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, severe vomiting/diarrhea, or if you are coughing/gagging/choking when eating or drinking, or coughing up blood.
Cabozantinib is used to treat thyroid cancer (medullary type) that has spread to other parts of the body. It works by slowing or stopping the growth of cancer cells. This medication belongs to a class of drugs known as tyrosine kinase inhibitors.
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.
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.
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.
Do not touch the dust or powder from this medication. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
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.
Cabozantinib may cause or worsen high blood pressure. You may need to take medication to control high blood pressure or adjust your high blood pressure medication if you are already being treated. Check your blood pressure regularly and tell your doctor right away of high results.
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).
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.
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.
Rarely, people taking cabozantinib have had serious jawbone problems (osteonecrosis). Poor dental hygiene, poorly fitting dentures, having certain dental work (such as tooth removal, dental surgery), or also taking bisphosphonate drugs (such as alendronate) may increase your risk. Do not take cabozantinib for at least 28 days before such dental work. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. Ask your dentist how to properly care for your teeth and gums. If you develop jaw pain, tell your doctor and dentist immediately.
Before having surgery, tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Since cabozantinib can affect wound healing, discuss with your doctor about stopping this drug at least 28 days before surgery and about when you can safely restart it after surgery.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication. Therefore, male and female patients should use reliable forms of birth control during treatment and for at least 4 months after stopping treatment. Consult your doctor for more details. If you or your partner become pregnant, or think you or your partner may be pregnant, tell your doctor right away.
It is unknown if this drug passes into breast milk. However, because of the possible risk to a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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 overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
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.
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 and resume your usual dosing schedule. 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.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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