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Learn about CABOMETYX

What is CABOMETYX?

CABOMETYX is a kind of medication called a tyrosine kinase inhibitor (TKI). It is given as a tablet.

It is used to treat:

People with advanced kidney cancer alone or in combination with a medicine called OPDIVO® (nivolumab) if you have not already had treatment

How CABOMETYX may help

CABOMETYX is proven to help certain people with advanced kidney cancer in clinical studies.

CABOMETYX in combination with OPDIVO

In a clinical study, CABOMETYX was given to people with advanced kidney cancer as a first treatment (your doctor may call it “first-line treatment”), with another medicine, OPDIVO. Other people in the study received a different medicine, sunitinib.*

People stayed on treatment until their tumors started to grow, or they had a side effect that could not be managed.

In the study:

323 people took CABOMETYX (orally) + OPDIVO (infusion)

328 people took sunitinib (orally)

The clinical study results were analyzed at different times.

The first analysis was done to support approval of CABOMETYX + OPDIVO as a combination treatment for people with advanced kidney cancer who have not had prior treatment.

This clinical study looked at people's results at a median^† of 18.1 months.

A later analysis, which is typical for clinical studies, looked at people's results at a median^† of 44 months.

Each person's results with CABOMETYX may be different.

Proven results with CABOMETYX + OPDIVO

In the first analysis

In the later analysis

More people
Were alive at 2 years

70% for CABOMETYX + OPDIVO vs 61% for sunitinib

4+ Years
Median^† overall survival

Median^† of 49.5 months for CABOMETYX + OPDIVO vs 35.5 months for sunitinib

In the first analysis

People were able to

Live 2x longer without tumor growth

Median^† of 16.6 months for CABOMETYX + OPDIVO vs 8.3 months for sunitinib (based on people's results at a median^† of 18.1 months)

In the later analysis

People were able to

Live almost 2x longer without tumor growth

Median^† of 16.6 months for CABOMETYX + OPDIVO vs 8.4 months for sunitinib (based on people's results at a median^† of 44 months)

In both analyses, CABOMETYX + OPDIVO helped people live longer without their cancer progressing.

In the first analysis

Tumors shrunk in size in 2x as many people

55.7% CABOMETYX + OPDIVO vs 27.1% sunitinib (complete + partial responses)

Tumors disappeared completely in almost 2x as many people

8% CABOMETYX + OPDIVO vs 4.6% sunitinib (complete responses)

More than twice as many people taking CABOMETYX + OPDIVO had a partial response (48%) vs people taking sunitinib (23%).

In the later analysis

Tumors shrunk in size in 2x as many people

56% CABOMETYX + OPDIVO vs 28% sunitinib (complete + partial responses)

Tumors disappeared completely in almost 2x as many people

13.3% CABOMETYX + OPDIVO vs 4.9% sunitinib (complete responses)

Almost twice as many people taking CABOMETYX + OPDIVO had a partial response (42.7%) vs people taking sunitinib (23.2%).

In the later analysis, the number of people who had their tumors disappear completely increased from the first analysis.

Each person's results with CABOMETYX may be different.

*: Sunitinib is a prescription medicine used to treat adults with advanced kidney cancer.
^†: Median is the middle value in a set of measurements—for some, it was shorter; for others, longer.
^‡: "Meaningful reductions" is defined as the combination of complete response (the disappearance of signs of cancer in response to treatment; this does not necessarily mean the cancer has been cured), and partial response (a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment).

CABOMETYX alone as a first treatment for advanced kidney cancer

CABOMETYX was proven to help certain people with advanced kidney cancer live longer without their tumor progressing.

CABOMETYX was compared with a medicine called sunitinib* in a clinical study of people with advanced kidney cancer. All people in the study had one or more established risk factors and had not previously received medicine to treat their cancer.

In the study:

79 people took CABOMETYX

78 people took sunitinib

People stayed on treatment until their  tumor  started to grow again or they had a side effect that could not be managed.

Each person’s results with CABOMETYX may be different.

Results showed that:

People were able to
Live longer without tumor growth

Median^† of 8.6 months vs 5.3 months for sunitinib

*: Sunitinib is a prescription medication used to treat adults with advanced kidney cancer.
^†: Median is the middle value in a set of measurements—for some, it was shorter; for others, longer.

CABOMETYX if you have been treated before for advanced kidney cancer

CABOMETYX was proven to help certain people with advanced kidney cancer in a clinical study

People had taken at least one other medicine to treat their advanced kidney cancer before taking CABOMETYX.

People stayed on treatment until their  tumors  started to grow or they had a side effect that could not be managed.

In the study:

330 people took CABOMETYX

328 people took a medicine called everolimus*

Each person’s results with CABOMETYX may be different.

The results showed:

People were more likely to
Live longer

Median^† of 21.4 months vs 16.5 months for everolimus

People were more likely to
Live almost 2x longer without tumor growth

Median^† of 7.4 months vs 3.8 months for everolimus

Tumors shrunk in size for 5x more people

17% for CABOMETYX vs 3% for everolimus. In the clinical study, the tumor had to shrink by at least 30% and had to be confirmed by a second scan

*: Everolimus is a prescription medicine used to treat adults with advanced kidney cancer when certain other medicines have not worked.
^†: Median is the middle value in a set of the measurements—for some, it was shorter; for others, longer.

Talking to Your Doctor

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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, decreased appetite, nausea and vomiting, weight loss, and constipation.

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, and upper respiratory tract infection.

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

LEARN MORE ABOUT

Patient Brochure
Download this resource to learn more about CABOMETYX, and help you discuss with your doctor if it is right for you.

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

OPDIVO® and the related logo are registered trademarks of Bristol-Myers Squibb Company.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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 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 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
Decreased appetite
Nausea and vomiting
Weight loss
Constipation

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 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.

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 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 renal cell carcinoma (RCC) that has spread (advanced RCC)

Learn about CABOMETYX

What is CABOMETYX?

How CABOMETYX may help

Proven results with CABOMETYX + OPDIVO

In the first analysis

Results showed that:

The results showed:

Side Effects

Hear a Patient and Doctor Share Their Perspectives About Side Effects

What are the most common side effects of CABOMETYX?

LEARN MORE ABOUT

INDICATIONS AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, including:

What should I avoid while taking CABOMETYX?

INDICATION

What is CABOMETYX?

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