Cabozantinib capsules and tablets

What is this medication?

CABOZANTINIB (KA boe ZAN ti nib) targets proteins in cancer cells and stops the cancer cell from growing. The capsules are used to treat thyroid cancer; the tablets are used to treat hepatocellular cancer, renal cell cancer, and thyroid cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Cabometyx, COMETRIQ

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Addison's disease
• bleeding disorder
• blood clots
• high blood pressure
• liver disease
• low adrenal gland function
• low levels of calcium in the blood
• protein in your urine
• recent surgery
• skin conditions or sensitivity
• thyroid disease
• an unusual or allergic reaction to cabozantinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medicine. Swallow the tablets or capsules whole. Take it on an empty stomach, at least 1 hour before and 2 hours after food. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 12 for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

This medicine may interact with the following medications:

• certain antibiotics like clarithromycin or telithromycin
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, or phenytoin
• conivaptan
• grapefruit juice
• rifabutin
• rifampin
• rifapentine
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

Before having surgery or dental work, talk to your health care provider to make sure it is ok. This drug can increase the risk of poor healing of your surgical site or wound. You will need to stop this drug for 3 weeks before surgery or invasive dental procedures. After surgery, wait at least 2 weeks before restarting this drug. Make sure the surgical site or wound is healed enough before restarting this drug. Talk to your health care provider if questions.

Do not become pregnant while taking this medicine or for 4 months after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 4 months after stopping it.

This medicine may make it more difficult to get pregnant or father a child. Talk to your health care provider if you are concerned about your fertility.

This medicine may increase your risk to bruise or bleed. Call your health care provider if you notice any unusual bleeding.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

This medicine may increase your risk for jaw problems. Tell your health care provider right away if you have severe pain in your jaw. Tell your health care provider if you have any pain that does not go away or that gets worse.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• jaw pain, especially after dental work
• light colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired; yellowing of the eyes or skin)
• low adrenal gland function (nausea; vomiting; loss of appetite; unusually weak or tired; dizziness; low blood pressure)
• low calcium levels (fast heartbeat; muscle cramps or pain; pain, tingling, or numbness in the hands or feet; seizures)
• redness, blistering, peeling, or swelling of the skin on the palms of your hands or soles of your feet
• stomach pain
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm, or leg; trouble walking; dizziness; loss of balance or coordination)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in taste
• diarrhea
• mouth sores
• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.