Welcome to Eisai
Patient
Support
for LENVIMA
From understanding insurance coverage to exploring financial assistance options, Eisai Patient Support (EPS) offers programs, information, and resources to help eligible patients start and stay on treatment. Support includes:
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Insurance
coverage
information -
Appeal
information -
Prior
authorization
information -
Financial
assistance
program
information
Actor Portrayal
FOR US RESIDENTS ONLY
How to Enroll in EPS:
To begin, download the LENVIMA Eisai Patient Support Enrollment Form and speak with your healthcare provider about which program offerings may be right for you:
Download the LENVIMA EPSEnrollment Form Descargar el formulario
de inscripción en español
The Eisai Patient Support Enrollment Form requires information and signatures from both you and your healthcare provider.
Sign electronically at
LENVIMAConsent.com. 
For more information or questions regarding enrollment, call Eisai Patient Support:
1-866-613-4724
Monday through Friday, 9 AM to 6 PM ET
Choose Your Insurance Type for More Information:
Medicare /
Government insurance
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Medicare /
Government insurance -
Employer-Sponsored /
Commercial insurance -
Uninsured
Understanding Medicare & Government Insurance Coverage
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Medicare
Medicare
The Medicare Part D drug benefit provides beneficiaries with coverage for outpatient prescription drugs. The Part D benefit is administered by private health plans, either stand-alone prescription drug plans (PDPs) or Medicare Advantage prescription drug (MA-PD) plans. Medicare established a standard benefit design for Part D with an annual deductible and either co-insurance or a co-pay. Part D plan sponsors may construct their own benefits, as long as their plan provides equal or better coverage than the standard.
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Medicaid
Medicaid
Medicaid is a joint federal and state program that helps with medical costs for some people with limited income and resources. Each state sets its own coverage and eligibility rules for Medicaid programs. However, coverage and patient out-of-pocket costs vary from state to state.
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Veterans Affairs (VA)
Veterans Affairs
The Department of Veterans Affairs (VA) health care system is a direct medical care provider operated by the U.S. government specifically for eligible military veterans. The VA generally delivers medical services directly through its own nationwide network of hospitals, outpatient clinics, and specialized care centers.
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TRICARE
TRICARE
TRICARE is a military health insurance program managed by the Department of War for active personnel, retirees, and their families. It delivers coverage through a combined network of military medical facilities and civilian health care providers worldwide.
Explore Tools & Information to Help You Better Understand Your Medicare Options
Learn more about the Medicare Prescription Payment Plan
The Medicare Prescription Payment Plan (M3P) helps eligible patients who opt in to manage out-of-pocket prescription drug costs by spreading payments over the calendar year. Download an overview explaining how M3P works and how to enroll.
Download M3P GuideThird-Party Resources:
These organizations are independent from Eisai. Eisai does not influence or control the content and cannot guarantee the information provided on these sites. This information is provided to raise awareness and to help determine if you're likely to benefit from M3P. These resources are not an exhaustive list.
GetMyMeds
Learn more about the Medicare Prescription Payment Plan, including how to opt-in to the program and a free cost calculator to help estimate monthly prescription payments throughout the plan year.
Visit GetMyMeds.com
State Health Insurance Assistance Program (SHIP)
Get free, local one-on-one insurance counseling.
Find a SHIP in your area
Or call 1-877-839-2675
Centers for Medicare & Medicaid Services (CMS)
Explore your Medicare coverage options.
Visit CMS.gov
Or call 1-800-MEDICARE
( 1-800-633-4227)
EPS Can Help Eligible Patients Access Programs to Help Pay for LENVIMA
LENVIMA Patient Assistance Program
The LENVIMA Patient Assistance Program provides LENVIMA at no cost to patients in need who meet program eligibility criteria.
To apply for this program, you can download and complete this enrollment form or call Eisai Patient Support at 1-866-613-4724, Monday through Friday, 9 AM to 6 PM ET.
Download the LENVIMA Eisai PatientSupport Program Enrollment Form Descargar el formulario
de inscripción en español
Please note that your signature is required to complete enrollment. You can sign the form electronically by visiting LENVIMAConsent.com.
Visit LENVIMAConsent.com.
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.
WHAT IF MY INSURANCE COMPANY SAYS THEY WON'T PAY FOR LENVIMA?
A denial of coverage or claim occurs if your insurance company refuses to pay for LENVIMA. If this happens, you have the right to appeal this decision and request a detailed written explanation as to why you were denied. For assistance, contact Eisai Patient Support at 1-866-613-4724 (Monday through Friday, 9 AM to 6 PM ET).
Navigating Employer-Sponsored & Commercial Insurance
Commercial insurance is provided by non-government health plans such as health maintenance organizations (HMOs) and preferred provider organizations (PPOs). Many people purchase commercial health insurance through their employer’s health plan, or you can purchase an individual policy directly from commercial insurance providers. The exact coverage you receive depends on the specific policy that you purchase.
Coverage for LENVIMA may vary depending on your insurance provider. The best way to determine your coverage is to talk to your insurance carrier, your physician, or call EPS at 1-866-613-4724 to speak to an Eisai Patient Support Case Manager.
Upon program enrollment, Eisai Patient Support can conduct a benefits investigation to help you understand your plan’s specific coverage for LENVIMA.
Commercially Insured Patients May Be Eligible for the LENVIMA Co-pay Program
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 learn more about the program, including how to enroll, please talk to your pharmacist.
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.
EPS Can Help Eligible Patients Access Programs to Help Pay for LENVIMA
LENVIMA Patient Assistance Program
The LENVIMA Patient Assistance Program provides LENVIMA at no cost to patients in need who meet program eligibility criteria.
To apply for this program, you can download and complete this enrollment form or call Eisai Patient Support at 1-866-613-4724, Monday through Friday, 9 AM to 6 PM ET.
Download the LENVIMA Eisai PatientSupport Program Enrollment Form Descargar el formulario
de inscripción en español
Please note that your signature is required to complete enrollment. You can sign the form electronically by visiting LENVIMAConsent.com.
Visit LENVIMAConsent.com.
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.
WHAT IF MY INSURANCE COMPANY SAYS THEY WON'T PAY FOR LENVIMA?
A denial of coverage or claim occurs if your insurance company refuses to pay for LENVIMA. If this happens, you have the right to appeal this decision and request a detailed written explanation as to why you were denied. For assistance, contact Eisai Patient Support at 1-866-613-4724 (Monday through Friday, 9 AM to 6 PM ET).
Exploring Assistance Options When Uninsured
Uninsured means that you do not have health insurance coverage through an employer-sponsored or commercial insurance plan or a government-funded health insurance program, such as Medicare or Medicaid.
Individuals who are uninsured may be eligible to receive assistance through Eisai Patient Support if they meet the program's eligibility requirements.
EPS Can Help Eligible Patients Access Programs to Help Pay for LENVIMA
LENVIMA Patient Assistance Program
The LENVIMA Patient Assistance Program provides LENVIMA at no cost to patients in need who meet program eligibility criteria.
To apply for this program, you can download and complete this enrollment form or call Eisai Patient Support at 1-866-613-4724, Monday through Friday, 9 AM to 6 PM ET.
Download the LENVIMA Eisai PatientSupport Program Enrollment Form Descargar el formulario
de inscripción en español
Please note that your signature is required to complete enrollment. You can sign the form electronically by visiting LENVIMAConsent.com.
Visit LENVIMAConsent.com.
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.
Information & Resources
To help you navigate your treatment with confidence, the following support tools are available to all patients regardless of insurance status or plan type.
LENVIMA Treatment & Coverage
Learn more about LENVIMA, including:
- How LENVIMA works
- Starting LENVIMA
- What you should know about certain side effects
Visit LENVIMA.com Eisai Patient Support Enrollment
How to enroll in Eisai Patient Support for LENVIMA
This comprehensive resource provides clear instructions to help eligible patients successfully navigate and enroll in the Eisai Patient Support Programs.
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.
Independent Patient Foundations
Certain independent third-party Foundations may offer assistance to eligible patients with healthcare expenses such as travel and lodging, or other expenses such as food, housing, or other state and local resources.
Explore foundations that may be able to help:
View Foundations
Eligibility criteria are determined by each independent third-party foundation. Eisai Patient Support does not determine eligibility and cannot guarantee foundations will offer assistance. Eisai has paid for the right to use this link. Eisai does not review the information on the website for accuracy or completeness and makes no claim about the accuracy of the information.
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Where Can I Get LENVIMA?
Where I Get LENVIMA
LENVIMA can be obtained in two ways:
- Directly From Your Care Center: In some cases, you may obtain LENVIMA directly from an eligible doctor's office, clinic, or hospital pharmacy.
- Through a Specialty Pharmacy: The pharmacy will mail your medication directly to your home. Your healthcare provider will tell you which pharmacy is handling your prescription. For a list of Specialty Pharmacies, please see below.
Please note: It is important to know your Specialty Pharmacy's name and respond quickly to their calls to prevent delays in your treatment.
Your healthcare team can help you determine the best option for you and provide specific details.
Please contact your healthcare team with questions.
Specialty Pharmacies
specialty.optum.comTel: 1-855-427-4682 1-855-427-4682
Fax: 1-877-342-4596 1-877-342-4596
Hours of Operation:
Monday-Friday, 7am to 9pm (CST)
Saturday 8am to 7pm (CST)
Sunday: Closed
acariahealth.
envolvehealth.comTel: 1-800-511-5144 1-800-511-5144
Fax: 1-877-541-1503 1-877-541-1503
Hours of Operation:
Monday-Friday, 8am-8pm (ET)
Saturday, 8am-3pm (ET)
birdirx.comTel: 1-877-437-9012 1-877-437-9012
Fax: 1-877-309-0687 1-877-309-0687
Hours of Operation:
Monday-Friday, 8am-10pm (ET)
Saturday, 8am-4:30pm (ET)
cvsspecialty.comTel: 1-800-799-0692 1-800-799-0692
Fax: 1-855-296-0210 1-855-296-0210
Hours of Operation:
Monday-Friday, 8am-6pm (ET)
accredo.comTel: 1-844-693-0156 1-844-693-0156
Fax: 1-877-247-4847 1-877-247-4847
Hours of Operation:
Monday-Friday, 8am-9pm (ET)
biologicsinc.comTel: 1-800-850-4306 1-800-850-4306
Fax: 1-800-823-4506 1-800-823-4506
Hours of Operation:
Monday-Friday, 8am-8pm (ET)
bioplusrx.comTel: 1-888-292-0744 1-888-292-0744
Fax: 1-800-269-5493 1-800-269-5493
Hours of Operation:
Monday-Friday, 8am-8pm (ET)
www.humana.com/
pharmacy/specialty-rxTel: 1-800-486-2668 1-800-486-2668
Fax: 1-877-405-7940 1-877-405-7940
Hours of Operation:
Monday-Friday, 8am-11pm (ET)
Saturday, 8am-6:30pm (ET)
onco360.comTel: 1-877-662-6633 1-877-662-6633
Fax: 1-877-662-6355 1-877-662-6355
Hours of Operation:
Monday-Friday, 8am-8pm (ET)
Saturday-Sunday, 9am-5:30pm (ET)
walgreens.comTel: 1-877-662-6633 18776626355
Fax: 1-877-662-6355 1-877-662-6355
Hours of Operation:
Monday-Friday, 8am-8pm (ET)
Saturday, 8am-5pm (ET)
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.
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
LENVIMA may cause serious side effects, including:
High blood pressure (hypertension): High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure
Heart problems: LENVIMA can cause serious heart problems that may lead to death. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles
Problem with blood clots in your blood vessels (arteries): Get emergency medical help right away if you get any of the following symptoms: severe chest pain or pressure; pain in your arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; sudden severe headache; sudden vision changes
What is LENVIMA?
LENVIMA is a prescription medicine that is used to treat certain kinds of cancer.
- LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing
- LENVIMA is used to treat adults with a type of kidney cancer called advanced renal cell carcinoma (RCC), along with the medicine everolimus after one course of treatment with another anti-cancer medicine (anti-angiogenic therapy)
- LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery
The safety and efficacy of LENVIMA have not been established in children.
Liver problems: LENVIMA may cause liver problems that may lead to liver failure and death. Your healthcare provider will check your liver function before and during treatment with LENVIMA. Tell your healthcare provider right away if you develop any of the following symptoms: your skin or the white part of your eyes turns yellow (jaundice); dark "tea-colored" urine; light-colored bowel movements (stools); feeling drowsy, confused or loss of consciousness
Kidney problems: Kidney failure, which can lead to death, has happened with LENVIMA treatment. Your healthcare provider should do regular blood tests to check your kidneys
Increased protein in your urine (proteinuria): Proteinuria is a common side effect of LENVIMA and can be serious. Your healthcare provider should check your urine for protein before and during your treatment with LENVIMA
Diarrhea: Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your healthcare provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your healthcare provider or go to the emergency room, if you are unable to drink enough liquids and your diarrhea is not able to be controlled
an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula): Get emergency medical help right away if you develop severe stomach (abdomen) pain
Changes in the electrical activity of your heart called QT prolongation: QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider will do blood tests before and during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an electrocardiogram (ECG)
Low levels of blood calcium (hypocalcemia): Your healthcare provider will check your blood calcium levels during treatment with LENVIMA and may tell you to take a calcium supplement if your calcium levels are low
A condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Call your healthcare provider right away if you get severe headache, seizures, weakness, confusion, or blindness or change in vision
Bleeding: LENVIMA may cause serious bleeding problems that may lead to death. Tell your healthcare provider if you develop any signs or symptoms of bleeding during treatment with LENVIMA, including severe and persistent nose bleeds; vomiting blood; red or black (looks like tar) stools; blood in your urine; coughing up blood or blood clots; heavy or new onset vaginal bleeding
Change in thyroid hormone levels: Your healthcare provider should check your thyroid hormone levels before starting and every month during treatment with LENVIMA
Wound healing problems: Wound healing problems have happened in some people who take LENVIMA. Tell your healthcare provider if you plan to have any surgery before or during treatment with LENVIMA.
- You should stop taking LENVIMA at least 1 week before planned surgery
- Your healthcare provider should tell you when you may start taking LENVIMA again after surgery
Severe jaw bone problems (osteonecrosis): Severe jaw bone problems have happened in some people who take LENVIMA. Certain risk factors such as taking a bisphosphonate medicine or the medicine denosumab, having dental disease, or an invasive dental procedure may increase your risk of getting jaw bone problems. Your healthcare provider should examine your mouth before you start and during treatment with LENVIMA. Tell your dentist that you are taking LENVIMA. It is important for you to practice good mouth care during treatment with LENVIMA. Tell your healthcare provider right away if you have any signs or symptoms of jaw bone problems during treatment with LENVIMA, including jaw pain, toothache, or sores on your gums and if you plan to have any dental procedures before or during treatment with LENVIMA.
- You should stop taking LENVIMA at least 1 week before planned dental surgery or invasive dental procedures
- Your healthcare provider should tell you when you may start taking LENVIMA again after dental procedures
The most common side effects of LENVIMA in people treated for thyroid cancer include tiredness, joint and muscle pain, decreased appetite, weight loss, nausea, mouth sores, headache, vomiting, rash, redness, itching, or peeling of your skin on your hands and feet, stomach (abdomen) pain, and hoarseness.
The most common side effects of LENVIMA in people treated for kidney cancer in combination with everolimus include tiredness, joint and muscle pain, decreased appetite, vomiting, nausea, mouth sores, swelling in your arms and legs, cough, stomach (abdomen) pain, trouble breathing, rash, weight loss, and bleeding.
The most common side effects of LENVIMA in people treated for liver cancer include tiredness, decreased appetite, joint and muscle pain, weight loss, stomach (abdomen) pain, rash, redness, itching, or peeling of your skin on your hands and feet, hoarseness, bleeding, decrease in thyroid hormone levels, and nausea.
LENVIMA may cause fertility problems in males and females and can harm your unborn baby.
Tell your healthcare provider if you are:
- pregnant or plan to become pregnant. For females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with LENVIMA. Use an effective method of birth control (contraception) during treatment with LENVIMA and for 30 days after the last dose of LENVIMA
- breastfeeding or plan to breastfeed. It is not known if LENVIMA passes into your breast milk. Do not breastfeed during treatment with LENVIMA and for 1 week after the last dose
Your healthcare provider may need to reduce your dose of LENVIMA, or delay or completely stop treatment if you have certain side effects.
These are not all the possible side effects of LENVIMA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 1-800-FDA-1088 or visit www.fda.gov/medwatch.
For more information about LENVIMA, please see full Prescribing Information.
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
LENVIMA may cause serious side effects, including:
High blood pressure (hypertension): High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure
Heart problems: LENVIMA can cause serious heart problems that may lead to death. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles
Problem with blood clots in your blood vessels (arteries): Get emergency medical help right away if you get any of the following symptoms: severe chest pain or pressure; pain in your arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; sudden severe headache; sudden vision changes
What is LENVIMA?
LENVIMA may cause serious side effects, including:
LENVIMA is a prescription medicine that is used to treat certain kinds of cancer.
- LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing
- LENVIMA is used to treat adults with a type of kidney cancer called advanced renal cell carcinoma (RCC), along with the medicine everolimus after one course of treatment with another anti-cancer medicine (anti-angiogenic therapy)
- LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery
The safety and efficacy of LENVIMA have not been established in children.
Liver problems: LENVIMA may cause liver problems that may lead to liver failure and death. Your healthcare provider will check your liver function before and during treatment with LENVIMA. Tell your healthcare provider right away if you develop any of the following symptoms: your skin or the white part of your eyes turns yellow (jaundice); dark "tea-colored" urine; light-colored bowel movements (stools); feeling drowsy, confused or loss of consciousness
Kidney problems: Kidney failure, which can lead to death, has happened with LENVIMA treatment. Your healthcare provider should do regular blood tests to check your kidneys
increased protein in your urine (proteinuria): Proteinuria is a common side effect of LENVIMA and can be serious. Your healthcare provider should check your urine for protein before and during your treatment with LENVIMA
Diarrhea: Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your healthcare provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your healthcare provider or go to the emergency room, if you are unable to drink enough liquids and your diarrhea is not able to be controlled
an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula): Get emergency medical help right away if you develop severe stomach (abdomen) pain
Changes in the electrical activity of your heart called QT prolongation: QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider will do blood tests before and during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an electrocardiogram (ECG)
Low levels of blood calcium (hypocalcemia): Your healthcare provider will check your blood calcium levels during treatment with LENVIMA and may tell you to take a calcium supplement if your calcium levels are low
A condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Call your healthcare provider right away if you get severe headache, seizures, weakness, confusion, or blindness or change in vision
Bleeding: LENVIMA may cause serious bleeding problems that may lead to death. Tell your healthcare provider if you develop any signs or symptoms of bleeding during treatment with LENVIMA, including severe and persistent nose bleeds; vomiting blood; red or black (looks like tar) stools; blood in your urine; coughing up blood or blood clots; heavy or new onset vaginal bleeding
Change in thyroid hormone levels: Your healthcare provider should check your thyroid hormone levels before starting and every month during treatment with LENVIMA
Wound healing problems: Wound healing problems have happened in some people who take LENVIMA. Tell your healthcare provider if you plan to have any surgery before or during treatment with LENVIMA.
- You should stop taking LENVIMA at least 1 week before planned surgery
- Your healthcare provider should tell you when you may start taking LENVIMA again after surgery
Severe jaw bone problems (osteonecrosis): Severe jaw bone problems have happened in some people who take LENVIMA. Certain risk factors such as taking a bisphosphonate medicine or the medicine denosumab, having dental disease, or an invasive dental procedure may increase your risk of getting jaw bone problems. Your healthcare provider should examine your mouth before you start and during treatment with LENVIMA. Tell your dentist that you are taking LENVIMA. It is important for you to practice good mouth care during treatment with LENVIMA. Tell your healthcare provider right away if you have any signs or symptoms of jaw bone problems during treatment with LENVIMA, including jaw pain, toothache, or sores on your gums and if you plan to have any dental procedures before or during treatment with LENVIMA.
- You should stop taking LENVIMA at least 1 week before planned dental surgery or invasive dental procedures
- Your healthcare provider should tell you when you may start taking LENVIMA again after dental procedures
The most common side effects of LENVIMA in people treated for thyroid cancer include tiredness, joint and muscle pain, decreased appetite, weight loss, nausea, mouth sores, headache, vomiting, rash, redness, itching, or peeling of your skin on your hands and feet, stomach (abdomen) pain, and hoarseness.
The most common side effects of LENVIMA in people treated for kidney cancer in combination with everolimus include tiredness, joint and muscle pain, decreased appetite, vomiting, nausea, mouth sores, swelling in your arms and legs, cough, stomach (abdomen) pain, trouble breathing, rash, weight loss, and bleeding.
The most common side effects of LENVIMA in people treated for liver cancer include tiredness, decreased appetite, joint and muscle pain, weight loss, stomach (abdomen) pain, rash, redness, itching, or peeling of your skin on your hands and feet, hoarseness, bleeding, decrease in thyroid hormone levels, and nausea.
LENVIMA may cause fertility problems in males and females and can harm your unborn baby.
Tell your healthcare provider if you are:
- pregnant or plan to become pregnant. For females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with LENVIMA. Use an effective method of birth control (contraception) during treatment with LENVIMA and for 30 days after the last dose of LENVIMA
- breastfeeding or plan to breastfeed. It is not known if LENVIMA passes into your breast milk. Do not breastfeed during treatment with LENVIMA and for 1 week after the last dose
Your healthcare provider may need to reduce your dose of LENVIMA, or delay or completely stop treatment if you have certain side effects.
These are not all the possible side effects of LENVIMA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 1-800-FDA-1088 or visit www.fda.gov/medwatch.
For more information about LENVIMA, please see full Prescribing Information.