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Cometriq Warnings and Precautions

By discussing your medical history and current medications with your healthcare provider before taking Cometriq, you can help minimize potentially dangerous complications. Safety precautions with Cometriq include warnings of potential drug interactions, allergic reactions, and a serious brain condition. Also, people who have an open wound or a history of blood clots may not be able to use this medicine.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Cometriq™ (cabozantinib) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure
  • Recently had abnormal or excessive bleeding problems
  • Recently coughed up blood
  • An open wound
  • Had a recent heart attack
  • Had a blood clot
  • An upcoming surgery, including dental surgeries
  • High blood pressure (hypertension)
  • Any allergies, including to foods, dyes, or preservatives.
In addition, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings for Cometriq

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Cometriq can cause excessive bleeding (known medically as hemorrhage), which can be life-threatening. Let your healthcare provider know immediately if you have any signs of bleeding, such as:
    • Any unusual or unexplained bleeding
    • Red, black, or tarry stools
    • Coughing up blood
    • Vomiting blood or vomit that looks like coffee grounds
    • Very heavy menstrual bleeding in women.
  • This medicine may increase the risk for a tear (a perforation) in your stomach, intestines, or fistula. A fistula is an abnormal connection between two body parts that do not normally connect, such as between the trachea (the windpipe) and the esophagus (the tube that leads from the mouth to the stomach). Let your healthcare provider know immediately if you have severe abdominal (stomach) pain or coughing or choking when you try to swallow, as these may be signs of these serious side effects.
  • Although rare, there have been reports of people developing a severe jaw bone problem known as osteonecrosis of the jaw during Cometriq treatment. Osteonecrosis of the jaw occurs when the jaw bone becomes exposed and begins to die. Make sure you practice good oral hygiene while taking this drug, and visit your dentist regularly. Let your healthcare provider know if you develop any jaw or mouth pain.
  • Cometriq has been reported to cause a potentially serious brain condition known as reversible posterior leukoencephalopathy syndrome. Contact your healthcare provider right away if you develop symptoms of this condition, which may include:
  • Hand-foot syndrome is a side effect of some cancer medications, and can occur with Cometriq use. Hand-foot syndrome causes redness, pain, swelling, blisters, and possibly flaking on the palms of the hands and soles of the feet. If you develop hand-foot syndrome, you should talk to your healthcare provider about ways to manage it and prevent it from becoming worse. If the condition is severe, you may need to stop taking this drug, at least until your symptoms improve.
  • Cometriq can increase your risk for developing blood clots, including potentially dangerous clots in the arms or legs, a heart attack, or a stroke (see Signs of a Stroke or Heart Attack Symptoms). Let your healthcare provider know if you develop any signs of these problems, such as:
    • Chest pain
    • Pain or swelling in an arm or leg
    • Signs of a heart attack or stroke.
  • Many people who take this medication will develop high blood pressure (hypertension). Your healthcare provider will monitor your blood pressure throughout treatment. If your blood pressure increases too much, you may need to take medication to control it or stop taking it altogether.
  • Cometriq may cause kidney problems or a condition known as proteinuria. Proteinuria is when the urine contains an abnormal amount of protein. It can occur in people whose kidneys are not working as well as they should. Your healthcare provider will periodically monitor the amount of protein in your urine during treatment. Let your healthcare provider know if you have swelling in the arms, hands, legs, ankles, or feet, as this could be a sign of kidney problems.
  • This medicine can cause wounds to heal more slowly. As a result, you will need to stop taking it at least 28 days before having a planned surgery, including dental surgery. Your healthcare provider will let you know when you can start taking it again. You should also let your healthcare provider know if you have any wounds or sores that are not healing or are healing slowly.
  • People with moderate or severe liver disease should generally not use Cometriq.
  • Cometriq is a pregnancy Category D medication, which means it may harm an unborn child. Talk to your healthcare provider about the risks and benefits of using this medication when pregnant (see Cometriq and Pregnancy).
  • It is unknown if Cometriq passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Cometriq and Breastfeeding).
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