Cabozantinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat kidney cancer or thyroid cancer. Take it exactly as directed.
• This medicine may cause serious internal bleeding, ulcers, or perforation of the stomach or intestines.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may interact with many other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: tyrosine kinase inhibitor; antineoplastic (anticancer)

Generic and brand names: cabozantinib, oral; Cabometyx; Cometriq

What is this medicine used for?

This medicine is taken by mouth to treat advanced kidney or thyroid cancer.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA), or a heart attack
• Blood clots or a bleeding disorder
• High blood pressure
• Liver or kidney disease
• Stomach problems such as ulcers or bleeding

Also, tell your healthcare provider if you have recently had or are scheduled to have any kind of surgery or dental work, or if you have an open wound or unusual bleeding.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use effective form of birth control during treatment with this medicine and for 4 months after your last dose. Talk with your healthcare provider about effective birth control. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

Males: Use effective birth control while you are taking this medicine and for 4 months after you stop taking the medicine. Talk with your healthcare provider about effective birth control.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your healthcare provider may adjust your dose based on your lab tests. Do not stop taking this medicine without your healthcare provider's approval. Do not miss doses or take more than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

Do not eat for at least 2 hours before and 1 hour after you take this medicine.

Swallow tablets or capsules whole with a full glass of water. Do not break, crush, or chew them.

What if I miss a dose?

If you miss a dose and it is less than 12 hours until your next dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: confusion; memory loss.

What should I watch out for?

You will need to have blood and lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause severe or life-threatening bleeding. Tell your healthcare provider right away if you have any signs of bleeding while you are taking this medicine or after you stop taking this medicine.

This medicine may also cause a serious or life-threatening tear or abnormal tunnel (fistula) in the stomach or intestines. Tell your healthcare provider right away if you have severe stomach pain or have coughing, gagging, or choking.

This medicine may increase your blood pressure. Talk with your healthcare provider about how often you should check your blood pressure.

This medicine may cause a rare, but serious disease called osteonecrosis of the jaw. You may be at an increased risk for this problem if you have any dental problems or dental surgery. Talk with your healthcare provider about this. You should brush your teeth and clean your mouth properly while taking this medicine. If you have any jaw pain, swelling, numbness, or loose teeth, contact your healthcare provider right away.

This medicine may make you tired or weak. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have taken this medicine. You may need to stop this medicine before you have any planned surgery or dental work. Your healthcare provider will tell you when you should restart this medicine after a planned surgery or dental work.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; dark urine or bowel movements; bloody urine; increased menstrual flow or vaginal bleeding; unusual tiredness or weakness; severe stomach pain, diarrhea, nausea, or vomiting; trouble eating or drinking; swelling, numbness, or tingling in fingers or toes, or any unexplained swelling; decreased urination; redness or pain in your arms or legs; jaw pain, toothache, or sore gums; yellowing of the eyes and skin; chest pain; increased sweating; shortness of breath; severe dizziness or fainting; redness, tenderness, or blisters on your hands and feet, or in your mouth; seizures; confusion, fever, cough, sore throat.

Other: Diarrhea, constipation, nausea, vomiting, change in sense of taste, weight loss, decreased appetite, tiredness, hair color changes, hair loss, hoarseness or voice changes, dry skin, joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as desipramine (Norpramin) and nefazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and nilotinib (Tasigna)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Lomitapide (Juxtapid)
• Nausea medicines such as aprepitant (Emend) and netupitant/palonosetron (Akynzeo)
• St. John's wort

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.