Side Effects | CABOMETYX® (cabozantinib)

Your healthcare team is your best resource

Your doctor, nurse, or member of your healthcare team can help you manage certain side effects. How you feel is important to them and they want to offer additional support if you need it.

No concern is too small to bring to their attention. They are available to help you.

If you have any concerns or are not feeling well, reach out to them right away.

We have an approach called AIM to help you share information with your healthcare team

A
ACKNOWLEDGE
if you are feeling different; this may be a symptom of a side effect
I
INFORM
your healthcare team right away
M
MANAGE
side effects by working with your healthcare team

The sooner you share information, the sooner your healthcare team can help you manage certain side effects. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with CABOMETYX^® if you have certain side effects. Please note that not all side effects can be managed, and some may lead to permanent discontinuation of the medicine.

CABOMETYX can cause side effects

Side effects can happen at any time, including within the first few weeks of starting treatment with CABOMETYX.

Tell your doctor or nurse right away if you have a side effect that bothers you or does not go away. Below are some select side effects that may occur while taking CABOMETYX:

If you are taking CABOMETYX + OPDIVO® (nivolumab), you may also experience side effects from OPDIVO and need to discuss what they are with your doctor or nurse.

The most common side effects of the combination were 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, or upper respiratory tract infection.

Scroll down to learn more about tips to manage certain side effects.

What can you do to help manage certain side effects?

Your healthcare team has options to manage certain side effects.

Your doctor or nurse may:

Lower your CABOMETYX dose

Temporarily stop your CABOMETYX dose

Permanently stop your CABOMETYX dose

Your doctor or nurse may also recommend lifestyle changes and other medicines to help with certain side effects.

Please note that not all side effects can be managed, and some may lead to permanent discontinuation of the medicine.

Tips to help manage certain side effects of CABOMETYX

These tips are not a substitute for medical advice by your healthcare team.

DIARRHEA

Diarrhea, if it is not managed, can be very serious.

If you have any signs and symptoms and/or your stools are happening more often than normal, contact your healthcare team.

Remember AIM and call your doctor or nurse right away if you:

Have any increase in bowel movements (4 - 6 additional episodes per day)
Have blood around the anal area or in your stool
Lose 5 or more pounds after the diarrhea starts
Have pain in your belly or cramps that start and last for 2 or more days
Don’t urinate for 12 or more hours
Get a puffy or swollen belly

TIPS TO HELP WITH DIARRHEA

Do

Drink plenty of clear liquids
Eat small, light meals many times a day (such as bananas, rice, applesauce, dry toast, or mashed potatoes)
Keep track of how often you have diarrhea, the amount of fluid you drink, and your weight

Avoid

Caffeinated drinks (such as coffee and soft drinks) or dairy products (such as milk)
Spicy, greasy, fatty, or high-fiber foods (such as fast food, raw vegetables, and nuts)

Loperamide (anti-diarrheal) tablets are included in the Patient Care Kit, which you may have received from your doctor or, if eligible*, you can order here.

Talk with your doctor about taking loperamide to make sure it’s safe for you.

*Terms and Conditions apply.

ORAL (MOUTH) CARE

Certain medications used to treat cancer may cause mouth problems such as:

Canker sores
Gum or mouth pain
Infections in your mouth or gums
Burning sensation of the tongue
Red, swollen, or bleeding gums
Change in how things taste

Remember AIM and call your doctor or nurse right away if you notice anything unusual.

Check your mouth 2 times a day
Look for small cuts, ulcers, sores, redness, swelling, or blood

TIPS FOR ORAL CARE

Do

Discuss plans for dental procedures with your healthcare team
See your dentist regularly and tell them about the treatments you are taking
Brush teeth regularly after each meal (use a soft toothbrush and children’s toothpaste)
Floss your teeth at least once a day
Keep your lips moisturized with a lip balm
Rinse your mouth regularly with salt and baking soda mixture if you experience sores or dryness. Add 1 teaspoon of salt and 1 teaspoon of baking soda to 1 quart of warm water; stir or shake well. Sip the solution, swish it around and gently gargle, and then spit it out. Do not swallow.

Avoid

Using mouthwash made with alcohol

If you experience mouth pain

Do

Suck on ice chips or ice pops
Drink through a straw
Talk to your oncology doctor about over-the-counter medications that can be used for the pain
Eat soft foods that can be swallowed easily

Avoid

Hard, crusty, salty, sticky, sugary, or spicy foods
Fruits or juices that are acidic, such as tomatoes, oranges, grapefruits, limes, and lemons

NAUSEA AND VOMITING

You may feel nauseous (queasy) or vomit (throw up) during your cancer treatment.

Remember AIM and call your doctor or nurse right away if you:

Vomit more than 3 times an hour for more than 3 hours
See blood in your vomit
Your vomit looks like coffee grounds
Can not tolerate more than 4 cups of liquid or ice chips in a day
Haven’t been able to eat for more than 2 days
Are weak, dizzy, or confused
Lose 2 or more pounds in 2 days
Have dark-yellow urine

TIPS FOR MANAGING NAUSEA AND VOMITING

Do

Drink plenty of clear liquids (such as ginger ale, apple juice, or broth)
Eat bland foods—with little to no taste (such as dry toast and crackers). Suck on lemon or mint candy to make a bad taste go away
Raise the head of your bed for sleeping

Avoid

Heavy, fatty, greasy foods
Strong odors
Lying flat for at least 1 hour after eating
Eating for 2 to 3 hours before you go to bed

For vomiting (throwing up what’s in your stomach)

Do

Keep track of how often you are vomiting, the amount of fluid you drink, and your weight
After vomiting stops, slowly sip a small amount of cool liquid and suck on some ice chips or frozen juice chips

Your doctor may also prescribe a medication for nausea and vomiting.

Queasy Drops®^†, are included in the Patient Care Kit, which you may have received from your doctor or, if eligible^‡, you can order here.

They have ingredients that may help stop nausea and dry mouth. Talk to your doctor before using.

^†Queasy Drops is a registered trademark of Three Lollies, LLC.
^‡Terms and Conditions apply.

FATIGUE

Fatigue, or feeling tired, weak, or lacking energy is a common side effect of certain cancer treatments.

Remember AIM and call your doctor or nurse right away if you:

Are too tired to get out of bed for 24 hours or more
Can’t think clearly
Can’t sleep at night
Feel tired (out of breath or heavy/fast heartbeat) after doing small activities

TIPS FOR MANAGING FATIGUE

Do

Get a good night’s sleep each night (7 to 8 hours)
Keep good sleep habits (go to bed at the same time each night and wake up at the same time each day)
Sleep in a quiet and dark bedroom with a comfortable temperature
Be as active as possible. It’s best to start slowly. Only do more when you are able to. Talk to your doctor for tips
Plan ahead. Decide which activities are most important to you and schedule them throughout the day, if possible so you can take breaks
Eat a nutritious and well-balanced diet (make sure you have enough calories and protein to give your body the energy it needs)
Consider meeting with a registered dietitian who specializes in helping people with cancer

Avoid

Heavy meals before bedtime
Caffeine close to bedtime. If you have caffeine, make sure it is 6 to 8 hours before going to bed. Caffeine can be in liquids (such as soft drinks and coffee), food (such as chocolate), and some medicines

HAND-FOOT SYNDROME (HFS)

HFS is a side effect that causes symptoms such as pain and swelling in your hands or feet. This can be severe.

You may also hear your doctor call HFS palmar-plantar erythrodysesthesia syndrome (PPES).

Remember AIM and call your doctor or nurse right away if you notice anything unusual such as:

Your skin is red or swollen
You feel tingling/burning or your skin is sensitive to touch
You have thick calluses or blisters
Your skin is cracked, flaking, or peeling
Your skin has blisters, ulcers, or sores
You have a hard time walking or using your hands (especially if it’s because of pain)

Start using Udderly Smooth®^§ Extra Care Cream, which you may have received from your doctor or, if eligible^||, can order here.

Follow package directions or use as directed by your doctor.

Talk to your doctor about using drugstore creams such as clobetasol and halobetasol.

^§Udderly Smooth is a registered trademark of Redex Industries, Inc.
^||Terms and Conditions apply.

TIPS TO HELP WITH HAND-FOOT SYNDROME

Do

Use an ice pack if your hands and feet feel hot (cool for 15-20 minutes)
Take cool showers or baths
Wear loose and comfortable clothing, well-fitting footwear, cotton gloves and socks to help protect your hands and feet
Gently pat your skin dry after washing your hands or bathing
Use mild, fragrance-free lotions

Avoid

Heat (hot water, hot showers and baths, direct sunlight, or other heat sources). Heat may make your symptoms worse or more likely to happen
Pressure, friction, or rubbing
Using hammers, shovels, knives, or other tools

HYPERTENSION (HIGH BLOOD PRESSURE)

It is important to take your blood pressure before you start taking your medicine and regularly during your treatment.

Keep a record of your blood pressure measurements so you can tell your doctor if there is a change. Hypertension can be severe.

Remember AIM and call your doctor or nurse right away if:

Your blood pressure suddenly goes up
Your blood pressure is outside the recommended range (normal blood pressure is 120/80). Talk to your doctor about your blood pressure goals
You feel dizzy
You have shortness of breath
You have any new or worsening symptoms (eg, headaches, chest pains, visual changes)

TIPS TO HELP WITH HYPERTENSION

Do

Talk to your doctor about how to take your blood pressure regularly
Eat healthy (whole grains, fruits, vegetables, and low-fat dairy products such as yogurt)
Exercise regularly
- Walking, jogging, cycling, or swimming are the best types of exercises that can help with blood pressure
- Talk to your doctor about what types of exercise he or she may recommend for you

Avoid

Too much salt, caffeine, or alcohol

Please note not all side effects can be managed, and some may lead to permanent discontinuation of medicine.

The information on this website is not a substitute for medical advice from your healthcare team.

Please note: These tips are based on information from a variety of organizations that provide information and support to people affected by cancer.

None of the products referenced in these tips are owned by Exelixis, Inc. or its affiliates. These tips are not endorsing those products and the manufacturers of those products have not endorsed these tips. Other similar products may be used.

OPDIVO^® and the related logo is a registered trademark of Bristol-Myers Squibb Company.

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.
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.

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

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.

INDICATIONS

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.
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.

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

IMPORTANT SAFETY INFORMATION

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, 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

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

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.

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.

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.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, including:

SEE INDICATIONS

INDICATIONS

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.
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.

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

IMPORTANT SAFETY INFORMATION

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, 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

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

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.

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.

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.