Cabometyx contains the active ingredient cabozantinib in the form of cabozantinib (S)-malate salt, which is a kinase inhibitor. It is available as film-coated tablets for oral administration in strengths of 20 mg, 40 mg, and 60 mg. Key inactive ingredients include microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, and a film coating that includes hypromellose and titanium dioxide.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it on an empty stomach, at least 1 hour before and 2 hours after food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Diarrhea
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth
• Redness, swelling, and blistering of the skin over hands and feet
• Stomach pain that is severe, does not go away, or gets worse
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

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

• Change in hair color
• Constipation
• Fatigue
• Loss of appetite with weight loss
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

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

• Bleeding disorder
• Having or recent dental work
• Having or recent surgery
• High blood pressure
• Liver disease
• Low levels of clacium in the blood
• Thyroid disease
• An unusual or allergic reaction to cabozantinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Certain antibiotics, such as clarithromycin, telithromycin, rifampin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as ketoconazole, itraconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Furosemide
• Grapefruit juice
• Nefazodone
• Probenecid
• St. John's wort

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication 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 care team tells you to stop.

Before having surgery or dental work, talk to your care team to make sure it is ok. This medication can increase the risk of poor healing of your surgical site or wound. You will need to stop this medication for 3 weeks before surgery or dental work. After surgery, wait at least 2 weeks before restarting this medication. Make sure the surgical site or wound is healed enough before restarting this medication. Talk to your care team if questions.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

This medication may increase your risk for jaw problems. Tell your care team right away if you have severe pain in your jaw. Tell your care team if you have any pain that does not go away or that gets worse.

Talk to your care team if you may be pregnant. Serious birth defects can occurs if you take this medication during pregnancy and for 4 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 4 months after the last dose. You care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 4 months after the last dose.

This medication may make cause infertility. Talk to your care team if you are concerned about your fertility.