MANAGING MY
TREATMENT SIDE EFFECTS

Side effects are possible when you take LENVIMA, and some can be serious. It’s important that you talk with your doctor about any side effects. There are steps that can be taken to help manage the side effects of LENVIMA. Your doctor can help you decide what will work best for you. It is important to tell your doctor about any changes in your body, whether you think they are related to your treatment or not.

SERIOUS SIDE EFFECTS

The way that LENVIMA is believed to work not only affects cancer cells but can also affect normal cells. This can lead to serious side effects. Call or see your doctor right away if you develop any symptoms or these symptoms get worse:

High blood pressure (hypertension)
A common side effect of LENVIMA that can be serious.

  • Your blood pressure should be well controlled before starting LENVIMA
  • Your doctor should check your blood pressure regularly during your treatment with LENVIMA. If you develop blood pressure problems, your doctor may prescribe medicine to treat your high blood pressure

Heart problems
LENVIMA can cause serious heart problems that may lead to death. Call your doctor right way if you get symptoms of heart problems such as:

  • Shortness of breath
  • Swelling of your ankles

Problem with blood clots in your blood vessels (arteries)
Get emergency medical help right away if you get any of the following:

  • 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

Liver problems
LENVIMA may cause liver problems that may lead to liver failure and death.

  • Your doctor will check your liver function before and during treatment with LENVIMA
  • Tell your doctor right away if you have any of the following symptoms:
    • Your skin or the white part of your eyes turns yellow (jaundice)
    • Dark “tea-colored” urine
    • Light-colored bowel movements (stools)
    • Feeling drowsy, confused, or loss of consciousness

Kidney problems
Kidney failure, which can lead to death, has happened with LENVIMA treatment.

  • Your doctor should do regular blood tests to check your kidneys

Increased protein in your urine (proteinuria)
It is a common side effect of LENVIMA and can be serious. Proteinuria is when protein is increased in your urine.

  • Your doctor should check your urine for protein before and during your treatment with LENVIMA

Diarrhea
Diarrhea is a common side effect of LENVIMA and can be serious.

  • If you get diarrhea, ask your doctor about what medicines you can take to treat your diarrhea
  • It is important to drink more water when you get diarrhea
  • Tell your doctor or go to the emergency room if you are unable to drink enough liquids and your diarrhea is not able to be controlled

An opening in the wall of your stomach or intestines (perforation), or an abnormal connection between 2 or more body parts (fistula)

  • Get emergency medical help right away if you have severe stomach (abdomen) pain

Changes in the electrical activity of your heart (QT prolongation)
QT prolongation can cause irregular heartbeats that can be life-threatening.

  • Your doctor will do blood tests before and during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an ECG

Low levels of blood calcium (hypocalcemia)

  • Your doctor will check your blood calcium levels during treatment with LENVIMA
  • If your calcium levels are low, your doctor may tell you to take a calcium supplement

A condition called reversible posterior leukoencephalopathy syndrome (RPLS)
Call your doctor right away if you get:

  • Severe headache
  • Seizures
  • Weakness
  • Confusion
  • Blindness or change in vision

Bleeding
LENVIMA may cause serious bleeding problems that may lead to death.

Tell your doctor if you have any signs or symptoms of bleeding during treatment with LENVIMA, including:

  • Severe and persistent nose bleeds
  • Vomiting blood
  • Red or black (looks like tar) stools
  • Blood in your urine
  • Coughing up blood or blood clots
  • Heavy or new-onset vaginal bleeding

Change in thyroid hormone levels

  • Your doctor should check your thyroid hormone levels before starting and every month during treatment with LENVIMA

Wound healing problems
Wound healing problems have happened in some people who take LENVIMA.

  • Tell your doctor if you plan to have any surgery before or during treatment with LENVIMA
  • You should stop taking LENVIMA at least 1 week before planned surgery
  • Your doctor should tell you when you may start taking LENVIMA again after surgery

Severe jaw bone problems (also known as osteonecrosis)
Severe jaw bone problems have happened in some people who have taken LENVIMA.

  • There are certain risk factors that may increase your risk of getting jaw bone problems, such as:
    • Taking a bisphosphonate medicine or the medicine denosumab
    • Having dental disease
    • An invasive dental procedure
  • Your doctor should examine your mouth before you start and during treatment with LENVIMA. It’s important to tell your dentist that you’re taking LENVIMA and to practice good mouth care while taking LENVIMA
  • Tell your doctor right away:
    • If you have any signs or symptoms of jaw bone problems during treatment with LENVIMA, including jaw pain, toothache, or sores on your gums
    • If you plan to have any dental procedures before or during your LENVIMA treatment. You should stop taking LENVIMA at least 1 week before planned dental surgery or invasive dental procedures. Your doctor should tell you when to resume taking LENVIMA. You should avoid having invasive dental procedures, if possible, during treatment with LENVIMA. Stopping your bisphosphonate medicine before an invasive dental procedure may help decrease your risk of getting these jaw problems

The side effects listed here are not all of the possible side effects you might experience with LENVIMA. It’s important to call your doctor for medical advice about side effects or if you have any questions or concerns while taking LENVIMA.

You may also report side effects directly to the Food and Drug Administration (FDA) at 1-800-FDA-1088.

COMMON SIDE EFFECTS

The most common side effects of LENVIMA in people treated for liver cancer include tiredness, decreased appetite, joint and muscle pain, weight loss, stomach (abdomen) pain, rash, redness, itching, or peeling of the skin on your hands and feet, hoarseness, bleeding, change in thyroid hormone levels, and nausea.

MANAGING COMMON SYMPTOMS

There are steps you and your doctor can take to help manage many of the most common symptoms when taking LENVIMA. It’s important to contact your doctor right away if you experience any side effects or if any side effects get worse while you’re taking LENVIMA.

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High blood pressure (HBP)
An increase in blood pressure is a common side effect of treatment with LENVIMA. If you are at higher risk for HBP, are taking medicine for HBP, or have taken it in the past, it is very important to tell your doctor before starting LENVIMA. Your oncologist may work with your primary care provider or your cardiologist to develop a plan to manage your HBP.

Also, it is important to talk to your doctor about how to measure your blood pressure (BP) at home daily, or as often as your doctor recommends. Ask your insurance provider if you are eligible for a blood pressure cuff at no charge. Call your doctor if there are any changes in your BP.
Tiredness Icon
Tiredness (fatigue) If you feel so tired that even resting doesn’t seem to help, that’s fatigue, and it’s a common side effect of LENVIMA. You may need to adjust your schedule to manage this feeling. Ask your doctor for tips on dealing with this side effect.
Increased Protein Icon
Increased protein in your urine (proteinuria) Proteinuria is a common side effect of LENVIMA and can be serious. Your doctor should check your urine for protein before and during your treatment with LENVIMA. If you notice foamy, frothy, or bubbly-looking urine when you use the toilet and/or experience swelling in your hands, feet, abdomen, or face, contact your doctor immediately. If you develop high levels of protein in your urine, your doctor may decrease your dose of LENVIMA or stop your treatment.
Loss of Appetite Icon
Loss of appetite During your treatment with LENVIMA, you may feel like eating less than usual, feel full after eating only a small amount, or even not feel hungry at all. However, keeping up with your nutrition is important to help avoid weight loss and your body not getting the nutrients it needs. Talk with your doctor if you lose your appetite, because it is important you continue to eat consistently.
Weight Loss Icon
Weight loss There are a number of reasons why you might lose weight during your treatment with LENVIMA. Work with your doctor and caregivers to stay focused on your nutrition and hydration (drinking water) while taking LENVIMA. Your doctor should monitor your weight during LENVIMA therapy, but if you notice an unusual decrease, contact your doctor. Ask your doctor if it may be helpful to consult a nutritionist who focuses on patients taking cancer treatments.
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What is LENVIMA?

It is not known if LENVIMA is safe and effective in children.

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What is LENVIMA?

  • LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery

It is not known if LENVIMA is safe and effective in children.

Important Safety Information

LENVIMA may cause serious side effects, including:

  • high blood pressure (hypertension): High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure
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