Cabozantinib (ka-boe-ZAN-ti-nib)

Treats kidney, liver, and thyroid cancer.

Brand Name(s):

Cabometyx, Cometriq

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Do not substitute the tablets with the capsules.
• Tablet: Do not take with food. Take at least 1 hour before and at least 2 hours after eating.
• Capsule: Do not take with food. Do not eat at least 2 hours before and at least 1 hour after taking cabozantinib.
• Swallow the medicine whole with at least 8 ounces of water. Do not crush, break, chew, or open the medicine.
• Your doctor may give you calcium supplements if needed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • If you miss a dose and it is less than 12 hours until your next scheduled dose, skip the missed dose and take your next dose at the normal time. Do not take extra medicine to make up for the missed dose.
  • If you miss a dose and it is more than 12 hours until your next dose, take a dose as soon as you can. Then take your next dose at the scheduled time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how cabozantinib works. Tell your doctor if you are using abacavir, adefovir, atazanavir, boceprevir, carbamazepine, cidofovir, clarithromycin, conivaptan, dexamethasone, furosemide, indinavir, itraconazole, ketoconazole, lamivudine, lopinavir, nefazodone, nelfinavir, nevirapine, phenobarbital, phenytoin, posaconazole, probenecid, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, St John's wort, telithromycin, tenofovir, or voriconazole.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 4 months after your last dose.
• Do not breastfeed during treatment and for at least 4 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, blood clotting or bleeding problems, high blood pressure, thyroid problem, an open wound, or dental problems.
• This medicine may cause the following problems:
  • Severe bleeding problems
  • High blood pressure, heart attack, stroke, or blood clots
  • Increased levels of protein in your urine, which may lead to kidney damage
  • Palmar-plantar erythrodysesthesia (hand-foot skin reaction), a condition that can cause pain and blisters on your hands or feet
  • Liver problems
  • Adrenal gland problem
  • Perforation (hole) or fistula in your stomach or bowel
  • Jaw bone problems that can cause pain or sores to develop in your mouth
  • Reversible posterior leukoencephalopathy syndrome (RPLS, a central nervous system disorder)
  • Protein in the urine and kidney problems
  • Thyroid problems, including hypothyroidism
  • Hypocalcemia (low calcium in the blood)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause you to bleed more easily and cause wounds to heal slowly. Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests. You may need to stop taking this medicine for at least 3 weeks before surgery, including dental procedures. Wait for at least 2 weeks after major surgery, or until adequate wound healing before taking this medicine again.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine
• Changes in skin color, dark freckles, cold feeling, weight loss
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, fainting
• Constipation, depression, muscle cramps, weight gain, unusual tiredness or weakness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Gagging, coughing, or choking when you eat or drink
• Muscle cramps, spasms, or stiffness, numbness and tingling around the mouth, fingertips, or feet, swelling in your hands, arms, legs, or feet
• Numbness or weakness on one side of your body, sudden or severe headache, seizure, confusion, problems with vision, speech, or walking
• Rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Red or dark brown urine, bloody or black, tarry stools, unexplained nosebleeds, vomit that looks like coffee grounds
• Severe diarrhea
• Tightness in your jaw, mouth pain or numbness, loose teeth
• Unusual or heavy bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Change in hair color
• Decreased appetite, change or loss of taste
• Mild diarrhea
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088