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lenvatinib

Pronunciation: len VA ti nib

Brand: Lenvima

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

Some people taking lenvatinib 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).

What is lenvatinib?

Lenvatinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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

Lenvatinib is also used together with everolimus (Afinitor) to treat advanced kidney cancer when other medicines have not been effective.

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

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

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

You should not use lenvatinib if you are allergic to it.

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 seizure disorder;
  • kidney disease; or
  • liver disease.

You may need to have a negative pregnancy test before starting this treatment. Do not use lenvatinib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because lenvatinib can harm an unborn baby.

It is not safe to breast-feed a baby while you are using this medicine. Also do not breast-feed for at least 1 week after your last dose.

How should I take lenvatinib?

Lenvatinib is usually taken once per day. 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 lenvatinib capsules with different amounts (strengths) of medicine 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 the capsules (whole, not crushed or broken) into the liquid. Use only enough capsules for one dose.
  • Allow the capsules to dissolve in the liquid 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.

Lenvatinib is usually given until your body no longer responds to the medication.

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

You may need to take medicine to prevent diarrhea while you are using lenvatinib. Carefully follow your doctor's instructions about when to start taking the anti-diarrhea medicine.

You will need frequent blood and urine tests, and your blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

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?

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

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?

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

Some people taking lenvatinib 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, change in mental status, vision loss, seizure (convulsions);
  • little or no urination;
  • unusual bleeding (nosebleeds, heavy menstrual bleeding), or any other bleeding that will not stop;
  • 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, rapid weight gain, feeling short of breath;
  • signs of a blood clot --sudden numbness or weakness, 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); or
  • increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

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;
  • loss of appetite, weight loss;
  • abnormal thyroid function tests;
  • 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?

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.

Other drugs may affect lenvatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about lenvatinib.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2018 Cerner Multum, Inc. Version: 4.01. Revision date: 8/21/2018.

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