Cabozantinib

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

Cabometyx is also used to treat liver cancer in people who have already been treated with sorafenib. Cabometyx can also be used to treat thyroid cancer in people 12 years and older.

Cometriq is used to treat thyroid cancer that has spread to other areas of the body.

Cabozantinib may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Do not use cabozantinib tablets instead of cabozantinib capsules. Take only the form your doctor has prescribed. Avoid medication errors by always checking the medicine you receive at the pharmacy.

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

Do not take this medicine 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 cabozantinib at least 3 weeks ahead of time. After a surgery or dental procedure, you may need to wait 2 weeks before you start taking cabozantinib again. Follow your doctor's dosing instructions very carefully.

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

Store at room temperature away from moisture and heat.

Cabozantinib may cause a perforation (a hole or tear) or a fistula (an abnormal passageway) in your stomach or intestines. Cabozantinib 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.

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 cabozantinib and for at least 4 months after your last dose. Tell your doctor if you think you might be pregnant.

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

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

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

Cabozantinib may cause a perforation (a hole or tear) or a fistula (an abnormal passageway) in 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.

Cabozantinib may cause serious side effects. Call your doctor right away 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 on the palms of your hands or the soles of your feet;
• confusion, thinking problems, weakness, vision changes, seizure;
• feeling light-headed, 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 stopped if you have certain side effects.

Common side effects of cabozantinib 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.

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 cabozantinib and lead to unwanted side effects. Avoid using grapefruit products while taking cabozantinib.

Avoid taking an herbal supplement that contains St. John's wort.

Sometimes, it is not safe to use certain medications at the same time. Some drugs can change the amount of other drugs in your blood, which may increase side effects or make the medications work less effectively.

Other drugs may affect 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.