Class: Biological Therapy

Generic Name: Lenvatinib

Trade Name: Lenvima®

For which conditions is this drug approved? Lenvima is approved to treat people with a type of thyroid cancer called differentiated thyroid cancer when the disease can no longer be treated with radioactive iodine and is progressing.

What is the mechanism of action? Lenvima is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing.

How is Lenvima typically given (administered)? Lenvima comes in a capsule and is taken orally. Take Lenvima one time each day at the same time, with or without food.

How are patients typically monitored? While you’re taking Lenvima, your doctor will monitor your:

  • Blood pressure
  • Heart function
  • Liver function
  • Your blood vessels for clots
  • The amount of protein in your urine (an abnormal amount is a condition known as proteinuria)

What are the common (occur in 30% or more of patients) side effects of treatment with Lenvima?

  • High blood pressure
  • Diarrhea
  • Nausea
  • Vomiting
  • Stomatitis (inflammation of the mouth and lips)
  • Abdominal pain
  • Fatigue
  • Joint pain
  • Weight loss
  • Loss of appetite
  • Headache
  • Proteinuria
  • Hand-foot syndrome
  • Deepening voice

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Lenvima?

  • Constipation
  • Mouth pain
  • Dry mouth
  • Indigestion and heartburn
  • Peripheral edema
  • Change in sense of taste
  • Dizziness
  • Rash
  • Hair loss
  • Cough
  • Nose bleed
  • Insomnia
  • Dental and oral infections
  • Urinary tract infection

 This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all of your health conditions, especially if you have (or have hade):
  • High blood pressure
  • Heart problems
  • A history of blood clots in your arteries (type of blood vessel), including stroke, heart attack, or change in vision
  • Kidney or liver problems
  • A history of a tear (perforation) in your stomach or intestine, or an 
abnormal connection between two parts of your gastrointestinal tract (fistula)
  • Headaches, seizures, or vision problems
  • Bleeding problems
  • Take Lenvima exactly as your healthcare provider tells you to take it.
  • If you miss a dose of Lenvima, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take the next dose at your regular time.
  • If you take too much Lenvima, call your healthcare provider or go to the nearest hospital emergency room right away.

Are there any special precautions patients should be aware of before starting treatment?

  • Tell your doctor if you are pregnant or plan to become pregnant. Lenvima may harm your unborn baby, so you should not become pregnant during treatment. If you become pregnant during treatment or think you may be pregnant, tell your healthcare provider right away.
  • Women who are able to become pregnant should use effective birth control during treatment with Lenvima and for at least two after the last dose.
  • Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Lenvima will pass into your breast milk. You and your healthcare provider should decide if you will take Lenvima or breastfeed—you should not do both.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of the medicines you take and show them to your healthcare providers and pharmacist when you get a new medicine.

When should patients notify their physician?

  • Call your doctor if you have any side effects that bother you or don’t go away.
  • Call your doctor right away if you experience any of the following sigs of a serious complication:
  • Shortness of breath
  • Swelling of your ankles.
  • Severe chest pain or pressure
  • Pain in your arms, back, neck
or jaw
  • Shortness of breath
  • Numbness or weakness on one side of your body
  • Trouble talking
  • Sudden severe headache
  • Sudden vision changes
  • Severe abdominal pain
  • Severe headache
  • Seizures
  • Weakness
  • Confusion
  • Blindness or change in vision
  • Severe and persistent nose bleeds
  • Vomiting blood
  • Red or black (looks like tar) stools
  • Coughing up blood or blood clots
  • Heavy or new onset vaginal bleeding

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.