Frequently asked questions
about LENVIMA ^®

LENVIMA is a prescription medicine that is used to treat people with 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 by 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 pembrolizumab as your first treatment when your kidney cancer has spread or cannot be removed by surgery
• 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
• LENVIMA is used along with another medicine called pembrolizumab to treat advanced endometrial carcinoma (EC), a type of uterine cancer:
• when a laboratory test shows that your tumor is mismatch repair proficient (pMMR) or not microsatellite instability high (MSI-H), and
• you have received anti-cancer treatment, and it is no longer working, and
• your cancer cannot be cured by surgery or radiation

The safety and efficacy of LENVIMA have not been established in children.

Learn more about LENVIMA for advanced endometrial cancer* and as a first-line treatment for renal cell carcinoma* here.

*Taken in combination with pembrolizumab.

LENVIMA isn’t chemotherapy. It is an oral medicine known as a targeted therapy. It is called that because it targets certain proteins on cancer cells that cause the cells to grow and multiply.

FDA-approved LENVIMA is an oral therapy that helps block tumor growth in certain types of cancer. LENVIMA is a signal-blocking oral drug called a tyrosine kinase inhibitor (TKI).

How LENVIMA is thought to work:

1. Cancer cells send out signals that tell the body to make more blood vessels.
2. The cancer uses these new blood vessels to grow and spread.
3. LENVIMA helps block these signals by targeting certain proteins on cancer cells that cause the cells to grow and multiply. As a result, LENVIMA helps prevent tumors from growing and spreading.
4. Healthy cells also contain these proteins and may be affected by LENVIMA. This can sometimes cause serious side effects.

LENVIMA is used by itself to treat DTC, a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing.

LENVIMA was studied in a clinical trial of 392 people with DTC that had progressed and who were no longer responding to treatment with RAI.

LENVIMA is FDA approved to treat adults with a type of kidney cancer called advanced RCC along with the medicine everolimus after one course of treatment with another anti-cancer medicine (anti-angiogenic therapy).

The combination treatment of LENVIMA + everolimus was studied in a clinical trial of 153 people with advanced or metastatic RCC who were treated with one previous anticancer medicine compared to everolimus alone.

LENVIMA is FDA-approved to treat adults with advanced RCC along with the medicine pembrolizumab as first treatment when kidney cancer has spread or cannot be removed by surgery. Learn more about this clinical trial.

LENVIMA is FDA approved to be used by itself as the first treatment for a type of liver cancer called HCC when it cannot be removed by surgery

It was studied in a clinical trial of 954 people with previously untreated HCC that could not be removed with surgery. In this trial, people with HCC were randomly assigned to receive either LENVIMA or sorafenib, another targeted therapy.

It’s important to tell your doctor about all of your medical conditions, including if you:

• have high blood pressure
• have heart problems
• have a history of blood clots in your arteries (type of blood vessel), including stroke, heart attack, or change in vision
• have or have had liver or kidney problems
• have a history of a tear (perforation) in your stomach or intestine, or an abnormal connection between two or more body parts (fistula)
• have headaches, seizures, or vision problems
• have any bleeding problems
• plan to have surgery, a dental procedure, or have had a recent surgery. You should stop taking LENVIMA at least 1 week before planned surgery
• are pregnant or plan to become pregnant. LENVIMA can harm your unborn baby

Females who are able to become pregnant:

• Your doctor should do a pregnancy test before you start treatment with LENVIMA
• You should use an effective method of birth control (contraception) during treatment with LENVIMA and for 30 days after the last dose of LENVIMA. Talk with your doctor about birth control methods you can use during this time. Tell your doctor right away if you become pregnant or think you are pregnant during treatment with LENVIMA
• are 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

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you are taking, or have taken, an osteoporosis medicine. Know the medicines you take. Keep a list of your medicines to show to your doctor and pharmacist when you get a new medicine.

Pregnancy and LENVIMA

Based on the way LENVIMA is thought to work and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to pregnant women. In animal reproduction studies, LENVIMA (at doses below the recommended human doses) resulted in harm to the embryo (embryotoxicity), harm to the fetus (fetotoxicity), and permanent structural and functional birth defects (teratogenicity). There are no available human data informing the risk to pregnant women.

In the US general population, the estimated background risk of major birth defects is between 2% and 4%, and is between 15% and 20% for miscarriages.

Before taking LENVIMA, your doctor should do a pregnancy test. While on LENVIMA, you should use an effective method of birth control (contraception). Tell your doctor right away if you become pregnant or think you are pregnant.

Breastfeeding and LENVIMA

It is not known whether LENVIMA is present in human milk. In animal studies, LENVIMA and its metabolites are excreted in rat milk at concentrations higher than those in maternal plasma.

While on LENVIMA, it is recommended to stop breastfeeding and not resume until 1 week after taking your last LENVIMA dose.

Specialty pharmacies

LENVIMA is available through certain specialty pharmacies, which will mail the medication directly to people. If your medicine is supplied through a specialty pharmacy, your doctor will tell you which one. It is important to know the name of your pharmacy and respond promptly to their phone calls and communications.

Physician office/clinic or hospital pharmacies

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

For more information about how you will receive LENVIMA, please contact your doctor.

LENVIMA is an oral medication, taken once a day at the same time, with or without food. Your doctor will tell you how much LENVIMA to take and when to take it. They may also choose to adjust your dose, stop treatment for some time, or completely stop treatment with LENVIMA if you have side effects.

It’s important that you take LENVIMA exactly as your doctor tells you to take it.

LENVIMA capsules come in color-coded blister cards that contain medicine for 5 days. The number of capsules you need to take may vary. Depending on your prescription, you may need to take more than one capsule at the same time each day.

If you miss a dose of LENVIMA, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take the next dose at your regular time.

If you think you have taken more LENVIMA capsules than you should have, call your doctor or go to the nearest hospital emergency room right away.

Keep LENVIMA in a room with a steady temperature between 68 °F and 77 °F (20 °C and 25 °C).

Keep LENVIMA and all medicines out of reach of children.

Every medication has side effects and impacts each person differently. Below is information about certain side effects for LENVIMA. Tell your doctor right away if you have any of them.

LENVIMA may cause serious side effects, including high blood pressure (hypertension), heart problems, problems with blood clots in your blood vessels (arteries), liver problems, kidney problems, increased protein in your urine (proteinuria), diarrhea, an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula), changes in the electrical activity of your heart called QT prolongation, low levels of blood calcium (hypocalcemia), a condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS), bleeding, change in thyroid hormone levels, wound healing problems, and severe jaw bone problems (osteonecrosis).

The most common side effects of LENVIMA in people treated for DTC 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 RCC 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 HCC 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.

The most common side effects of LENVIMA when given in combination with pembrolizumab include decrease in thyroid hormone levels, tiredness, joint and muscle pain, nausea, decreased appetite, vomiting, mouth sores, weight loss, stomach-area (abdomen) pain, urinary tract infection, constipation, headache, bleeding, rash, redness, itching, or peeling of your skin on your hands and feet, hoarseness, and rash.

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 FDA at 1‑800‑FDA‑1088.

Learn more about LENVIMA for advanced endometrial cancer* and as a first-line treatment for renal cell carcinoma* here.

*Taken in combination with pembrolizumab.

It’s important to have an open and ongoing conversation with your health care team.

If you experience side effects while taking LENVIMA, your health care provider will determine the best way to manage them. This may include changing your dose of LENVIMA, taking a break from one or both medications, or stopping treatment completely if you have certain side effects.

Keep in mind, your health care provider will tell you how much LENVIMA to take and when to take it. Do not change the dose of your medicine on your own.

High blood pressure

High blood pressure is a common side effect of LENVIMA and can be serious. It’s important to monitor your blood pressure. Tell your doctor immediately about changes to your blood pressure. If you develop high blood pressure, your doctor may prescribe medicine to help treat it.

These tips may help:

• Get your blood pressure checked regularly. Some people find it helpful to use a blood pressure monitor at home
• If you’re a smoker, consider quitting
• Regular physical activity such as exercise. Talk to your doctor before starting any new activities
• Eat a healthy diet with plenty of whole grains, and try to limit sodium and alcohol

Heart problems

LENVIMA can cause serious heart problems that may lead to death. Call your doctor right away if you get symptoms of heart problems, such as shortness of breath or swelling in your ankles

Diarrhea

Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your doctor 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.

These tips may help:

• Eat easy-to-digest foods and follow any other dietary recommendations provided by your doctor
• Drink plenty of water to prevent dehydration

Fatigue

Feeling tired can be a common side effect.

These tips may help:

• Rest—if you’re able to take short naps during the day
• Move—moderate daily exercise may help, but remember to talk to your doctor before starting or modifying your exercise program
• Hydrate—try to drink more water. Dehydration can make you feel tired
• Reach out—don’t be afraid to ask for help

Learn more about side effects for LENVIMA and pembrolizumab here.

You are encouraged to report negative side effects to Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

There are available options for help you pay for LENVIMA if you are eligible.

LENVIMA Co-Pay Program

With the LENVIMA Co-Pay Program, eligible commercially insured patients may pay as little as $0 per month.* Annual limits apply. Depending on your insurance plan, you could have additional financial responsibility. See www.eisaipatientsupport.com/hcp/lenvima for complete terms and conditions.

*Not available to patients enrolled in state or federal healthcare programs, including Medicare, Medigap, VA, DoD, or TRICARE.

Eisai Patient Support

If you need further information or help paying for LENVIMA, Eisai Patient Support may be able to help. Contact Eisai Patient Support directly at 1-866-613-4724.

Eisai Patient Support is your resource for information about coverage of LENVIMA and available financial assistance options. It will help you:

• Determine your insurance coverage for LENVIMA and where to access your medication
• Manage your out-of-pocket costs for LENVIMA and determine eligibility for assistance if you cannot afford your medication

Eisai Patient Support is your resource for information about coverage of LENVIMA and available financial assistance options. It will help you:

• Understand how your therapy may be covered by your insurance*
• Learn more about out-of-pocket costs for your treatment
• Determine eligibility for assistance if you cannot afford your medication

Contact Eisai Patient Support directly at 1-866-613-4724.

*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 medical record.

There is a list of advocacy groups that offer support for cancer patients and their caregivers.