Brand Name(s):

Cabometyx^®

WHY is this medicine prescribed?

Cabozantinib (Cabometyx) is used to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the cells of the kidneys). It is also used to treat hepatocellular carcinoma (HCC; a type of liver cancer) in people who were previously treated with sorafenib (Nexafar). Cabozantinib (Cabometyx) 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.

Cabozantinib is also available as a capsule (Cometriq) to treat a certain type of thyroid cancer. This monograph only gives information about cabozantinib tablets (Cabometyx) for advanced RCC. If you are using this medication for thyroid cancer, read the monograph entitled cabozantinib (thyroid cancer).

HOW should this medicine be used?

Cabozantinib (Cabometyx) comes as a tablet to take by mouth. It is usually taken once a day on an empty stomach, at least 1 hour before and 2 hours after eating. Take cabozantinib (Cabometyx) 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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cabozantinib (Cabometyx) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

Your doctor may decrease your dose of cabozantinib (Cabometyx) 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 (Cabometyx).

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

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking cabozantinib (Cabometyx),

tell your doctor and pharmacist if you are allergic to cabozantinib (Cabometyx, Cometriq), any other medications, or any of the ingredients in cabozantinib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take. Be sure to mention any of the following: boceprevir (Victrelis), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), clarithromycin (Biaxin, in Prevpac), conivaptan (Vaprisol), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole, nefazodone, nelfinavir (Viracept), phenobarbital, phenytoin (Dilantin, Phenytek), posaconazole (Noxafil), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifamate, Rifater), rifapentine (Priftin), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), telithromycin (Ketek), and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with cabozantinib (Cabometyx), so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
tell your doctor what herbal products you are taking, especially St. John's wort.
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, or if you have an open or healing wound, or if you have or have ever had 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 (Cabometyx), call your doctor immediately.
tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment 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 (Cabometyx).
if you are having surgery, including dental surgery or a dental procedure tell the doctor or dentist that you are taking cabozantinib (Cabometyx). Your doctor will probably tell you to stop taking cabozantinib (Cabometyx) at least 28 days before your surgery or procedure, and will tell you when you should start taking the medication again.
you should know that cabozantinib (Cabometyx) 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 (Cabometyx).
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?

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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 athttps://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 (Cabometyx).

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2019.