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Coronavirus (COVID-19) Update
At Exelixis, we are committed to serving the needs of people who take CABOMETYX. Find more information about our response to the coronavirus pandemic on our corporate website.

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What is liver cancer?

Liver cancer is a disease in which cancer cells develop in the liver. These cells often form a mass of tissue known as a tumor. The most common form of liver cancer begins in the cells of the liver, known as hepatocytes. It is called hepatocellular carcinoma (HCC). Doctors stage liver cancer to figure out how severe the cancer is and how to best treat it.

Liver diagram; Hepatocytes

What are the stages of liver cancer?

There are four stages of liver cancer (listed below). These stages are based on the size of the tumor, whether it has spread, and how far it has spread. Your oncology doctor or nurse can explain how these stages apply to you.

Stage I The tumor is only in the liver and is smaller than 2 cm (1A) OR larger than 2 cm (1B)
Stage II One tumor that is larger than 2 cm and has grown into blood vessels, OR more than one tumor but none larger than 5 cm. None of the tumors have spread to lymph nodes or to other parts of the body
Stage III More than one tumor, with at least one larger than 5 cm, OR one or more tumors that have grown into a large vein of the liver (IIIB). None of the tumors have spread to lymph nodes or to other parts of the body
Stage IV A tumor or tumors that have spread to nearby lymph nodes (IVA) or to other organs, such as the lung or bones (IVB)

Liver cancer spreads when cancer cells break away from the tumor and travel. These cells can invade nearby lymph nodes, tissues, and organs as well as other parts of the body. When liver cancer spreads to lymph nodes or other organs (Stage IV), it is considered advanced liver cancer.

What are your treatment options?

The choice of therapy for liver cancer depends on the stage of your cancer, how well your liver is working, and your overall health. Your healthcare team members will work together to choose the treatment that is right for you.

In addition to your oncology doctor, your team may include some of the following healthcare professionals who treat people with liver cancer: hepatobiliary (liver) surgeons, surgical oncologists, gastroenterologists, radiation oncologists, oncology nurses, and registered dietitians.

The team will consider the treatments that are available, including:

Surgery

Surgery: removing the whole liver and replacing it with a healthy liver (liver transplant), or removing the part with cancer. Surgery is an option only with early stage cancer that has not spread to lymph nodes or other organs

Ablation

Ablation: a procedure designed to destroy the cancer in your liver using heat, lasers, or microwaves

Embolization

Embolization: a procedure that blocks the flow of blood into the blood vessel that feeds the tumor to stop the cancer from growing

Targeted Therapy

Targeted therapy: a category of treatment including drugs that target specific features of cancer cells that help them grow. They may also affect normal cells, causing side effects. Kinase inhibitors are one type of targeted therapy used to treat liver cancer.

Kinase inhibitors block molecules known to send signals that tell cancer cells to grow. Without these signals, the tumor often stops growing or shrinks.

Some kinase inhibitors also have anti-angiogenic effects. These effects stop or slow the growth of new blood vessels that feed a tumor. Without new blood vessels to nourish it, the tumor often stops growing or shrinks.

Radiation Therapy

Radiation therapy: a procedure that uses high-energy rays to destroy cancer cells in the liver

CABOMETYX is a type of therapy called a tyrosine kinase inhibitor, which is in the category of targeted therapies. You may hear your oncology doctor refer to it as a TKI.

INDICATIONS AND IMPORTANT SAFETY INFORMATION


What is CABOMETYX?
CABOMETYX is a prescription medicine used to treat:

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

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION


What is CABOMETYX?
CABOMETYX is a prescription medicine used to treat:

  • People with kidney cancer (renal cell carcinoma). CABOMETYX may be used:
    • Alone to treat people with renal cell carcinoma (RCC) that has spread (advanced RCC)
    • In combination with nivolumab when your cancer has spread (advanced RCC), and you have not already had treatment for your advanced RCC
  • People with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

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

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, including:
Bleeding (hemorrhage). CABOMETYX can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with CABOMETYX, including:

  • Coughing up blood or blood clots
  • Vomiting blood or if your vomit looks like coffee grounds
  • Red or black (looks like tar) stools
  • Menstrual bleeding that is heavier than normal
  • Any unusual or heavy bleeding

A tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you get tenderness or pain in your stomach area (abdomen) that is severe or that does not go away.

Blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you get:

  • Swelling or pain in your arms or legs
  • Shortness of breath
  • Feel lightheaded or faint
  • Sweating more than usual
  • Numbness or weakness of your face, arm or leg, especially on one side of your body
  • Sudden confusion, trouble speaking or understanding
  • Sudden trouble seeing in one or both eyes
  • Sudden trouble walking
  • Dizziness, loss of balance or coordination
  • A sudden severe headache

High blood pressure (hypertension). Hypertension is common with CABOMETYX and sometimes can be severe. Your healthcare provider will check your blood pressure before starting CABOMETYX and regularly during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. Tell your healthcare provider if you develop severe headaches, nose bleeds, tiredness or confusion, vision changes, chest pain, trouble breathing, irregular heartbeat, or blood in your urine.

Diarrhea. Diarrhea is common with CABOMETYX and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements.

A skin problem called hand-foot skin reaction. Hand-foot skin reactions are common and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.

Liver problems. Liver problems may happen during treatment with CABOMETYX. When CABOMETYX is taken in combination with nivolumab, severe changes in liver function tests may happen more often than if you take CABOMETYX alone. Your healthcare provider will do blood tests to check your liver function before and during treatment with CABOMETYX.

Tell your healthcare provider right away if you develop symptoms of liver problems including: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, bleeding or bruising more easily than normal.

Adrenal gland problems. Your healthcare provider will monitor you for this problem. Your healthcare provider may prescribe hormone replacement therapy or corticosteroid medicines if needed. Tell your healthcare provider right away if you develop any of the following signs or symptoms: extreme tiredness, dizziness or fainting, weakness, nausea, or vomiting.

Protein in your urine and possible kidney problems. Symptoms may include swelling in your hands, arms, legs, or feet. Your healthcare provider will check you for this problem during treatment with CABOMETYX.

Severe jaw bone problems (osteonecrosis). Your healthcare provider should examine your mouth before you start and during treatment with CABOMETYX. Tell your dentist that you are taking CABOMETYX. It is important for you to practice good mouth care during treatment with CABOMETYX. Tell your healthcare provider right away if you develop any symptoms of jaw problems, including: jaw pain, toothache, or sores on your gums.

Wound healing problems. Wound healing problems have happened in some people who take CABOMETYX. Tell your healthcare provider if you plan to have any surgery before or during treatment with CABOMETYX.

  • You should stop taking CABOMETYX at least 3 weeks before planned surgery.
  • Your healthcare provider should tell you when you may start taking CABOMETYX again after surgery.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with CABOMETYX. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with CABOMETYX if you have certain side effects.

The most common side effects of CABOMETYX include:

  • Tiredness
  • Decreased appetite
  • Nausea
  • Vomiting
  • Weight loss
  • Constipation
  • Difficulty speaking

The most common side effects of CABOMETYX when used in combination with nivolumab include:

  • Tiredness
  • Mouth sores
  • Rash
  • Low thyroid hormone levels (hypothyroidism)
  • Pain in muscles, bones, and joints
  • Decreased appetite
  • Nausea
  • Changes in the way things taste
  • Stomach-area (abdominal) pain
  • Cough
  • Upper respiratory tract infection

CABOMETYX may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of CABOMETYX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

If your healthcare provider prescribes CABOMETYX in combination with nivolumab, also read the Medication Guide that comes with nivolumab.

Before you take CABOMETYX, tell your healthcare provider about all of your medical conditions, including if you:

  • Have had a liver problem other than liver cancer.
  • Have a recent history of bleeding, including coughing up or vomiting blood, or black tarry stools.
  • Have an open or healing wound.
  • Have high blood pressure.
  • Plan to have any surgery, dental procedure, or have had a recent surgery. You should stop treatment with CABOMETYX at least 3 weeks before planned surgery.
  • Are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby.
    • If you are able to become pregnant, your healthcare provider will check your pregnancy status before you start treatment with CABOMETYX.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after your final dose of CABOMETYX.
    • Talk to your healthcare provider about birth control methods that may be right for you.
    • If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • Are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your final dose of CABOMETYX.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. CABOMETYX and certain other medicines may affect each other causing side effects.

What should I avoid while taking CABOMETYX?
Avoid drinking grapefruit juice, eating grapefruit or taking supplements that contain grapefruit or St. John’s wort during treatment with CABOMETYX.

Please see the Patient Information in the accompanying full Prescribing Information.