CABOMETYX Differentiated Thyroid Cancer black female patient portrayal

Patient portrayal

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Learn about CABOMETYX for papillary and follicular thyroid cancer (2 types of differentiated thyroid cancer)

What is CABOMETYX?

CABOMETYX is a kind of non-chemotherapy prescription medicine called a tyrosine kinase inhibitor (TKI). It is given as a tablet and taken once a day, or as directed.

It is used to treat:

  • Adults and children 12 years and older with papillary or follicular thyroid cancer (2 types of differentiated thyroid cancer, or DTC) that has progressed after a VEGFR-targeted/TKI medicine and can't be treated with radioactive iodine.

How CABOMETYX may help

CABOMETYX is proven to help certain people with papillary or follicular thyroid cancer (2 types of DTC) in clinical studies.

In a clinical study, CABOMETYX was given to people with differentiated thyroid cancer that had spread and progressed after prior treatment with a VEGFR-targeted/TKI medicine. These people could no longer be treated with radioactive iodine. The clinical study results were analyzed at different times.

The results of the later analysis are not based on the same type of testing as the first analysis and should not be considered conclusive.

In the first analysis

1.1, 2.1

125 people took CABOMETYX

1.1, 2.1

62 people took placebo

In the later analysis

1.1, 2.1

170 people took CABOMETYX

1.1, 2.1

88 people took placebo

Results of CABOMETYX

Proven results in the first analysis

On average, people who took CABOMETYX were able to

LIVE WITHOUT 
TUMOR GROWTH 
LONGER

In the first analysis, more than half of people who took CABOMETYX did not see their cancer get worse or spread. This means a study goal known as median progression free survival* was not yet reached.

Individual results may vary.

In the FIRST ANALYSIS, people taking CABOMETYX reduced the risk of tumor growth or death by 78% vs placebo.

The LATER ANALYSIS confirmed the results of the FIRST ANALYSIS, but was not based on the same type of testing and results are not definitive.

In the later analysis

On average, people who took CABOMETYX were able to

LIVE WITHOUT

TUMOR GROWTH

5x

longer

Median* of 11 months for CABOMETYX vs 1.9 months for placebo

Please consider that the results of the later analysis are not based on the same type of testing as the first analysis and are not definitive.

In the First analysis

More people taking CABOMETYX had a response† to treatment compared to people taking placebo

15%(10/67 people)

for CABOMETYX

vs

0%(0/33 people)

for placebo

While there was a response rate, it did not reach this goal of the study.‡

Individual results may vary.

*

Median progression free survival is the length of time from the start of treatment in a study that half the people lived without their tumors growing or spreading. Median is the middle value in a set of measurements—for some, it was shorter; for others, longer.

†

All responses were partial responses. A partial response is a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

‡

The response rate did not reach statistical significance, which is a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone.

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Side Effects

Hear a Patient and Doctor Share Their Perspectives About Side Effects

Thomas Hutson, D.O., Pharm.D., and Rosa, an actual patient, talk about the importance of knowing what to expect with side effects of CABOMETYX.

This video features a real patient and doctor to show one individual’s treatment experience with CABOMETYX. Some participants were paid for their time and expenses in sharing their story. Individual results may vary. The information in this video is not intended as medical advice. Your healthcare team is your best resource for information about your treatment. If you have any questions about your condition or treatment, contact your healthcare team.

What are the most common side effects of CABOMETYX?

Taking CABOMETYX may cause side effects. The most common side effects of CABOMETYX include: tiredness, nausea and vomiting, constipation, decreased appetite, and weight loss.

Learn about additional side effects, including serious side effects associated with CABOMETYX here.

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The BE CONNECTED support program provides educational information for you or someone you are caring for who is taking CABOMETYX.

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IMPORTANT SAFETY INFORMATION

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 for:

  • 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.

Heart problems. CABOMETYX can cause heart failure that may lead to death. Your healthcare provider may check your heart function before and during treatment with CABOMETYX. Tell your healthcare provider right away if you get any of the following signs and symptoms: feeling like your heart is pounding, racing, or beating irregularly; shortness of breath; swelling of your ankles or feet; feeling lightheaded; feeling tired.

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 with CABOMETYX 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 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.

Change in thyroid function. CABOMETYX can cause changes in your thyroid function, including changes to thyroid hormone levels in your blood. Your healthcare provider will do blood tests to check your thyroid function before and during treatment with CABOMETYX.

Decreased calcium level in your blood (hypocalcemia). CABOMETYX can cause you to have a decreased amount of calcium in your blood. Your healthcare provider will do blood tests to check you for this problem and give you calcium if needed. Tell your healthcare provider right away if you get any of the following signs or symptoms:

  • muscle stiffness or muscle spasms
  • numbness or tingling in your fingers, toes, or around your mouth
  • seizures
  • sudden weight gain
  • swelling of your arms, hands, legs, and ankles

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
  • nausea and vomiting
  • constipation
  • decreased appetite
  • weight loss

The most common side effects of CABOMETYX when used 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 of 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.
  • have a low calcium level in your blood (hypocalcemia).
  • 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 last 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 last 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.

INDICATION

What is CABOMETYX?

CABOMETYX is a prescription medicine used to treat:

  • People with kidney cancer (renal cell carcinoma). CABOMETYX may be used:
    • In combination with nivolumab to treat people with renal cell carcinoma (RCC) that has spread (advanced RCC), and you have not already had treatment for your advanced RCC.
    • Alone to treat people with advanced RCC.
  • People with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
  • Adults and children 12 years of age and older who have a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread (locally advanced or metastatic), and,
    • has progressed after treatment with a VEGFR-targeted treatment, and
    • your DTC can no longer be treated with radioactive iodine, or you are not able to receive radioactive iodine treatment.
  • Adults and children 12 years of age and older who have a type of cancer called pancreatic neuroendocrine tumors (pNET) or extra-pancreatic neuroendocrine tumors (epNET) that has been previously treated, cannot be treated by surgery, and has spread (locally advanced or metastatic).

It is not known if CABOMETYX is safe and effective in children younger than 12 years of age.

  • People with kidney cancer (renal cell carcinoma). CABOMETYX may be used:
    • In combination with nivolumab to treat renal cell carcinoma (RCC) that has spread (advanced RCC), and you have not already had treatment for your advanced RCC.
    • Alone to treat people with advanced RCC.
  • People with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
  • Adults and children 12 years of age and older who have a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread (locally advanced or metastatic), and,
    • has progressed after treatment with a VEGFR-targeted treatment, and
    • your DTC can no longer be treated with radioactive iodine, or you are not able to receive radioactive iodine treatment.
  • Adults and children 12 years of age and older who have a type of cancer called pancreatic neuroendocrine tumors (pNET) or extra-pancreatic neuroendocrine tumors (epNET) that has been previously treated, cannot be treated by surgery, and has spread (locally advanced or metastatic).

It is not known if CABOMETYX is safe and effective in children younger than 12 years of age.