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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 can you do to help manage side effects?

Let your oncology doctor or nurse know right away if you experience a side effect that bothers you or that does not go away. There are ways to help with certain side effects.

When needed, your oncology doctor or nurse may manage certain side effects by adjusting your dose. They may:

  • Pause your CABOMETYX for a while
  • Lower your CABOMETYX dose
  • Permanently stop your CABOMETYX

Pausing or lowering your dose of CABOMETYX is not unusual. Many people in the clinical trials had their dose paused or lowered to help manage certain side effects.

Remember that it's OK to contact your oncology doctor right away if you have any side effects.

Speaking up about side effects can help your doctor find the right dose of CABOMETYX for you.

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

Click the icons below for tips that may help you feel better if you have any of the following side effects. These tips have been developed based on information from a variety of organizations that provide information and support to people affected by cancer.

Ask your oncology doctor or nurse about anything you don't understand. This will help you learn more about your treatment, your treatment goals, and what you can do to help with your care.

Tips to help with diarrhea: Diarrhea

  • Drink plenty of clear liquids. Try not to drink many caffeinated drinks (such as coffee and soft drinks) and dairy products (such as milk)
  • Eat small, light meals many times a day (such as bananas, rice, applesauce, dry toast, or mashed potatoes)
  • Try not to eat foods that are spicy, greasy, fatty, or high in fiber (such as fast food, raw vegetables, and nuts)
  • Keep track of how often you have diarrhea, the amount of fluid you drink, and your weight
  • After each bowel movement, gently clean your anal area well with a mild soap or baby wipes, and pat dry. Once dry, you may apply petroleum jelly or A&D® ointment to the outer rectal area
  • Talk to your doctor about taking loperamide (anti-diarrheal tablets) to make sure it’s safe for you. Take 2 caplets after the first loose stool and 1 after each loose stool thereafter. Do not take more than 4 caplets in a 24-hour time frame

DON’T FORGET: Diarrhea, if not managed, can be very serious, so it is important to speak to your oncology doctor or nurse if you have any signs or symptoms and/or your stools are happening more often than normal.

CABOMETYX Side Effects Tips; call your oncology doctor

Call your oncology doctor or nurse right away if you:

  • Have 6 or more loose bowel movements a day for 2 days in a row
  • Have blood around the anal area or blood in your stool
  • Lose 5 or more pounds after the diarrhea starts
  • Have pain in your belly or cramps start and last for 2 or more days
  • Don't urinate for 12 or more hours
  • Get a puffy or swollen belly

Tips for mouth care:CABOMETYX Side Effect Tips; Mouth Sores

  • See your dentist regularly
    • Brush your teeth gently after each meal
    • Use a soft toothbrush and children’s toothpaste
    • Floss your teeth at least once a day
    • Tell your dentist about the treatments you are taking
  • If you have mouth sores or dryness, rinse your mouth after you eat and before you go to bed
    • Use a salt and baking soda mixture: 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 in your mouth, gently gargle, and then spit it out. Don’t swallow!
    • Do not use mouthwash with alcohol
  • Use a lip balm such as ChapStick® to keep your lips moisturized
  • If you have mouth pain
    • 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 you can swallow easily
    • Try not to eat hard, crusty, salty, sticky, sugary, or spicy foods
    • Try not to eat or drink fruits or juices that are acidic, such as tomatoes, oranges, grapefruits, limes, and lemons
CABOMETYX Side Effects Tips; call your oncology doctor

Call your oncology doctor or nurse if you have pain in your mouth or throat OR if your mouth looks or feels different.

  • Check your mouth 2 times a day. Use a small flashlight and a padded tongue depressor to:
    • Look for small cuts, ulcers, or sores in your mouth—on your gums, on your tongue, or under your tongue
    • See if the inside of your mouth is redder than usual or swollen
    • See if there is blood in your mouth

Tips to help with nausea and vomiting: CABOMETYX Side Effect Tips; Nausea and Vomiting

  • For nausea (upset stomach)
    • Drink plenty of clear liquids such as ginger ale, apple juice, and broth
    • Eat bland foods (with little to no taste) such as dry toast and crackers. Do not eat heavy, fatty meals, or greasy foods
    • Try to stay away from strong odors
    • Do not lie flat for at least 1 hour after eating. Rest by sitting up in a chair or recliner
    • Suck on lemon or mint candy to make a bad taste go away
  • Do not eat for 2 to 3 hours before you go to bed and raise the head of your bed for sleeping
  • For vomiting (throwing up what’s in your stomach)
    • Keep track of how often you are vomiting, the amount of fluid you drink each day, and your weight
    • After vomiting stops, try to slowly sip a small amount of cool liquid. You might want to suck on some ice chips or frozen juice chips

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

CABOMETYX Side Effects Tips; call your oncology doctor

Call your oncology doctor or nurse right away if you:

  • Vomit more than 3 times an hour for more than 3 hours
  • See blood in your vomit
  • Vomit and it looks like coffee grounds
  • Can't have 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 to help with fatigue (being very tired and/or feeling like you
have no energy):CABOMETYX Side Effect Tips; Fatigue

  • Get a good night's sleep each night. The right amount varies by person, but is usually around 7 to 8 hours
  • Try to keep good sleep habits
    • Go to bed at the same time each night
    • Wake up at the same time each day
  • Try not to eat heavy meals before bedtime
  • If you have caffeine, make sure it's 6 to 8 hours before you go to bed. Remember, caffeine is in liquids (such as soft drinks and coffee), food (such as chocolate), and some medicines
  • Make sure your bedroom is quiet and dark and is a comfortable temperature
  • Be as active as possible. Talk with your doctor about which types of activity may be right for you. It is best to start slowly. Only do more when you know you're able to
  • Plan ahead. Decide which activities are most important to you. Try to schedule important activities 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
CABOMETYX Side Effects Tips; call your oncology doctor

Call your oncology doctor or nurse right away if you:

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

Tips to help take care of hand-foot syndrome: CABOMETYX Side Effect Tips; Hand-Foot Syndrome

Certain medications used to treat cancer may cause HFS, which is a side effect that causes symptoms such as pain, swelling, and numbness. You may also hear your doctor call HFS palmar-plantar erythrodysesthesia syndrome (PPES).

  • Heat may make your symptoms worse or more likely to happen
  • Try not to put your hands or feet in hot water
  • Try to stay out of direct sunlight or other heat sources
  • If your hands and feet feel hot, use an ice pack for 15 to 20 minutes to cool them
  • Take cool showers or baths
  • Don’t take hot showers
  • Try to avoid pressure, friction, or rubbing
  • Don’t use hammers, shovels, knives, or other tools
  • Wear loose clothing and comfortable, well-fitting footwear
  • Gently pat your skin dry after washing your hands or bathing
  • Use cotton gloves and socks to help protect your hands and feet
  • Talk to your doctor about using creams such as clobetasol and halobetasol—these can be found at your local drug store
CABOMETYX Side Effects Tips; call your oncology doctor

Tell your oncology doctor or nurse if you have any of the following problems with your hands or feet:

  • Your skin is red or swelling
  • 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)

Tips to help with high blood pressure: CABOMETYX Side Effect Tips; High Blood Pressure

  • Take your blood pressure regularly. Talk to your doctor before you get started
  • Be healthy!
    • Eat a diet of whole grains, fruits, vegetables, and low-fat dairy products (such as yogurt)
    • Don't have too much salt, caffeine, or alcohol
  • Exercising regularly can help with blood pressure. Examples of the best types of exercise include walking, jogging, cycling, or swimming. You may want to talk to your oncology doctor about what types of exercise he or she may recommend for you
CABOMETYX Side Effects Tips; call your oncology doctor

Call your oncology 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

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.