinib is a targeted cancer medicine approved for several cancers in adults. Below are the conditions it is used to treat:
- Differentiated thyroid cancer (DTC): Lenvima treats locally recurrent or metastatic DTC that no longer responds to radioactive iodine therapy.
- Hepatocellular carcinoma (liver cancer): Lenvima is approved as a first-line treatment for unresectable (inoperable) liver cancer.
- Renal cell carcinoma (kidney cancer): Lenvima is used in combination with pembrolizumab as a first-line treatment for advanced kidney cancer. It is also used in combination with everolimus for advanced kidney cancer after one prior anti-angiogenic therapy.
- Endometrial carcinoma (uterine cancer): Lenvima is used in combination with pembrolizumab for advanced endometrial carcinoma that has specific tumor characteristics (pMMR or not MSI-H), has progressed after prior systemic therapy, and is not treatable with surgery or radiation.
How Lenvatinib works
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Lenvatinib is a kinase inhibitor — it works by blocking specific proteins called kinases that cancer cells rely on to survive and spread. Most importantly, it blocks VEGF receptors (VEGFR1, VEGFR2, and VEGFR3), which are the switches tumors use to grow new blood vessels (a process called angiogenesis). Without that blood supply, tumors struggle to grow. Lenvatinib also blocks other growth signals — including FGFR, PDGFR, KIT, and RET — that drive tumor cell division and cancer progression.
When combined with pembrolizumab (an immunotherapy), lenvatinib has been shown in laboratory studies to help activate the immune system's own cancer-fighting cells, producing greater anti-tumor activity than either drug alone. When combined with everolimus for kidney cancer, the two drugs together cut off more of the tumor's growth signals than either drug can achieve individually.
Lenvatinib dosage
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Lenvima comes as a capsule taken by mouth once daily, at the same time each day, with or without food. The capsules should be swallowed whole — never crushed or chewed. For patients who have difficulty swallowing, the capsules can be dissolved in liquid to form a suspension, or prepared for administration through a feeding tube. If you miss a dose, take it only if there are at least 12 hours before your next scheduled dose; otherwise, skip it and continue your regular schedule. Your prescriber sets your specific dose based on your cancer type, body weight (for liver cancer), kidney and liver function, and how well you tolerate the medication.
Dosing details from the FDA-approved label
From the Lenvatinib 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.
- Differentiated Thyroid Cancer (DTC)
- 24 mg orally once daily until disease progression or until unacceptable toxicity
- Severe renal impairment (creatinine clearance less than 30 mL/min) or severe hepatic impairment (Child-Pugh C): 14 mg orally once daily
- Hepatocellular Carcinoma (HCC)
- 12 mg orally once daily for patients greater than or equal to 60 kg or 8 mg orally once daily for patients less than 60 kg, until disease progression or until unacceptable toxicity
- Based on actual body weight
- Endometrial Carcinoma (EC), in combination with pembrolizumab
- 20 mg orally once daily, in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until unacceptable toxicity or disease progression
- Severe renal impairment (creatinine clearance less than 30 mL/min) or severe hepatic impairment (Child-Pugh C): 10 mg orally once daily
- Renal Cell Carcinoma (RCC), first-line treatment of advanced RCC, in combination with pembrolizumab
- 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or until unacceptable toxicity or up to 2 years
- After 2 years, LENVIMA may be administered as a single agent until disease progression or unacceptable toxicity
- Severe renal impairment (creatinine clearance less than 30 mL/min) or severe hepatic impairment (Child-Pugh C): 10 mg orally once daily
- Renal Cell Carcinoma (RCC), previously treated, in combination with everolimus
- 18 mg in combination with 5 mg everolimus orally once daily until disease progression or until unacceptable toxicity
- Severe renal impairment (creatinine clearance less than 30 mL/min) or severe hepatic impairment (Child-Pugh C): 10 mg orally once daily
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Single Agent Therapy: DTC: The recommended dosage is 24 mg orally once daily. ( 2.3 ) HCC: The recommended dosage is based on actual body weight: 12 mg orally once daily for patients greater than or equal to 60 kg or 8 mg orally once daily for patients less than 60 kg. ( 2.5 ) Combination Therapy: EC: The recommended dosage is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks. ( 2.6 ) RCC: The recommended dosage is: 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks. ( 2.4 ) 18 mg orally once daily with everolimus 5 mg orally once daily. ( 2.4 ) Modify the recommended daily dose for certain patients with renal or hepatic impairment. ( 2.8 , 2.9 ) 2.1 Patient Selection For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with LENVIMA in combination with pembrolizumab based on MMR or MSI status in tumor specimens [see Clinical Studies ( 14.4 )]. Information on FDA-approved tests for patient selection is available at: http://www.fda.gov/CompanionDiagnostics . 2. 2 Important Dosage Information Reduce the dose for certain patients with renal or hepatic impairment [see Dosage and Administration ( 2.8 , 2.9 )] . Take LENVIMA once daily, with or without food, at the same time each day [see Clinical Pharmacology ( 12.3 )] . If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration. 2. 3 Recommended Dos ag e for Differentiated Thyroid Cancer (DTC) The recommended dosage of LENVIMA is 24 mg orally once daily until disease progression or until unacceptable toxicity. 2. 4 Recommended Dosage for Renal Cell Carcinoma (RCC) F irst- L ine Treatment of Patients with Advanced RCC The recommended dosage of LENVIMA is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or until unacceptable toxicity or up to 2 years. After completing 2 years of combination therapy, LENVIMA may be administered as a single agent until disease progression or until unacceptable toxicity. Refer to the pembrolizumab prescribing information for other pembrolizumab dosing information.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Lenvatinib side effects
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Lenvatinib causes side effects in most patients — knowing what to expect can help you manage them. Common side effects include:
Common side effects
- High blood pressure (hypertension)
- Fatigue and weakness
- Diarrhea
- Decreased appetite and weight loss
- Nausea or vomiting
- Mouth sores (stomatitis)
- Hand-foot skin reaction (redness, soreness, or blistering on palms and soles)
- Hoarse or changed voice (dysphonia)
- Joint and muscle pain
- Protein in the urine (proteinuria)
When to get medical help
- Call your doctor right away if you have severe or sudden high blood pressure, severe headache, or vision changes
- Seek urgent care for chest pain, shortness of breath, or signs of a heart attack or stroke
- Tell your doctor immediately if you notice swelling, unusual bleeding, or blood in your urine or stool
- Get help right away for signs of liver problems: yellowing of skin or eyes, severe stomach pain, or dark urine
- Contact your doctor if you develop severe diarrhea that doesn't improve, or signs of dehydration
- Report any jaw pain, numbness, or loose teeth — these could be signs of osteonecrosis of the jaw
- Seek emergency care for confusion, seizures, or vision loss, which may signal a rare brain condition (RPLS)
- Tell your doctor before any surgery or dental procedure — Lenvima can impair wound healing
Serious reactions that require prompt attention include severe bleeding, liver or kidney damage, dangerous changes in heart rhythm, abnormally low calcium, and a rare brain condition (RPLS) causing confusion or seizures. Contact your care team right away if you develop any sudden or severe new symptoms.
Lenvatinib warnings and precautions
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- High blood pressure: Occurs in a large majority of patients and can become severe quickly. Blood pressure must be controlled before starting treatment and monitored throughout.
- Serious bleeding: Potentially fatal hemorrhages have occurred, including in patients with tumors near major blood vessels. Nosebleeds and blood in the urine are the most common, but severe internal bleeding has been reported.
- Heart problems: Cardiac dysfunction and arterial blood clots (including heart attack and stroke) can occur and may require stopping the drug permanently.
- Liver and kidney damage: Liver toxicity and kidney failure have been reported. Liver and kidney function must be monitored before and during treatment.
- Abnormal heart rhythm (QT prolongation): Lenvatinib can affect the heart's electrical system. Electrolyte levels and heart rhythm should be monitored, especially in high-risk patients.
- Jaw bone damage (osteonecrosis of the jaw): Has been reported. A dental exam before starting treatment is recommended, and invasive dental procedures should be avoided if possible.
- Wound healing: Lenvima must be paused at least one week before planned surgery and for at least two weeks after major surgery.
- Fetal harm: Lenvatinib can cause serious harm or death to an unborn baby. Effective contraception is required during treatment and for 30 days after the last dose.
Lenvatinib interactions
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Lenvatinib has a known interaction with drugs that affect heart rhythm. This is the key interaction to be aware of:
- QT-prolonging drugs (certain antibiotics, antifungals, heart rhythm medicines including Class Ia and III antiarrhythmics): Taking these together with lenvatinib raises the risk of a dangerous heart rhythm abnormality. Your doctor should review all your medications carefully before you start Lenvima.
Interactions listed in the FDA-approved label
From the Lenvatinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Drugs that prolong the QT interval (medicinal products with a known potential to prolong the QT/QTc interval): LENVIMA has been reported to prolong the QT/QTc interval. Avoid coadministration of LENVIMA with medicinal products with a known potential to prolong the QT/QTc interval.
Read the label’s full interactions text
7 DRUG INTERACTIONS 7.1 Drugs That Prolong the QT Interval LENVIMA has been reported to prolong the QT/QTc interval. Avoid coadministration of LENVIMA with medicinal products with a known potential to prolong the QT/QTc interval [ see Warnings and Precaution s ( 5.9 ) ] .
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 Lenvatinib
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- Pregnancy: Lenvatinib causes fetal harm based on animal studies and how it works. Do not use during pregnancy. A pregnancy test is required before starting treatment.
- Breastfeeding: Do not breastfeed during treatment or for 1 week after the last dose — the drug may pass into breast milk and harm a nursing infant.
- Contraception: Women who could become pregnant must use effective birth control during treatment and for 30 days after the last dose. Lenvatinib may also impair fertility in both men and women.
- Children: The safety and effectiveness of lenvatinib in patients under 18 have not been established.
- Severe kidney impairment: Dose adjustment is required for patients with severely reduced kidney function (creatinine clearance below 30 mL/min).
- Severe liver impairment: Dose adjustment is required for patients with severe liver impairment (Child-Pugh C).
- Dental health: Tell your dentist you are taking Lenvima. Avoid invasive dental procedures if possible; inform your care team before any planned dental surgery.
- Upcoming surgery: Inform your surgical team — Lenvima must be paused before and after surgery to reduce the risk of wound healing problems.
Lenvatinib overdose
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Because lenvatinib binds very tightly to proteins in the blood, it is not expected to be removable by dialysis in the event of an overdose. A fatal outcome involving multiple organ failure has been reported following a single very large accidental dose. If you think you or someone else has taken too much, contact emergency services or a poison control center immediately.
What Lenvatinib does in the body
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In clinical studies of patients with radioactive iodine-refractory differentiated thyroid cancer, a higher dose of lenvatinib produced a higher overall response rate (more tumors shrinking), confirming that the drug's anti-tumor effect is dose-related within the studied range. This dose-response relationship supports the importance of taking the medication as prescribed and working with your doctor on any dose adjustments.
How your body processes Lenvatinib
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After taking a Lenvima capsule by mouth, lenvatinib is absorbed and reaches peak levels in the blood within 1 to 4 hours. Food does not change the total amount absorbed, but a high-fat meal can slow absorption and delay the peak by about 2 hours. Lenvatinib binds very tightly to blood proteins (97–99%) and has a half-life of about 28 hours — meaning it takes roughly a day for the body to clear half of the drug, which supports once-daily dosing. The drug is broken down mainly by liver enzymes (CYP3A) and other processes, and is eliminated primarily through the stool (about 64%) and urine (about 25%).
How to store Lenvatinib
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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 the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Lenvatinib
71 supplements and herbal products have documented interactions with Lenvatinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 11
- Moderate · 50
- Minor · 10
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.
Lenvatinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Lenvatinib — the kind of thing our pharmacy team would talk through with you at the counter.
What cancers does Lenvima actually treat?
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Does it matter what time of day I take it, or whether I take it with food?
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What side effects are most likely, and which ones should I call my doctor about right away?
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Can I take my other medications alongside Lenvima?
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Is Lenvima safe during pregnancy or if I'm trying to have a baby?
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Do I need to do anything special before dental work or surgery?
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Is Lenvatinib available over the counter?
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When was Lenvatinib 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 Lenvatinib on HelloPharmacist
Lenvatinib forms and strengths (how it comes)
Lenvatinib 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 Lenvatinib inactive ingredients by manufacturer.
Capsule
How this form is used
- Lenvima capsules are used to treat locally recurrent or metastatic, radioactive iodine-refractory differentiated thyroid cancer (DTC) in adults
- Lenvima capsules are used for the first-line treatment of unresectable hepatocellular carcinoma (liver cancer)
- Lenvima capsules are used in combination with pembrolizumab for advanced renal cell carcinoma (first-line) and with everolimus for previously treated advanced renal cell carcinoma
- Lenvima capsules are used in combination with pembrolizumab for advanced endometrial carcinoma with specific tumor markers (pMMR or not MSI-H) after prior therapy
- Lenvima capsules should be swallowed whole once daily at the same time each day — do not crush or chew them
- Lenvima capsules can be taken with or without food
- If a Lenvima dose is missed and cannot be taken within 12 hours, skip it and resume the next dose at the regular time
- Lenvima capsules can also be dissolved in water or apple juice to make a suspension if swallowing is difficult, or prepared for feeding tube administration with water — follow your pharmacist's instructions carefully
Lenvatinib on the U.S. market: products, makers and brands
How Lenvatinib 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 8 Lenvatinib product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2015. Brand names on the directory include Lenvima; the rest are generics.
Also listed with the FDA, not a patient dose form: Kit (12) · Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Lenvatinib is used (Medicaid data)
A general measure of how commonly Lenvatinib 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 Lenvatinib 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 Lenvatinib prescribed? Of the 1,601 medications we measure, Lenvatinib ranks #1,129 by Medicaid prescriptions — more than 29% of them.
Utilization by Lenvatinib 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.
Other Lenvatinib products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 8 of 27 listed NDC products with Medicaid activity.
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 Lenvatinib, 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 8 of 27 listed Lenvatinib NDCs with Medicaid activity.
Compare Lenvatinib products
A representative set of FDA-listed product records for Lenvatinib — 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 | ||||
| 4 mg | Oral | Eisai Inc. × 3 listings | NDA | View NDC → |
| 10 mg | Oral | Eisai Inc. × 2 listings | NDA | View NDC → |
| 💊Kits | ||||
| — | — | Eisai Inc. × 3 listings | NDA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Lenvatinib NDCs →
Lenvatinib 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 Lenvatinib — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Lenvatinib are diarrhoea, hypertension, fatigue; about 88% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
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 Lenvatinib 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.
Lenvatinib FDA approval history
How Lenvatinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Lenvatinib was first approved by the FDA in 2015 (Brand: LENVIMA · Eisai Inc). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Lenvatinib 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 Lenvatinib recalls since July 2021.
✅No Lenvatinib 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 1603296 1 dose form · 2 strengths
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Dose form (SCDF) Oral Capsule RxCUI 1604344In current FDA listings
Look up RxCUI 1603296 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.
Lenvatinib supply and shortage status
Whether Lenvatinib 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.
Lenvatinib brand names
Lenvatinib is sold under one brand name in the FDA directory — Lenvima. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Lenvatinib: manufacturers and labelers
One company lists Lenvatinib products with the FDA. By number of product records, the largest are Eisai Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sources for this Lenvatinib 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. Eisai Inc. 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 →