Pronunciation: KA boe ZAN ti nib

Brand: Cabometyx, Cometriq

What is the most important information I should know about cabozantinib?

Cabozantinib can increase your risk of serious bleeding. Stop using cabozantinib and call your doctor at once if you have severe stomach pain, bloody or tarry stools, coughing up blood, or any heavy or unusual bleeding.

Some people taking cabozantinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

What is cabozantinib?

Cabozantinib interferes with the growth of some cancer cells.

Cabozantinib is used to treat thyroid cancer that has spread to other parts of the body.

Cabozantinib is also used to treat kidney cancer after other cancer medicines have been tried without success.

Cabozantinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking cabozantinib?

You should not use cabozantinib if you are allergic to it.

To make sure cabozantinib is safe for you, tell your doctor if you have:

  • high blood pressure;
  • liver disease;
  • an open wound or sore on your skin;
  • a bleeding or blood-clotting disorder;
  • a pre-existing dental problem;
  • if you have recently had surgery or dental work; or
  • if you have recently had any unusual or heavy bleeding.

Cabozantinib can harm an unborn baby.

  • If you are a woman, do not take cabozantinib if you are pregnant.
  • If you are a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is taking cabozantinib.
  • Use birth control to prevent pregnancy while you are receiving cabozantinib, whether you are a man or a woman. Keep using birth control for at least 4 months after treatment ends.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking cabozantinib.

It is not known whether cabozantinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine, and for at least 4 months after your last dose.

How should I take cabozantinib?

Cabozantinib is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Cabozantinib is available in tablet and capsule forms. However, each form should not be used in place of the other. Take only the form of this medicine your doctor has prescribed. If your doctor changes your brand, strength, or type of cabozantinib, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of cabozantinib you receive at the pharmacy.

Take cabozantinib on an empty stomach, at least 1 hour before or 2 hours after you eat anything.

Take this medicine with a full glass of water.

Do not open a cabozantinib capsule. Swallow it whole.

Your blood pressure will need to be checked often.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using cabozantinib. You may need to stop using the medicine for a short time.

If you have stopped taking cabozantinib for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking cabozantinib?

Grapefruit and grapefruit juice may interact with cabozantinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking cabozantinib.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of cabozantinib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking cabozantinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Stop using cabozantinib and call your doctor at once if you have:

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • heavy menstrual bleeding, or any other bleeding that will not stop;
  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • confusion, change in mental status, seizure (convulsions);
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain spreading to the arm or shoulder, sudden cough, wheezing, sweating, rapid breathing;
  • a light-headed feeling, like you might pass out;
  • puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy;
  • dangerously high blood pressure (buzzing in your ears, anxiety, shortness of breath, uneven heartbeats); or
  • jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work.

Once you have had any of the side effects listed above, you may never be able to use cabozantinib again. If you stop taking cabozantinib for any reason, talk to your doctor before you start taking the medication again.

Also call your doctor at once if you have any of these other side effects:

  • severe or ongoing vomiting or diarrhea;
  • weight loss, or a wound that will not heal;
  • pain, tenderness, redness, swelling, blistering, or peeling skin on the palms of your hands or the soles of your feet;
  • severe mouth pain that interferes with eating or drinking;
  • fever, flu symptoms, easy bruising;
  • dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • numbness or tingly feeling around your mouth, muscle tightness or contraction, overactive reflexes.

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea, constipation;
  • increased blood pressure;
  • abnormal liver function tests or other blood tests;
  • mouth sores or redness, changes in your sense of taste;
  • feeling tired, decrease in appetite or weight; or
  • changes in your hair color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cabozantinib?

Many drugs can interact with cabozantinib. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • St. John's wort;
  • an antibiotic --clarithromycin, telithromycin;
  • antifungal medicine --itraconazole, ketoconazole, posaconazole, voriconazole;
  • heart or blood pressure medicine --nicardipine, quinidine;
  • antiviral medicine to treat hepatitis or HIV/AIDS --atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir;
  • seizure medicine --carbamazepine, phenytoin; or
  • tuberculosis medicine --isoniazid, rifampin.

This list is not complete and many other drugs can interact with cabozantinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about cabozantinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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