IMPORTANT SAFETY INFORMATION

What is the most important information I should know about COMETRIQ®?

COMETRIQ can cause serious side effects which can lead to death, including:

Severe bleeding (hemorrhage). Tell your healthcare provider right away if you have any signs of bleeding while taking or after you stop taking 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

A tear in your stomach or intestinal wall (perforation), or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you have:

  • severe pain in your stomach area (abdomen)
  • coughing, gagging, and choking especially when eating or drinking

COMETRIQ may cause other serious side effects, including:

  • See “What is the most important information I should know about COMETRIQ?” above
  • Blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you have:
    • swelling or pain in your arms or legs
    • shortness of breath
    • feel lightheaded 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. If you need to have surgery, tell your healthcare provider that you are taking COMETRIQ. Your healthcare provider should stop your treatment with COMETRIQ at least 28 days before any planned surgery, including dental procedures. Your healthcare provider should tell you when you may start taking COMETRIQ again after surgery
  • High blood pressure (hypertension), which may be severe. Your healthcare provider should check your blood pressure during treatment with COMETRIQ. If needed, your healthcare provider should prescribe medicine for you to treat high blood pressure
  • Severe jaw bone problems (osteonecrosis). Symptoms may include jaw pain, toothache, or sores on your gums. 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
  • A skin problem called hand-foot skin reaction. Symptoms may include 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). This condition can happen while taking COMETRIQ. Call your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking

Your healthcare provider may tell you to stop taking COMETRIQ if you have any of the serious side effects listed above.

The most common side effects of COMETRIQ are redness, swelling, or pain in your mouth or throat, or mouth sores; diarrhea; weight loss; decreased appetite; nausea and vomiting; tiredness and weakness; change in taste; hair color turning lighter; constipation; voice changes or hoarseness; change in liver function blood tests; low levels of calcium in your blood.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of COMETRIQ. For more information, ask your healthcare provider or pharmacist. Keep COMETRIQ and all medications out of the reach of children.

Before you take COMETRIQ, tell your healthcare provider if you:

  • have high blood pressure
  • have a recent history of coughing up blood or bleeding or any unusual bleeding
  • have an open wound
  • have had recent surgery or plan to have surgery or a dental procedure
  • have liver problems
  • have any other medical conditions
  • are pregnant or you or your partner plans to become pregnant. COMETRIQ can cause harm to your unborn baby. Talk to your healthcare provider if you are pregnant or if you or your partner plans to become pregnant
  • are a female who is able to become pregnant or are a male whose female partner is able to become pregnant. You should use effective birth control during your treatment with COMETRIQ and for at least 4 months after your last dose of COMETRIQ
    • Talk to your healthcare provider about birth control methods to prevent pregnancy while you are taking COMETRIQ
    • Tell your healthcare provider right away if you or your female partner becomes pregnant while taking COMETRIQ
  • are breastfeeding or plan to breastfeed. It is not known if COMETRIQ passes into your breast milk. You and your healthcare provider should decide if you will take COMETRIQ or breastfeed. You should not do both

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

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take COMETRIQ?

  • Take COMETRIQ exactly as your healthcare provider tells you to take it
  • Take COMETRIQ on an empty stomach, do not eat for at least 2 hours before and at least 1 hour after taking COMETRIQ
  • Swallow COMETRIQ capsules whole with at least 8 ounces of water. Do not crush or open COMETRIQ capsules
  • If you miss a dose and your next dose is in:
    • less than 12 hours, take your next dose at the normal time. Do not make up the missed dose
    • 12 hours or more, take the missed dose as soon as you remember. Take your next dose at the normal time
  • Call your healthcare provider right away if you take too much COMETRIQ

What should I avoid while taking COMETRIQ?

You should not drink grapefruit juice or eat grapefruit or any foods or supplements that contain these products during treatment with COMETRIQ. They may increase the amount of COMETRIQ in your blood.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Please click here to see the full Prescribing Information for COMETRIQ®, including Boxed Warnings.

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