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Generic Name: lenvatinib (len-VA-ti-nib)
Brand Name: Lenvima

Lenvima is used for:

Treating certain types of thyroid cancer. It may also be used for other conditions as determined by your doctor.

Lenvima is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Lenvima if:

  • you are allergic to any ingredient in Lenvima

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lenvima:

Some medical conditions may interact with Lenvima. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have bleeding problems, electrolyte problems, headaches, heart problems (eg, heart failure, slow or irregular heartbeat), high blood pressure, seizures, other thyroid problems, or vision problems
  • if you have a history of certain types of blood clots (eg, heart attack, stroke, vision changes), kidney or liver problems, a tear in your stomach or bowels (perforation) or certain other stomach or bowel problems (fistula)
  • if you are dehydrated or have low blood volume
  • if you are taking any medicines that can cause a certain type of irregular heartbeat (prolonged QT interval). There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure

Some MEDICINES MAY INTERACT with Lenvima. However, no specific interactions with Lenvima are known at this time.

Ask your health care provider if Lenvima may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lenvima:

Use Lenvima as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Lenvima. Talk to your pharmacist if you have questions about this information.
  • Take Lenvima by mouth with or without food.
  • Take Lenvima at the same time of day.
  • Take as you have been told, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • If you miss a dose of Lenvima, take it as soon as possible. If it is less than 12 hours until the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lenvima.

Important safety information:

  • Tell your doctor or dentist that you take Lenvima before you receive any medical or dental care, emergency care, or surgery.
  • High blood pressure may rarely happen.
  • Check your blood pressure as you have been told by your doctor.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • A serious and sometimes fatal brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Lenvima. Call your doctor right away if you have confusion, seizures, severe headache, unusual weakness, or vision loss or other vision changes.
  • Serious and sometimes fatal liver problems have happened with Lenvima. Call your doctor right away if you have symptoms of liver problems (eg, dark urine; pale stools; persistent loss of appetite; unusual nausea, stomach pain, or vomiting; unusual tiredness; yellowing of the skin or eyes).
  • Serious and sometimes fatal bleeding problems have happened with Lenvima. Call your doctor right away if you have symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or bruises that get bigger; or any bleeding that is severe or that you cannot stop).
  • Serious and sometimes fatal stomach or bowel problems (eg, holes in the stomach or bowels, fistulas) have rarely happened with Lenvima. Discuss any questions or concerns with your doctor.
  • Serious blood clots like heart attack and stroke have happened with Lenvima. Call your doctor right away if you have symptoms of heart attack (eg, chest pain or pressure; arm, back, neck, or jaw pain; shortness of breath). Call your doctor right away if you have symptoms of stroke (eg, confusion, one-sided weakness, severe dizziness or headache, vision or speech changes).
  • Lenvima may cause fertility problems. This may affect being able to have children. Talk with your doctor.
  • Lenvima may affect sperm in men. This may affect being able to father a child. Talk with your doctor.
  • If you may become pregnant, you must use an effective form of birth control while you take Lenvima and for at least 2 weeks after you stop taking it. If you have questions about effective birth control, talk with your doctor.
  • Have your urine checked as you have been told by your doctor.
  • Lab tests may be performed while you use Lenvima. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Lenvima may cause harm to the fetus. Do not become pregnant while you are using it or within at least 2 weeks after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lenvima while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Lenvima.

Possible side effects of Lenvima:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; constipation; cough; decreased appetite; diarrhea; dizziness; dry mouth; hair loss; headache; indigestion; mouth pain; mouth sores or irritation; muscle or joint pain; nausea; stomach pain; tiredness; trouble sleeping; voice changes; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast or irregular heartbeat; painful urination; redness or irritation of the palms of the hands or soles of the feet; severe or persistent dizziness or headache; severe stomach pain; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; symptoms of fluid and electrolyte problems (eg, confusion, dry mouth or eyes, fainting, fast or irregular heartbeat, mood changes, more thirst, muscle pain or weakness, not hungry, not able to pass urine or change in how much urine is passed, seizures, severe dizziness, severe nausea or vomiting, unusual tiredness or weakness); symptoms of kidney problems (eg, not able to pass urine, change in how much urine is passed, blood in the urine, a big weight gain); symptoms of low blood calcium levels (eg, muscle cramps or spasms, numbness or tingling, seizures).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Lenvima:

Store Lenvima at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lenvima out of the reach of children and away from pets.

General information:

  • If you have any questions about Lenvima, please talk with your doctor, pharmacist, or other health care provider.
  • Lenvima is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Lenvima or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Lenvima. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lenvima. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Lenvima.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.