Cabozantinib

WHY is this medicine prescribed?

Cabozantinib is used to treat certain types of renal cell carcinoma (RCC; a type of kidney cancer), hepatocellular carcinoma (HCC; a type of liver cancer), thyroid cancer, pancreatic neuroendocrine tumors (a type of tumor that begins in certain cells in the pancreas), and other neuroendocrine tumors (tumors that form from certain cells in the body). Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cabozantinib comes as a tablet and a capsule to take by mouth. Take once a day on an empty stomach, at least 1 hour before and 2 hours after eating. Take cabozantinib at around the same time every day. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Take cabozantinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets and capsules whole with a full glass (8 ounces, 240 mL) of water. Do not split, chew, crush, or open them.

Your doctor may decrease your dose of cabozantinib or permanently or temporarily stop your treatment if you experience serious side effects. Be sure to talk to your doctor about how you are feeling during your treatment with cabozantinib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking cabozantinib,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take while taking cabozantinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with cabozantinib: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking cabozantinib. Do not start this medication while taking cabozantinib without discussing with your healthcare provider.

• tell your doctor if you have recently had any unusual or severe bleeding such as coughing up blood, vomiting blood, or bloody or black tarry stools. Also tell your doctor if you have an open or healing wound, or if you have or have ever had a low level of calcium in your blood, thyroid problems, high blood pressure, or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you start treatment with cabozantinib. You should not become pregnant during your treatment and for 4 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking cabozantinib, call your doctor immediately. Cabozantinib may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with cabozantinib and for 4 months after your final dose.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking cabozantinib.

• if you are having surgery, tell the doctor that you are taking cabozantinib. Your doctor will probably tell you to stop taking cabozantinib at least 21 days before the surgery. If you have recently had surgery, your doctor may tell you not to take cabozantinib until at least 14 days have passed and the area has completely healed.

• you should know that cabozantinib may cause serious problems with your jaw. A dentist should examine your teeth before you start to take cabozantinib and regularly during your treatment. Be sure to brush your teeth and clean your mouth properly while you are taking cabozantinib. Talk to your doctor before having any dental treatments while you are taking this medication. Your doctor will probably tell you to stop taking cabozantinib at least 21 days before dental surgery.

• you should know that your blood pressure may increase during your treatment with cabozantinib. Your doctor will probably monitor your blood pressure before and during your treatment.

What SPECIAL DIETARY instructions should I follow?

Do not drink grapefruit juice or eat grapefruit or any foods or supplements that contain grapefruit or grapefruit juice while you are taking this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is less than 12 hours until your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Cabozantinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• nausea
• vomiting
• heartburn or indigestion
• difficulty swallowing
• change in ability to taste food
• hemorrhoids
• redness, swelling, sores, or pain in your mouth or throat
• dry mouth
• loss of appetite
• weight loss
• anxiety
• tiredness or weakness
• pale skin
• dry skin
• patchy thickening of the skin
• pain in joints, arms, or legs
• voice changes or hoarseness
• hair loss
• hair color turning lighter or gray
• slowed wound healing

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• coughing up blood or blood clots; vomiting material that is bloody or looks like coffee grounds; menstrual bleeding that is heavier than usual; red or black, tarry stools; or unusual or heavy bleeding or bruising
• diarrhea
• tender or painful stomach area
• swelling around eyes, arms, hands, legs, feet, or ankles
• foamy urine
• chest pain, pressure, or tightness; shortness of breath or cough; unusual sweating; or swelling or pain in your arms or legs
• fast, pounding, or irregular heartbeat; trouble breathing; chest pain; sudden severe headache; nose bleed; vision changes; tiredness; confusion; or blood in urine
• lightheadedness or fainting; dizziness; loss of balance or coordination; numbness or weakness of the face, arm, or leg on one side of your body; sudden trouble walking; sudden difficulty thinking, speaking, or understanding; or sudden vision problems
• vision changes, confusion, headache, seizures, or difficulty thinking
• jaw pain, toothache, loosening of the teeth, or swollen or painful gums
• rash
• redness, pain, swelling, or blistering on the palms or the soles
• extreme tiredness, dizziness, fainting, weakness, nausea, or vomiting
• yellowing of skin or eyes, extreme tiredness, bleeding or bruising easily, nausea or vomiting, right sided-stomach pain, dark colored urine, decreased appetite
• muscle stiffness or spasms; numbness, burning, or tingling in the hands, arms, feet, legs, or around the mouth; sudden weight gain; seizures; or swelling of your arms, hands, legs, and ankles

Cabozantinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• memory loss
• confusion
• weight loss

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to cabozantinib.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.