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 (DTC) when the disease can no longer be treated with radioactive iodine and is progressing. It is also indicated for patients with advanced renal cell cancer (RCC) in combination with Afinitor® who have had one prior anti-angiogenic treatment.

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 once daily at the same time, with or without food. However, dosage differs depending on which disease is being treated. Patients with RCC will also take an Afinitor capsule along with the Lenvima capsule.

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 side effects of treatment with Lenvima?

For DTC patients:

• 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

For RCC patients:

• Fatigue
• Decreased appetite
• Nausea
• Swelling in arms and legs
• Stomach pain
• Rash
• Bleeding
• Joint and muscle pain
• Vomiting
• Mouth sores
• Cough
• Trouble breathing
• Weight loss

What are some of the less common but potentially serious side effects of Cabometyx?

• High blood pressure
• Heart problems
• Problems with blood clots in your arteries
• Liver problems
• Increased protein in your urine
• Severe diarrhea
• An opening in the wall of your of your stomach or intestines (perforation) or an abnormal connection between two parts of your GI tract (fistula)
• Irregular heartbeat
• A condition called Reversible Posterior Leukoencephalopathy Syndrome(RLPS)
• Serious bleeding
• Change is thyroid levels

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?

• 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 about all of your health conditions, especially if you have (or have had):

• 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

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

When should patients notify their physician? You should notify your physician if you have any side effects that bother you or don’t go away, or if you experience any of the following:

• 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 stools (looks like tar)
• 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.

Last updated on: 06/16.

Important Limitations of Use

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