Cabometyx

Read the Patient Information Leaflet if available from your pharmacist before you start taking cabozantinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Since different forms of this medication (capsules, tablets) are used to treat different types of cancer, do not change forms of this medication unless directed by your doctor.

Take this medication by mouth as directed by your doctor, usually once daily. Do not take with food. Take it on an empty stomach. Do not eat for at least 2 hours before your dose and at least 1 hour after taking it.

Swallow this medication whole with a full glass of water (8 ounces/240 milliliters). Do not open or crush the capsules or tablets.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

See also Warning section.

Dizziness, diarrhea, nausea, vomiting, mouth sores, constipation, stomach pain, tiredness, weakness, weight loss, decreased appetite, taste changes, hoarseness, and lightening of hair color may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including: redness/pain/swelling/blisters on the palms of your hands or soles of your feet, frothy urine, swelling of the hands/feet, signs of a low calcium blood level (such as severe muscle spasms, mental/mood changes, seizures), symptoms of a jawbone problem (such as jaw pain, toothache, gum sores).

Cabozantinib may also rarely cause a serious brain condition. Get medical help right away if you develop headaches, seizures, vision changes, confusion, or problems thinking.

This medication may rarely cause serious problems (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism) from blood clots. Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of your body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling in your arms/legs, tingling/weakness/numbness in your face/arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking cabozantinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, recent bleeding (including recently coughing up blood), high blood pressure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Cabozantinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water. It may also be best to eat soft, moist foods.

Some people taking cabozantinib may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having any surgery (especially dental work), tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking cabozantinib at least 28 days before surgery. Follow all instructions about stopping or starting this medication.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using cabozantinib. Cabozantinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 4 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to a nursing infant, breast-feeding while using this drug and for 4 months after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of cabozantinib from your body, which may affect how cabozantinib works. One example is St. John's wort, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Missed Doses:

If you miss a dose, take it as soon as you remember if it is more than 12 hours before the next dose. If it is less than 12 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Notes:

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure, mouth exams, urine protein) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.