Lenvima is a kinase inhibitor used to treat certain types of cancer. Kinase inhibitors are enzyme inhibitors that blocks the action of one or more protein kinases which interferes with the growth and spread of cancer cells in the body.

Lenvima is used to treat thyroid cancer. It is usually given after radioactive iodine has been tried without success.

Lenvima is used together with everolimus (Afinitor) to treat advanced kidney cancer in people who have received one treatment course with another cancer medicine.

Lenvima is used together with pembrolizumab (Keytruda) to treat advanced kidney cancer that has spread to other parts of the body (metastatic), or cannot be removed with surgery.

Lenvima is also used together with Keytruda to treat a certain type of endometrial cancer (a type of uterine cancer) that has progressed and cannot be removed with surgery or radiation.

Lenvima is also used to treat liver cancer that cannot be removed with surgery.

Some people taking Lenvima have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Get emergency medical help if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Call your doctor at once if you have signs of serious side effects, including: severe chest pain, shortness of breath, swelling in your ankles, numbness or weakness, confusion, severe headache, problems with speech or vision, seizure (convulsions), unusual bleeding, coughing up blood, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Take Lenvima exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Lenvima at the same time each day, with or without food.

Your doctor will perform tests to make sure Lenvima is the right treatment for you.

To get a full dose, you may need to take a combination of capsules with different amounts (strengths) of lenvatinib in them. Follow your doctor's dosing instructions very carefully.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, dissolve the capsules in water as follows:

• Measure 1 tablespoon of water or apple juice and pour the liquid into a small glass.

• Place only enough capsules for one dose into the liquid. Allow the capsules to dissolve for at least 10 minutes, then stir the mixture for at least 3 more minutes.

• Drink this mixture right away. Add a little more water or juice to the glass, swirl gently and drink right away.

Lenvima can also be given through a feeding tube. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if you are sick with vomiting or severe diarrhea. Prolonged illness can lead to dehydration and kidney failure.

Drink plenty of liquids if you have diarrhea.

Carefully follow your doctor's instructions about when to start taking medicine to prevent diarrhea while you are using Lenvima.

You will need frequent medical tests and blood pressure checks.

Pay special attention to your dental hygiene while taking Lenvima. Brush and floss your teeth regularly.

If you plan to have surgery or a dental procedure, tell the surgeon or dentist you currently use Lenvima. You may need to stop taking the medicine at least 1 week before planned surgery or a dental procedure.

Store at room temperature away from moisture and heat.

Store mixed medicine in the refrigerator and use it within 24 hours. Throw away any medicine not used within that time.

Usual Adult Dose of Lenvima for Thyroid Cancer:

24 mg orally once a day

Comment:
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC)

Usual Adult Dose of Lenvima for Renal Cell Carcinoma:

First-Line Treatment of Patients with Advanced Renal Cell Carcinoma:
20 mg orally once a day given in combination with 200 mg IV pembrolizumab over 30 minutes every 3 weeks

Previously Treated Renal Cell Carcinoma:
18 mg orally once a day given in combination with 5 mg everolimus orally once a day

Comments:
-Refer to everolimus prescribing information for recommended dosing information.
-Refer to pembrolizumab prescribing information for recommended dosing information
-Treatment with everolimus should be continued until disease progression or unacceptable toxicity.
-Treatment with pembrolizumab should be continued until disease progression or unacceptable toxicity or up to 2 years.
-After 2 years of combination with pembrolizumab, this drug may be administered as a single agent until disease progression or unacceptable toxicity.

Uses:
-In combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy
-In combination with pembrolizumab for the first-line treatment of adult patients with advanced renal cell carcinoma

Usual Adult Dose of Lenvima for Hepatocellular Carcinoma:

-Weight less than 60 kg: 8 mg orally once a day
-Weight 60 kg or greater: 12 mg orally once a day

Comment:
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)

Usual Adult Dose of Lenvima for Endometrial Carcinoma:

20 mg orally once daily in combination with pembrolizumab 200 mg IV over 30 minutes every 3 weeks

Comments:
-Refer to the pembrolizumab prescribing information for other dosing information.
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: In combination with pembrolizumab for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation

To make sure you can safely take Lenvima, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a heart attack, heart failure, stroke, or blood clot;

• headaches or vision problems;

• bleeding problems;

• a perforation (a hole or tear) in your stomach or intestines;

• a fistula (an abnormal passageway between parts of your body);

• a seizure disorder;

• a recent surgery or if you plan to have surgery or a dental procedure;

• kidney disease; or

• liver disease.

Lenvima may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

Lenvatinib may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.

Pregnancy may be less likely to occur while the mother or the father is using Lenvima. Women should still use birth control to prevent pregnancy because lenvatinib can harm an unborn baby.

Lenvatinib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Do not breastfeed while using Lenvima, and for at least 1 week after your last dose.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Lenvima: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking Lenvima have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Also call your doctor at once if you have:

• severe diarrhea;

• headache, confusion, weakness, vision loss, seizure (convulsions);

• pain or burning when you urinate, urinating less;

• increased protein in your urine (proteinuria);

• irregular heartbeats;

• unusual bleeding (nosebleeds, heavy menstrual bleeding), or any other bleeding that will not stop;

• severe headache, blurred vision, pounding in your neck or ears;

• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• heart problems - chest pain, pain in your jaw or shoulder, swelling in your lower legs, feeling short of breath;

• signs of a blood clot - sudden numbness or weakness, pain in your arms or back, problems with vision or speech;

• liver problems - dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low calcium level - muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Lenvima side effects may include:

• bleeding;

• stomach pain, nausea, vomiting, diarrhea, constipation;

• loss of appetite, weight loss;

• abnormal urine tests or thyroid function tests, increased blood pressure;

• muscle or joint pain;

• pain and burning when you urinate;

• swelling in your arms and legs;

• mouth sores;

• rash;

• redness, itching, or peeling skin on your hands or feet;

• headache, tiredness; or

• cough, trouble breathing, hoarse voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lenvatinib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially an osteoporosis medicine.

Other drugs may interact with lenvatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.