lenvatinib

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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 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.

To make sure lenvatinib is safe for you, 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.

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 2 weeks after your last dose.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether lenvatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take lenvatinib?

Lenvatinib is usually taken once per day. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take lenvatinib with or without food. Take the medicine at the same time each day.

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.

Do not crush, chew, break, or open the lenvatinib capsules. Swallow them whole.

To make swallowing easier, you may 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.
  • Swallow the mixture right away without chewing. Do not save it for later use.
  • To make sure you get the entire dose, add 1 more tablespoon of liquid to the same glass, swirl gently and drink right away.

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.

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.

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

While using lenvatinib, you will need frequent blood and urine tests. 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?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

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;
  • severe headache, vision problems, weakness, confusion, seizure (convulsions);
  • easy bruising, unusual bleeding (nosebleeds, bleeding gums), 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 --shortness of breath (even with mild exertion), swelling in your ankles, chest pain or pressure, pain spreading to your jaw or shoulder;
  • symptoms of a blood clot --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low calcium levels --numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • kidney problems --little or no urinating, painful or difficult urination, pain in your lower back; or
  • dangerously high blood pressure --pounding in your neck or ears, nosebleed, anxiety, severe chest pain, irregular heartbeats.

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

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea;
  • loss of appetite, weight loss;
  • muscle or joint pain;
  • mouth sores;
  • rash, redness, itching, or peeling on the palms of your hands or the soles of your feet;
  • headache, tiredness; or
  • cough, 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, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with lenvatinib.

This list is not complete. Other drugs may interact with lenvatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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.

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