Cabometyx is a kinase inhibitor, a type of enzyme inhibitor that blocks the action of certain protein kinases.

Cabometyx is used to treat advanced kidney cancer, sometimes in combination with another medicine called nivolumab.

Cabometyx is used to treat liver cancer (hepatocellular carcinoma) in people who have been previously treated with sorafenib.

Cabometyx is also used to treat a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread, and has progressed after treatment with a VEGFR-targeted treatment, and can no longer be treated with, or you are not able to receive radioactive iodine.

Cabometyx may cause a perforation (a hole or tear) or a fistula (an abnormal passageway) within your stomach or intestines. This medicine can also increase your risk of serious bleeding.

Call your doctor if you have: severe stomach pain, choking or gagging when you eat or drink, unusual bleeding, bloody or tarry stools, heavy menstrual bleeding, or if you cough up blood.

Before taking this medicine

To make sure Cabometyx is safe for you, tell your doctor if you have:

• a low calcium level in your blood (hypocalcemia);

• an open wound on your skin (or a wound that is still healing);

• bleeding problems (such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds);

• high blood pressure;

• liver disease; or

• a pre-existing dental problem.

You may need to have a negative pregnancy test before starting this treatment.

Cabozantinib may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Cabometyx and for at least 4 months after your last dose. Tell your doctor if you think you might be pregnant.

Cabozantinib may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Cabometyx can harm an unborn baby.

You should not breastfeed while using Cabometyx, and for at least 4 months after your last dose.

Take Cabometyx exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not use Cabometyx tablets in place of Cometriq (cabozantinib) capsules. Take only the pill form your doctor has prescribed. Avoid medication errors by always checking the medicine you receive at the pharmacy.

Take Cabometyx on an empty stomach, at least 1 hour before or 2 hours after you eat anything.

Do not take Cabometyx with food.

Take this medicine with a full glass of water.

Do not crush, chew, or break a tablet, and do not open a capsule. Swallow the pill whole.

When used with Cabometyx, nivolumab is usually given as an infusion into a vein once every 2 to 4 weeks.

Your blood pressure, thyroid, and liver function may need to be checked often.

If you need surgery or dental work, stop taking Cabometyx at least 3 weeks ahead of time. After a surgery or dental procedure, you may need to wait 2 weeks before you start taking Cabometyx again. Follow your doctor's dosing instructions very carefully.

If you have stopped taking Cabometyx for any reason, talk with your doctor before you start taking it again.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Renal Cell Carcinoma:

Tablets:
-As a single agent: 60 mg orally once a day until patient no longer experiences clinical benefit or unacceptable toxicity occurs
-In combination with nivolumab: 40 mg once a day until disease progression or unacceptable toxicity

Comment: When administering this drug in combination with nivolumab, refer to the nivolumab prescribing information.

Uses:
-For patients with advanced renal cell carcinoma (RCC)
-In combination with nivolumab, indicated for the first-line treatment of patients with advanced RCC

Usual Adult Dose for Hepatocellular Carcinoma:

Tablets: 60 mg orally once a day until patient no longer experiences clinical benefit or unacceptable toxicity occurs

Use: For patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Usual Adult Dose and Pediatric Dose for Differentiated Thyroid Cancer

-As as a single agent for adult and pediatric patients 12 years of age and older with BSA greater than or equal to 1.2 m² is 60 mg once daily until disease progression or unacceptable toxicity

-As as a single agent in pediatric patients 12 years of age and older with BSA less than 1.2 m² is 40 mg once daily until disease progression or unacceptable toxicity.

Use: locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible

To make sure Cabometyx is safe for you, tell your doctor if you have:

• a low calcium level in your blood (hypocalcemia);

• an open wound on your skin (or a wound that is still healing);

• bleeding problems (such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds);

• high blood pressure;

• liver disease; or

• a pre-existing dental problem.

You may need to have a negative pregnancy test before starting this treatment.

Cabozantinib may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Cabometyx and for at least 4 months after your last dose. Tell your doctor if you think you might be pregnant.

Cabozantinib may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Cabometyx can harm an unborn baby.

You should not breastfeed while using Cabometyx, and for at least 4 months after your last dose.

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with Cabometyx and lead to unwanted side effects. Avoid the use of grapefruit products while taking cabozantinib.

Avoid taking an herbal supplement containing St. John's wort.

Get emergency medical help if you have signs of an allergic reaction to Cabometyx: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cabometyx may cause a perforation (a hole or tear) or a fistula (an abnormal passageway) within your stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears;

• vomiting, diarrhea, or constipation that are severe and ongoing;

• swelling in your hands, arms, legs, or feet;

• easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding, or any bleeding that will not stop);

• bloody or tarry stools, cough with bloody mucus or vomit that looks like coffee grounds;

• jaundice (yellowing of the skin or eyes);

• pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet;

• confusion, thinking problems, weakness, vision changes, seizure;

• a light-headed feeling, like you might pass out;

• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;

• low blood calcium - muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• adrenal gland problems - nausea, vomiting, extreme tiredness, dizziness, weakness, fainting; or

• signs of a stroke or blood clot - sudden numbness or weakness on one side of your body, problems with vision or balance, trouble speaking or understanding what is said to you, chest pain, trouble breathing, swelling or pain in an arm or leg.

Your future doses of cabozantinib may be delayed or permanently discontinued if you have certain side effects.

Common Cabometyx side effects may include:

• tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures;

• stomach pain, nausea, vomiting, loss of appetite, diarrhea, constipation;

• pain, redness, swelling, or sores in your mouth or throat;

• trouble speaking, changes in taste;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• rash;

• pain in your muscles, bones, and joints;

• abnormal liver function tests or other blood tests;

• weight loss; or

• hair color turning lighter.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with cabozantinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.