Cabozantinib capsules and tablets

What is this medicine?

CABOZANTINIB (KA boe ZAN ti nib) is a medicine that 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 renal cell cancer and hepatocellular cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not take with food. Do not cut, crush, or chew this medicine. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• bloody or black, tarry stools

• breathing problems

• changes in vision

• chest pain or chest tightness

• confusion, trouble speaking or understanding

• feeling faint or lightheaded, falls

• jaw pain, especially after dental work

• red or dark-brown urine

• redness, swelling, or sores on hands or feet

• severe headaches

• shortness of breath, chest pain, swelling in a leg

• spitting up blood or brown material that looks like coffee grounds

• stomach pain

• sudden numbness or weakness of the face, arm or leg

• sweating

• swelling of the ankles, feet, hands

• trouble swallowing

• trouble walking, dizziness, loss of balance or coordination

• unusual bruising or bleeding from the eye, gums, or nose

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

• diarrhea

• loss of appetite

• nausea, vomiting

• sore throat

• weight loss

What may interact with this medicine?

This medicine may interact with the following medications:

• atazanavir

• carbamazepine

• clarithromycin

• conivaptan

• grapefruit juice

• indinavir

• itraconazole

• ketoconazole

• nefazodone

• nelfinavir

• phenobarbital

• phenytoin

• rifabutin

• rifampin

• rifapentine

• ritonavir

• saquinavir

• St. John's Wort

• telithromycin

• voriconazole

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

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

What should I tell my health care provider before I take this medicine?

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

• bleeding disorders

• high blood pressure

• liver disease

• recent surgery

• skin conditions or sensitivity

• an unusual or allergic reaction to cabozantinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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 doctor 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. After surgery, wait at least 2 weeks 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 doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 4 months after the last dose.

This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.