lenvatinib

What is the most important information I should know about lenvatinib?

What is lenvatinib?

Lenvatinib is used to treat thyroid cancer after radioactive iodine has been tried without success.

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

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

Lenvatinib 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.

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

Lenvatinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking lenvatinib?

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;
• kidney disease; or
• liver disease.

This medicine 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.

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

How should I take lenvatinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

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.

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.

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

You will need frequent medical tests and blood pressure checks.

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

If you need to have any dental work or surgery, tell the dentist or doctor ahead of time that you are using lenvatinib.

What happens if I miss a 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.

What happens if I overdose?

What should I avoid while taking lenvatinib?

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

What are the possible side effects of lenvatinib?

• severe diarrhea;
• headache, confusion, weakness, vision loss, seizure (convulsions);
• pain or burning when you urinate, urinating less;
• 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);
• 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 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;
• 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.

What other drugs will affect lenvatinib?

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

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

Where can I get more information?

Your doctor or pharmacist can provide more information about lenvatinib.