cabozantinib 40 mg tablet

Generic name:
Cabozantinib - oral

Pronunciation
(KA-boe-ZAN-ti-nib)

Brand name(s)
Cabometyx , Cometriq

This medication is used to treat various types of cancer (including kidney, thyroid, liver cancer). Cabozantinib belongs to a class of drugs known as tyrosine kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

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, response to treatment, and other medications you may be taking. Children's dosage is based on body size. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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.

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 last or get worse, tell your doctor or pharmacist promptly.

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

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Cabozantinib may rarely cause serious, possibly fatal, stomach/abdominal side effects such as a hole in the gut wall (perforation) or an abnormal tunnel or connection in your body (fistula). It can also rarely cause serious, possibly fatal, bleeding. Do not take this medication if you have serious bleeding. Get medical help right away if you have unusual or easy bruising/bleeding, signs of stomach/intestinal bleeding (such as bloody/black/tarry stools, stomach/abdominal pain, bloody vomit, vomit that looks like coffee grounds), fever, chills, sudden/severe back pain, severe vomiting/diarrhea, or if you are coughing/gagging/choking when eating or drinking, or coughing up blood.

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
• cold intolerance
• slow heartbeat
• 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)
• poor wound healing
• signs of liver problems (such as yellowing eyes/skin, dark urine)

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 from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• chest/jaw/left arm pain
• unusual sweating
• sudden/severe headaches
• weakness on one side of the body
• confusion
• trouble speaking
• sudden vision changes
• shortness of breath/rapid breathing
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf

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 sore throat that doesn't go away, fever, chills, cough).

When used with the medication nivolumab, cabozantinib may cause your adrenal glands not to work well. Tell your doctor right away if you have any signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

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 coughing up/vomiting blood, bloody/black/tarry stools)
• high blood pressure
• blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels)
• open wounds

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Cabozantinib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using cabozantinib before having any immunizations/vaccinations. 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 often 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 3 or 4 weeks before surgery. This medication may cause wounds to heal more slowly. Follow all instructions about when to stop or restart this medication.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using cabozantinib. Cabozantinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 4 months after the last dose. 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 the infant, breastfeeding is not recommended while using this drug and for 4 months after the last dose. Consult your doctor before breastfeeding.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, mouth exams, urine protein, liver/thyroid function, calcium blood levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. 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.

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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.