COMETRIQ® (Ko-me-trik) cabozantinib capsules

INDICATION AND IMPORTANT SAFETY INFORMATION

What are the possible side effects of COMETRIQ?

COMETRIQ may cause serious side effects, including:

  • A tear in your stomach or intestinal wall (perforation), or an abnormal connection between 2 parts of your body (fistula) that may lead to death. Tell your healthcare provider right away if you get tenderness or pain in your stomach area (abdomen) that is severe or that does not go away.
  • Bleeding (hemorrhage). COMETRIQ can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with COMETRIQ, including:
    • coughing up blood or blood clots
    • vomiting blood or if your vomit looks like coffee grounds
    • red or black (looks like tar) stools
    • menstrual bleeding that is heavier than normal
    • any unusual or heavy bleeding
  • Blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you get:
    • swelling or pain in your arms or legs
    • shortness of breath
    • light-headed or faint
    • sweating more than usual
    • numbness or weakness of your face, arm, or leg, especially on one side of your body
    • sudden confusion, trouble speaking or understanding
    • sudden trouble seeing in one or both eyes
    • sudden trouble walking
    • dizziness, loss of balance or coordination
    • a sudden severe headache
  • Wound healing problems. Wound healing problems have happened in some people who take COMETRIQ. Tell your healthcare provider if you plan to have any surgery before or during treatment with COMETRIQ.
    • You should stop taking COMETRIQ at least 3 weeks before planned surgery.
    • Your healthcare provider should tell you when you may start taking COMETRIQ again after surgery.
  • High blood pressure (hypertension). Hypertension is common with COMETRIQ and can be severe. Your healthcare provider will check your blood pressure before you start and regularly during treatment with COMETRIQ. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. Tell your healthcare provider if you develop severe headaches, nose bleeds, tiredness or confusion, vision changes, chest pain, trouble breathing, irregular heartbeat, or blood in your urine.
  • Severe jaw bone problems (osteonecrosis). Your healthcare provider should examine your mouth before you start and during treatment with COMETRIQ. Tell your dentist that you are taking COMETRIQ. It is important for you to practice good mouth care during treatment with COMETRIQ. Tell your healthcare provider right away if you develop any symptoms of jaw problems including: jaw pain, toothache, or sores on your gums.
  • Diarrhea. Diarrhea is common with COMETRIQ and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements.
  • A skin problem called hand-foot skin reaction. Hand-foot skin reactions are common with COMETRIQ and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
  • Protein in your urine and possible kidney problems. Symptoms may include swelling in your hands, arms, legs, or feet.
  • Reversible posterior leukoencephalopathy syndrome (RPLS). A condition that affects circulation in the brain called RPLS can happen during treatment with COMETRIQ. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.
  • Decreased calcium level in your blood (hypocalcemia). COMETRIQ can cause you to have a decreased amount of calcium in your blood. Your healthcare provider will do blood tests to check you for this problem and give you calcium if needed. Tell your healthcare provider right away if you get any of the following signs or symptoms:
    • muscle stiffness or muscle spasms
    • numbness or tingling in your fingers, toes, or around your mouth
    • seizures
    • sudden weight gain
    • swelling of your arms, hands, legs, and ankles

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with COMETRIQ if you have certain side effects.

The most common side effects of COMETRIQ include:

  • diarrhea
  • redness, swelling or pain in your mouth or throat, or mouth sores. Tell your healthcare provider if these symptoms prevent you from eating or drinking
  • weight loss
  • decreased appetite
  • nausea
  • tiredness
  • hair color turning lighter
  • change in taste
  • pain in your abdomen
  • constipation

The most common abnormal blood test results with COMETRIQ include:

  • increased liver function blood tests
  • decreased white blood cell counts
  • increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems)
  • decreased calcium and phosphate blood levels
  • decreased platelet counts
  • increased bilirubin blood levels

COMETRIQ may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of COMETRIQ.

Before you take COMETRIQ, tell your healthcare provider about all of your medical conditions, including if you:

  • have a recent history of coughing up blood or bleeding, or any unusual bleeding
  • have an open or healing wound
  • have high blood pressure
  • have a low calcium level in your blood (hypocalcemia)
  • plan to have any surgery, a dental procedure, or have had a recent surgery. You should stop taking COMETRIQ at least 3 weeks before planned surgery. See “What are the possible side effects of COMETRIQ?”
  • have liver problems
  • are pregnant or plan to become pregnant. COMETRIQ can harm your unborn baby.
    • If you are able to become pregnant, your healthcare provider will check your pregnancy status before you start treatment with COMETRIQ.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after the final dose of COMETRIQ.
    • Talk to your healthcare provider about birth control methods that may be right for you.
    • If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • are breastfeeding or plan to breastfeed. It is not known if COMETRIQ passes into your breast milk. Do not breastfeed during treatment and for 4 months after the final dose of COMETRIQ.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. COMETRIQ and certain other medicines may affect each other, causing side effects.

What should I avoid while taking COMETRIQ?

Do not drink grapefruit juice, eat grapefruit or take supplements that contain grapefruit or St. John’s wort during treatment with COMETRIQ.

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

What is COMETRIQ?

COMETRIQ is a prescription medicine used to treat people with medullary thyroid cancer that has spread to other parts of the body.

It is not known if COMETRIQ is safe and effective in children.

Please see the Patient Information in the accompanying full Prescribing Information.

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