Welcome to Eisai Patient Support for LENVIMA^® (lenvatinib)

From understanding benefits verification to exploring financial assistance options, Eisai Patient Support (EPS) offers programs, information, and resources to help your eligible patients start and
stay on treatment. Support includes:

Benefits
Verification
Appeal
information
Prior
authorization
information
Financial
assistance
program
information

Actor Portrayal

FOR US RESIDENTS ONLY

Patient Site

For help understanding coverage, reimbursement, and patient access issues, you can request support from an Access and Reimbursement Manager (ARM).

Request support from an ARM

For more information, call Eisai Patient Support:

1-866-613-4724

Monday through Friday, 9 AM to 6 PM ET

How to Enroll Your Eligible Patients in Eisai Patient Support

EPS Offers Two Options for Enrollment

Option 1:

Send an electronic prescription for LENVIMA directly to Eisai Patient Support Pharmacy

Eisai Patient Support Pharmacy is categorized as a retail pharmacy in EMR/EHR systems and is located at:
2730 S. Edmonds Lane, #400A, Lewisville, TX 75067

NPI: 1861259194 
TX License: 35268
E-prescribe ID/NCPDP: 5942176

Eisai Patient Support Pharmacy is operated by Sonexus Health Pharmacy Services, LLC

Option 2:

Download, complete, sign, and submit an EPS Enrollment Form for your eligible patient

Download LENVIMA EPS Enrollment Form

Select all program offerings that patient should be evaluated for; complete and sign all applicable pages.

Descarga el Formulario
de Inscripción en Español

Fax completed form and both sides of the patient's insurance card(s) to:
1-855-246-5192

Download LENVIMA EPS Enrollment Form Descarga el Formulario
de Inscripción en Español

Select all program offerings that patient should be evaluated for; complete and sign all applicable pages.

Fax completed form and both sides of the patient's insurance card(s) to:
1-855-246-5192

For either enrollment option, patients can provide their signature electronically at www.LENVIMAConsent.com

Visit LENVIMAConsent.com

All support offerings are available to eligible patients regardless of enrollment option.

Eisai Patient Support Enrollment Resource

Download How to Enroll Patient Resource

Eisai Patient Support Program Offerings

EPS offers a number of different programs, including financial assistance for eligible patients. For more information on these programs, including any eligibility requirements, see below.

LENVIMA Co-pay Program

With the LENVIMA Co-pay Program, eligible, commercially insured patients could pay as little as $0 out of pocket for their prescription. This program is not available to patients enrolled in state or federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD, or TRICARE.

To enroll your commercially insured patients in the program, access the LENVIMA Co-Pay Portal at LENVIMACopay.com.
Visit LENVIMACopay.com

LENVIMA CO-PAY PROGRAM TERMS & CONDITIONS

Good toward the purchase of LENVIMA prescriptions. The LENVIMA Co-pay Program provides up to a maximum of $10,000 per year to assist with the out-of-pocket costs for LENVIMA. Depending on the insurance plan, a patient could have additional financial responsibility for any amounts over Eisai's maximum liability. No substitutions permitted. Not available to patients enrolled in state or federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD, or TRICARE. Offer only available to patients with private, commercial insurance. Not valid for LENVIMA prescriptions reimbursed in full by any third-party payer. Save this information for reuse with each prescription. May not be combined with any other discount offer. The program is not valid for cash-paying customers. Federal law prohibits the selling, purchasing, trading, or counterfeiting of this card. Void outside of USA and where prohibited by law. Eisai Inc. reserves the right to rescind, revoke, or amend this offer at any time without notice. You must be 18 years or older to use this card for yourself. Patients and pharmacies are responsible for disclosing to insurance carriers the redemption and value of the program and complying with any other conditions imposed by insurance carriers, third-party payers, and applicable law on the redemption. The value of this program is not contingent on any prior or future purchases. This program offer may not be accepted at all pharmacies. This offer is not an insurance program. No membership fees.
LENVIMA Patient Assistance Program

The LENVIMA Patient Assistance Program is for patients who need help paying for LENVIMA. This program provides LENVIMA at no cost to uninsured and financially burdened patients who meet the program eligibility criteria.

To help your patients apply for this program, you can download and complete the LENVIMA Eisai Patient Support Enrollment Form.

For more information, call Eisai Patient Support at 1-866-613-4724, Monday through Friday, 9 AM to 6 PM ET.

Download the LENVIMA EPS Enrollment Form Descargar el formulario de inscripción en español

Please note that both your signature and your patient’s signature are required to complete enrollment. Patients can sign the form directly or provide signature electronically by visiting LENVIMAConsent.com.
Visit LENVIMAConsent.com

Alternatively, you can send an electronic prescription for LENVIMA directly to Eisai Patient Support Pharmacy to facilitate enrollment into the LENVIMA Patient Assistance Program.

For more information on Eisai Patient Support Pharmacy, including address and NCPDP, click HERE.

Eisai Patient Support Pharmacy is operated by Sonexus Health Pharmacy Services, LLC

LENVIMA PATIENT ASSISTANCE PROGRAM TERMS & CONDITIONS

The LENVIMA Patient Assistance Program (''Program'') provides free drug for eligible patients who meet financial need and insurance coverage criteria. Patients must have a valid prescription for LENVIMA. Patient must be either uninsured or insured but without insurance coverage for LENVIMA (i.e., the insurer must have denied a first-level appeal of an initial coverage denial) or without enough coverage to pay for LENVIMA. Patient must have a household income equal to or less than 500 percent of the Federal Poverty Level. Patient must be a resident of the United States or Puerto Rico. Commercially insured patients and Federal health care program beneficiaries who qualify for the Program are enrolled for the entire calendar year. Uninsured patients who qualify for the Program are enrolled for a rolling 12-month period. Patients with an insurance plan, employer, or any third-party entity that requires patients to apply to a manufacturer’s patient assistance program instead of providing coverage, commonly known as Alternate Funding Programs (AFPs), are not eligible for Eisai’s Patient Assistance Program (PAP). You agree to inform Eisai Patient Support (EPS) if you are a member of such an insurance plan or if you are applying to EPS on behalf of a patient who is a member of such an insurance plan. If at any point EPS determines that a patient is enrolled or moved into an Alternate Funding Program, participation in PAP may terminate immediately and product support will be discontinued. All patients must re-enroll at the end of their respective Program approval period to ensure they continue to meet the Program's eligibility criteria. Eisai reserves the right to reassess eligibility for patients with commercial insurance during the enrollment period.

The Program will ship LENVIMA directly to the patient's home address entered on the enrollment form. Product provided through the Program may not be sold, traded, bartered, transferred, or returned for credit. If the enrolled patient is no longer on therapy or otherwise cannot use the free supply of LENVIMA, the provider agrees to promptly contact Eisai Patient Support to arrange for product return or destruction.

No patient, pharmacy, payor, or other third-party may be billed for the free drug provided pursuant to the Program. Patients and providers must not submit any claim for reimbursement for product pursuant to this Program to any third-party payor, including Medicare, Medicaid, or any other federal or state health care program. Patient cannot apply the value of the free product received through this Program toward any insurance benefit out-of-pocket spending calculations such as Medicare Part D true out-of-pocket (TrOOP) Costs. The free LENVIMA provided under the Program is not contingent on any past or future purchases of any product, under the patient's insurance benefit or otherwise. Eligibility determinations are made without regard to patient's insurance provider (if any) or choice of physician.

Patients are free to change physician at any time. The Program is not health insurance. Limitations may apply. Eisai reserves the right to rescind, revoke, or amend this Program at any time without notice. Additional terms and eligibility criteria apply. Contact Eisai Patient Support for additional information.
LENVIMA Dose Exchange Program
There may be times when you need to reduce the dose for a patient during the course of LENVIMA treatment due to an adverse reaction before the patient has finished their current supply of LENVIMA. Through the LENVIMA Dose Exchange Program, eligible patients who require a dose reduction can exchange up to 15 unused doses for the same number of doses at the reduced dose strength at no additional cost.

The program allows patients to exchange unused 20-mg doses for 14-mg doses or 10-mg doses for 8-mg doses when the HCP has directed a dose reduction based on the prescribing information.

Eligibility Criteria

To be eligible for the LENVIMA Dose Exchange Program, a patient must:

Have an eligible LENVIMA prescription (an eligible LENVIMA prescription is a prescription for 20-mg or 10-mg of LENVIMA for an FDA-approved indication) and a recommended dose reduction from 20-mg to 14-mg, or 10-mg to 8-mg

Be 18 years of age or older

Be a resident of the United States or Puerto Rico

Have at least 5 doses from a current eligible prescription

Return unused doses in the provided pre-addressed envelope and according to the instructions provided by Sonexus Health Pharmacy

To enroll your patient in the LENVIMA Dose Exchange Program, please download and complete this form and fax it, along with the patient’s prescription, to Sonexus Health Pharmacy at 1-855-246-5192.
Download the LENVIMA Dose Exchange Program Enrollment Form

For Dose Exchange Program Terms & Conditions, please click HERE.
LENVIMA Temporary Supply Program

Through the LENVIMA Temporary Supply Program, eligible patients may receive up to a 30-day supply of LENVIMA (dispensed in up to three 10-day increments) while awaiting a coverage determination from their insurance provider.

To request your patient receive LENVIMA through the Temporary Supply Program, please download and complete this form and fax it to 1-855-246-5192.
Download the LENVIMA  Temporary Supply Program Form

For Temporary Supply Program Terms & Conditions, please click HERE.

Request Support From an Access & Reimbursement Manager

How can I better understand access for patients prescribed LENVIMA?

Access & Reimbursement Managers (ARMs) support patients’ access to prescribed Eisai products by providing relevant information and addressing provider questions regarding insurance overage, coding, reimbursement, and patient access issues.

ARMs may also educate healthcare providers and their staff about EPS programs.

To request support from an ARM, please complete this short form and an ARM will contact you shortly:

Complete ARM Request Form

You can also contact Eisai Patient Support directly to request support from an ARM

Phone Call Icon Call 1-866-61-EISAI (1-866-613-4724), Monday through Friday: 9am - 6pm ET

Ordering LENVIMA

LENVIMA can be obtained in two ways:

LENVIMA is available through Specialty Pharmacies, which will mail the medication directly to patients.

LENVIMA can also be dispensed through select eligible physician offices, clinics, or hospital pharmacies.

For more information on how to obtain LENVIMA, contact these Specialty Pharmacies (simply click on the pharmacy name or call the number provided):

Information & Resources

For more information on EPS, enrollment, and for patients taking LENVIMA, the following support tools are available.

Downloadable Resources

Click on any of the following resources to download:

ACCESS, COVERAGE, AND REIMBURSEMENT

SUPPORT PROGRAMS AND PATIENT ENROLLMENT

ORDERING AND FULFILLMENT

Patient Organizations

These independent patient organizations may provide assistance to patients, including options such as educational tools, counseling and support groups.

The organizations listed are independent from Eisai. Eisai does not influence or control the operations or eligibility criteria for these independent programs. This information is provided for informational purposes only. For a comprehensive list of assistance offerings from these independent organizations, please visit their websites.

LENVIMA Treatment & Coverage

Learn more about LENVIMA, including:

Clinical data
Mechanism of Action
Safety Information
Dosing

Visit LENVIMAhcp.com

Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services
must be medically appropriate and properly supported in the patient's medical record.

INDICATIONS

LENVIMA^® (lenvatinib) is indicated:

Differentiated Thyroid Cancer (DTC)

For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC

Renal Cell Carcinoma (RCC)

In combination with everolimus, for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy

Hepatocellular Carcinoma (HCC)

For the first-line treatment of patients with unresectable HCC

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Hypertension. In DTC (differentiated thyroid cancer), hypertension occurred in 73% of patients on LENVIMA (44% grade 3-4). In RCC (renal cell carcinoma), hypertension occurred in 42% of patients on LENVIMA + everolimus (13% grade 3). Systolic blood pressure ≥160 mmHg occurred in 29% of patients, and 21% had diastolic blood pressure ≥100 mmHg. In HCC (hepatocellular carcinoma), hypertension occurred in 45% of LENVIMA-treated patients (24% grade 3). Grade 4 hypertension was not reported in HCC.

Serious complications of poorly controlled hypertension have been reported. Control blood pressure prior to initiation. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly thereafter during treatment. Withhold and resume at reduced dose when hypertension is controlled or permanently discontinue based on severity.

Cardiac Dysfunction. Serious and fatal cardiac dysfunction can occur with LENVIMA. Across clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction occurred in 3% of LENVIMA-treated patients. Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Arterial Thromboembolic Events. Among patients receiving LENVIMA or LENVIMA + everolimus, arterial thromboembolic events of any severity occurred in 2% of patients in RCC and HCC and 5% in DTC. Grade 3-5 arterial thromboembolic events ranged from 2% to 3% across all clinical trials.

Among patients receiving LENVIMA with pembrolizumab, arterial thrombotic events of any severity occurred in 5% of patients in CLEAR, including myocardial infarction (3.4%) and cerebrovascular accident (2.3%).

Permanently discontinue following an arterial thrombotic event. The safety of resuming after an arterial thromboembolic event has not been established, and LENVIMA has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.

Hepatotoxicity. Across clinical studies enrolling 1327 LENVIMA-treated patients with malignancies other than HCC, serious hepatic adverse reactions occurred in 1.4% of patients. Fatal events, including hepatic failure, acute hepatitis and hepatorenal syndrome, occurred in 0.5% of patients. In HCC, hepatic encephalopathy occurred in 8% of LENVIMA-treated patients (5% grade 3-5). Grade 3-5 hepatic failure occurred in 3% of LENVIMA-treated patients; 2% of patients discontinued LENVIMA due to hepatic encephalopathy, and 1% discontinued due to hepatic failure.

Monitor liver function prior to initiation, then every 2 weeks for the first 2 months, and at least monthly thereafter during treatment. Monitor patients with HCC closely for signs of hepatic failure, including hepatic encephalopathy. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Renal Failure or Impairment. Serious including fatal renal failure or impairment can occur with LENVIMA. Renal impairment was reported in 14% and 7% of LENVIMA-treated patients in DTC and HCC, respectively. Grade 3-5 renal failure or impairment occurred in 3% of patients with DTC and 2% of patients with HCC, including 1 fatal event in each study. In RCC, renal impairment or renal failure was reported in 18% of LENVIMA + everolimus–treated patients (10% grade 3).

Initiate prompt management of diarrhea or dehydration/
hypovolemia. Withhold and resume at reduced dose upon recovery or permanently discontinue for renal failure or impairment based on severity.

Proteinuria. In DTC and HCC, proteinuria was reported in 34% and 26% of LENVIMA-treated patients, respectively. Grade 3 proteinuria occurred in 11% and 6% in DTC and HCC, respectively. In RCC, proteinuria occurred in 31% of patients receiving LENVIMA + everolimus (8% grade 3). Monitor for proteinuria prior to initiation and periodically during treatment. If urine dipstick proteinuria ≥2+ is detected, obtain a 24-hour urine protein. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Diarrhea. Of the 737 LENVIMA-treated patients in DTC and HCC, diarrhea occurred in 49% (6% grade 3). In RCC, diarrhea occurred in 81% of LENVIMA + everolimus–treated patients (19% grade 3). Diarrhea was the most frequent cause of dose interruption/reduction, and diarrhea recurred despite dose reduction. Promptly initiate management of diarrhea. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Fistula Formation and Gastrointestinal Perforation. Of the 799 patients treated with LENVIMA or LENVIMA + everolimus in DTC, RCC, and HCC, fistula or gastrointestinal perforation occurred in 2%. Permanently discontinue in patients who develop gastrointestinal perforation of any severity or grade 3- 4 fistula.

QT Interval Prolongation. In DTC, QT/QTc interval prolongation occurred in 9% of LENVIMA-treated patients and QT interval prolongation of >500 ms occurred in 2%. In RCC, QTc interval
increases of >60 ms occurred in 11% of patients receiving LENVIMA + everolimus and QTc interval >500 ms occurred in 6%. In HCC, QTc interval increases of >60 ms occurred in 8% of LENVIMA-treated patients and QTc interval >500 ms occurred in 2%.

Monitor and correct electrolyte abnormalities at baseline and periodically during treatment. Monitor electrocardiograms in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or those who are taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics. Withhold and resume at reduced dose upon recovery based on severity.

Hypocalcemia. In DTC, grade 3-4 hypocalcemia occurred in 9% of LENVIMA-treated patients. In 65% of cases, hypocalcemia improved or resolved following calcium supplementation with or without dose interruption or dose reduction. In RCC, grade 3-4 hypocalcemia occurred in 6% of LENVIMA + everolimus–treated patients. In HCC, grade 3 hypocalcemia occurred in 0.8% of LENVIMA-treated patients. Monitor blood calcium levels at least monthly and replace calcium as necessary during treatment. Withhold and resume at reduced dose upon recovery or permanently discontinue depending on severity.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Across clinical studies of 1823 patients who received LENVIMA as a single agent, RPLS occurred in 0.3%. Confirm diagnosis of RPLS with MRI. Withhold and resume at reduced dose upon recovery or permanently discontinue depending on severity and persistence of neurologic symptoms.

Hemorrhagic Events. Serious including fatal hemorrhagic events can occur with LENVIMA. In DTC, RCC, and HCC clinical trials, hemorrhagic events, of any grade, occurred in 29% of the 799 patients treated with LENVIMA as a single agent or in combination with everolimus. The most frequently reported hemorrhagic events (all grades and occurring in at least 5% of patients) were epistaxis and hematuria. In DTC, grade 3-5 hemorrhage occurred in 2% of LENVIMA-treated patients, including 1 fatal intracranial hemorrhage among 16 patients who received LENVIMA and had CNS metastases at baseline. In RCC, grade 3-5 hemorrhage occurred in 8% of LENVIMA + everolimus–treated patients, including 1 fatal cerebral hemorrhage. In HCC, grade 3-5 hemorrhage occurred in 5% of LENVIMA-treated patients, including 7 fatal hemorrhagic events. Serious tumor-related bleeds, including fatal hemorrhagic events, occurred in LENVIMA-treated patients in clinical trials and in the postmarketing setting. In postmarketing surveillance, serious and fatal carotid artery hemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than other tumors. Safety and effectiveness of LENVIMA in patients with ATC have not been demonstrated in clinical trials.

Consider the risk of severe or fatal hemorrhage associated with tumor invasion or infiltration of major blood vessels (eg, carotid artery). Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction. LENVIMA impairs exogenous thyroid suppression. In DTC, 88% of patients had baseline thyroid stimulating hormone (TSH) level ≤0.5 mU/L. In patients with normal TSH at baseline, elevation of TSH level >0.5 mU/L was observed post baseline in 57% of LENVIMA-treated patients. In RCC and HCC, grade 1 or 2 hypothyroidism occurred in 24% of LENVIMA + everolimus–treated patients and 21% of LENVIMA- treated patients, respectively. In patients with normal or low TSH at baseline, elevation of TSH was observed post baseline in 70% of LENVIMA-treated patients in HCC and 60% of LENVIMA + everolimus– treated patients in RCC.

Monitor thyroid function prior to initiation and at least monthly during treatment. Treat hypothyroidism according to standard medical practice.

Impaired Wound Healing. Impaired wound healing has been reported in patients who received LENVIMA. Withhold LENVIMA for at least 1 week prior to elective surgery. Do not administer for at least 2 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 (ONJ). ONJ has been reported in patients receiving LENVIMA. Concomitant exposure to other risk factors, such as bisphosphonates, denosumab, dental disease, or invasive dental procedures, may increase the risk of ONJ.

Perform an oral examination prior to treatment with LENVIMA and periodically during LENVIMA treatment. Advise patients regarding good oral hygiene practices and to consider having preventive dentistry performed prior to treatment with LENVIMA and throughout treatment with LENVIMA.

Avoid invasive dental procedures, if possible, while on LENVIMA treatment, particularly in patients at higher risk. Withhold LENVIMA for at least 1 week prior to scheduled dental surgery or invasive dental procedures, if possible. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk of ONJ.

Withhold LENVIMA if ONJ develops and restart based on clinical judgement of adequate resolution.

Embryo‐Fetal Toxicity. Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to pregnant women. In animal reproduction studies, oral administration of lenvatinib during organogenesis at doses below the recommended clinical doses resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats and rabbits. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception during treatment with LENVIMA and for 30 days after the last dose.

Adverse Reactions

In DTC, the most common adverse reactions (≥30%) observed in LENVIMA-treated patients were hypertension (73%), fatigue (67%), diarrhea (67%), arthralgia/myalgia (62%), decreased appetite (54%), decreased weight (51%), nausea (47%), stomatitis (41%), headache (38%), vomiting (36%), proteinuria (34%), palmar-plantar erythrodysesthesia syndrome (32%), abdominal pain (31%), and dysphonia (31%). The most common serious adverse reactions (≥2%) were pneumonia (4%), hypertension (3%), and dehydration (3%). Adverse reactions led to dose reductions in 68% of LENVIMA-treated patients; 18% discontinued LENVIMA. The most common adverse reactions (≥10%) resulting in dose reductions were hypertension (13%), proteinuria (11%), decreased appetite (10%), and diarrhea (10%); the most common adverse reactions (≥1%) resulting in discontinuation of LENVIMA were hypertension (1%) and asthenia (1%).

In RCC, the most common adverse reactions (≥30%) observed in LENVIMA + everolimus-treated patients were diarrhea (81%), fatigue (73%), arthralgia/myalgia (55%), decreased appetite (53%), vomiting (48%), nausea (45%), stomatitis (44%), hypertension (42%), peripheral edema (42%), cough (37%), abdominal pain (37%), dyspnea (35%), rash (35%), decreased weight (34%), hemorrhagic events (32%), and proteinuria (31%). The most common serious adverse reactions (≥5%) were renal failure (11%), dehydration (10%), anemia (6%), thrombocytopenia (5%), diarrhea (5%), vomiting (5%), and dyspnea (5%). Adverse reactions led to dose reductions or interruption in 89% of patients. The most common adverse reactions (≥5%) resulting in dose reductions were diarrhea (21%), fatigue (8%), thrombocytopenia (6%), vomiting (6%), nausea (5%), and proteinuria (5%). Treatment discontinuation due to an adverse reaction occurred in 29% of patients.

In HCC, the most common adverse reactions (≥20%) observed in LENVIMA-treated patients were hypertension (45%), fatigue (44%), diarrhea (39%), decreased appetite (34%), arthralgia/myalgia (31%), decreased weight (31%), abdominal pain (30%), palmar-plantar erythrodysesthesia syndrome (27%), proteinuria (26%), dysphonia (24%), hemorrhagic events (23%), hypothyroidism (21%), and nausea (20%). The most common serious adverse reactions (≥2%) were hepatic encephalopathy (5%), hepatic failure (3%), ascites (3%), and decreased appetite (2%). Adverse reactions led to dose reductions or interruption in 62% of patients. The most common adverse reactions (≥5%) resulting in dose reductions were fatigue (9%), decreased appetite (8%), diarrhea (8%), proteinuria (7%), hypertension (6%), and palmar-plantar erythrodysesthesia syndrome (5%). Treatment discontinuation due to an adverse reaction occurred in 20% of patients. The most common adverse reactions (≥1%) resulting in discontinuation of LENVIMA were fatigue (1%), hepatic encephalopathy (2%), hyperbilirubinemia (1%), and hepatic failure (1%).

Use in Specific Populations

Because of the potential for serious adverse reactions in breastfed children, advise women to discontinue breastfeeding during treatment and for 1 week after the last dose. LENVIMA may impair fertility in males and females of reproductive potential.

No dose adjustment is recommended for patients with mild (CLcr 60-89 mL/min) or moderate (CLcr 30- 59 mL/min) renal impairment. LENVIMA concentrations may increase in patients with DTC, RCC, or EC (endometrial carcinoma) and severe (CLcr 15-29 mL/min) renal impairment. Reduce the dose for patients with DTC, RCC, or EC and severe renal impairment. There is no recommended dose for patients with HCC and severe renal impairment. LENVIMA has not been studied in patients with end-stage renal disease.

No dose adjustment is recommended for patients with HCC and mild hepatic impairment (Child-Pugh A). There is no recommended dose for patients with HCC with moderate (Child-Pugh B) or severe (Child- Pugh C) hepatic impairment. No dose adjustment is recommended for patients with DTC, RCC, or EC and mild or moderate hepatic impairment. LENVIMA concentrations may increase in patients with DTC, RCC, or EC and severe hepatic impairment. Reduce the dose for patients with DTC, RCC, or EC and severe hepatic impairment.

For more information about LENVIMA, please see full Prescribing Information.

INDICATIONS

LENVIMA^® (lenvatinib) is indicated:

Differentiated Thyroid Cancer (DTC)

For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC

Renal Cell Carcinoma (RCC)

In combination with everolimus, for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy

Hepatocellular Carcinoma (HCC)

For the first-line treatment of patients with unresectable HCC