cabozantinib

What is the most important information I should know about cabozantinib?

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

What is cabozantinib?

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

Cabometyx is also used to treat liver cancer in people who have been previously 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 parts of the body.

Cabozantinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking cabozantinib?

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.

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.

How should I take cabozantinib?

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 in place of cabozantinib capsules. Take only the pill form your doctor has prescribed. Avoid medication errors by always checking the medicine you receive at the pharmacy.

Do not take this medicine with food.

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.

What happens if I miss a 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.

What happens if I overdose?

What should I avoid while taking cabozantinib?

Grapefruit may interact with cabozantinib 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.

What are the possible side effects of cabozantinib?

Cabozantinib 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.

• 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 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.

What other drugs will affect cabozantinib?

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 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.

Where can I get more information?

Your pharmacist can provide more information about cabozantinib.