lenvima

Lenvima (lenvatinib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Lenvima is used to treat thyroid cancer.

Lenvima is usually given after radioactive iodine has been tried without success.

Important information

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).

Before taking this medicine

You should not use Lenvima if you are allergic to lenvatinib, or if you have:

• uncontrolled high blood pressure;

• congestive heart failure;

• a heart rhythm disorder;

• personal or family history of long QT syndrome; or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

To make sure Lenvima is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• high blood pressure;

• bleeding problems;

• headaches or vision problems;

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

• a seizure disorder; or

• a history of heart attack, heart failure, stroke, or blood clot.

Do not use Lenvima 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 treatment ends.

Lenvima 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 Lenvima?

Take Lenvima exactly as it was prescribed for you. 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 Lenvima with or without food.

Take the medicine at the same time each day.

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

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

While using Lenvima, 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.

Lenvima dosing information

Usual Adult Dose of Lenvima for Thyroid Cancer:

24 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity occurs

Use: Treatment of patient with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

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 Lenvima?

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

Lenvima side effects

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 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, rapid weight gain, 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.

Common Lenvima side effects may include:

• stomach pain, nausea, vomiting, diarrhea;

• loss of appetite, weight loss;

• muscle or joint pain;

• mouth sores;

• rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;

• headache, tiredness; or

• 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.

See also: Side effects (in more detail)

What other drugs will affect Lenvima?

Lenvima 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 Lenvima.

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.