Eisai Lenvima (lenvatinib) Monograph

Published: March 10, 2026

Lenvima (lenvatinib) is a kinase inhibitor that is indicated for the treatment of differentiated thyroid cancer (DTC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and endometrial cancer (EC), in adults. The safety and efficacy of Lenvima have not been established in children. Lenvima was first approved in 2015 for adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). It has since gone on to receive additional U.S. Food and Drug Administration (FDA) approvals.

Read on to learn more about Lenvima, including its warnings and precautions, dosage and administration information, how its generic form, lenvatinib, appears in clinical guidelines, and more.

Medication Overview:

Brand Name: Lenvima
Generic Name: Lenvatinib
Treatment for: Differentiated thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma
Manufacturer(s): Eisai
Initial FDA Approval: 2015

Indicated Condition	Indication	Age	Initial Date Approved
Differentiated Thyroid Cancer (DTC)	For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).	Adults	February 2015
Renal Cell Carcinoma	In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.	Adults	May 2016
Hepatocellular Carcinoma	For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).	Adults	August 2018
Endometrial Carcinoma	In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.	Adults	September 2019

Warnings and Precautions:

Hypertension: Control blood pressure prior to treatment and monitor during treatment. Withhold for Grade 3 hypertension despite optimal antihypertensive therapy. Discontinue for Grade 4 hypertension.
Cardiac Dysfunction: Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold or discontinue for Grade 3 cardiac dysfunction. Discontinue for Grade 4 cardiac dysfunction.
Arterial Thromboembolic Events: Discontinue following an arterial thromboembolic event.
Hepatotoxicity: Monitor liver function prior to treatment and periodically during treatment. Withhold or discontinue for Grade 3 or 4 hepatotoxicity. Discontinue for hepatic failure.
Renal Failure or Impairment: Withhold or discontinue for Grade 3 or 4 renal failure or impairment.
Proteinuria: Monitor for proteinuria prior to treatment and periodically during treatment. Withhold for two or more grams of proteinuria per 24 hours. Discontinue for nephrotic syndrome.
Diarrhea: May be severe or recurrent. Promptly initiate management for severe diarrhea. Withhold or discontinue based on severity.
Fistula Formation and Gastrointestinal Perforation: Discontinue in patients who develop Grade 3 or 4 fistula or any Grade gastrointestinal perforation.
QT Interval Prolongation: Monitor and correct electrolyte abnormalities. Withhold for QT interval greater than 500 ms or for 60 ms or greater increase in baseline QT interval.
Hypocalcemia: Monitor blood calcium levels at least monthly and replace calcium as necessary. Withhold or discontinue based on severity.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Withhold for RPLS until fully resolved or discontinue.
Hemorrhagic Events: Withhold or discontinue based on severity.
Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction: Monitor thyroid function prior to treatment and monthly during treatment.
Impaired Wound Healing: Withhold Lenvima for at least one week before elective surgery. Do not administer for at least two weeks following major surgery and until adequate wound healing. The safety of resumption of Lenvima after resolution of wound healing complications has not been established.
Osteonecrosis of the Jaw: Consider preventive dentistry prior to treatment with Lenvima. Avoid invasive dental procedures, if possible, particularly in patients at higher risk.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Dosage and Administration:

Single Agent Therapy:

DTC: The recommended dosage is 24 mg orally once daily.
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.

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.
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.
- 18 mg orally once daily with everolimus 5 mg orally once daily.

Modify the recommended daily dose for certain patients with renal or hepatic impairment.

Contraindications:

None.

Drug Interactions:

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.

Adverse Reactions:

In DTC, the most common adverse reactions (incidence ≥30%) for Lenvima are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.

In RCC:

The most common adverse reactions (incidence ≥20%) for Lenvima and pembrolizumab are fatigue, diarrhea, musculoskeletal pain, hypothyroidism, hypertension, stomatitis, decreased appetite, rash, nausea, decreased weight, dysphonia, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, hemorrhagic events, vomiting, constipation, hepatotoxicity, headache, and acute kidney injury.
The most common adverse reactions (incidence ≥30%) for Lenvima and everolimus are diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, decreased weight, hemorrhagic events, and proteinuria.

In HCC, the most common adverse reactions (incidence ≥20%) for Lenvima are hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.

In EC, the most common adverse reactions (incidence ≥20%) for Lenvima and pembrolizumab are hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, decreased weight, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysesthesia, dysphonia, and rash.

Examples of Lenvatinib in Guidelines

Systemic Therapy for Advanced Hepatocellular Carcinoma

American Society of Clinical Oncology, March 2024
“Where there are contraindications to atezo+bev or durva+treme, sorafenib, lenvatinib, or durvalumab may be offered as first-line treatment for patients with Child-Pugh class A, and ECOG PS 0–1 advanced HCC.”

Systemic Therapy for Hepatocellular Carcinoma

American Gastroenterological Association, March 2022
“In patients with HCC with preserved liver function not eligible for LRT or resection or with metastatic disease who are not candidates for treatment with atezolizumab+bevacizumab, the AGA suggests either lenvatinib or sorafenib over no systemic therapy.”

Prevention, Diagnosis, and Treatment of Hepatocellular Carcinoma

American Association for the Study of Liver Diseases, July 2025
“Patients with Child-Turcotte-Pugh A cirrhosis in whom atezolizumab plus bevacizumab and durvalumab plus tremelimumab are contraindicated should be offered first-line sorafenib or lenvatinib.”

Please note: This article is current as of May 19, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.