frequently asked questions
about COMETRIQ® (cabozantinib)

COMETRIQ® (Kō-mĕ-trik) 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.

  • How does COMETRIQ® work to treat MTC?

    COMETRIQ® may work in 3 important ways

    How does COMETRIQ® work?

    With this triple action, COMETRIQ® may temporarily stop the growth of, and even shrink, MTC tumors.

    COMETRIQ® treatment does not only target cancer cells.

    • Other parts of your body will also be affected by your treatment with COMETRIQ®, which could result in side effects

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

  • What are the benefits of taking COMETRIQ®?

    In a clinical study, COMETRIQ® was shown to help people with MTC that had spread to other parts of the body.

    COMETRIQ® helped to:

    • Delay the growth of MTC tumors in some people
    • Shrink MTC tumors in some people

    COMETRIQ® does not work for everyone. COMETRIQ® was not shown to help people with metastatic MTC live longer. Studies of COMETRIQ® are ongoing.

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

  • What are the risks of taking COMETRIQ®?

    To learn more, please click here to see Important Safety Information for COMETRIQ®, including Boxed Warnings, and click here to see the full Prescribing Information.

Taking COMETRIQ®

  • How do I take COMETRIQ®?

    COMETRIQ® comes in 80 mg and 20 mg capsules that are swallowed. Your healthcare provider will tell you how many of each capsule to take.

    Do not eat food for at least 2 hours before or 1 hour after taking COMETRIQ®

    Remember to:

    • Take COMETRIQ® on an empty stomach. You should not eat anything 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, open, or chew COMETRIQ® capsules. Take all capsules that make up your dose, swallowing each capsule individually
    • Take COMETRIQ® exactly as your healthcare provider tells you to take it

    Do NOT substitute COMETRIQ® capsules with cabozantinib tablets.

    Call your healthcare provider if you have any problems or experience side effects.

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

  • What can I do to help me remember to take my dose every day?

    Take COMETRIQ® at the same time every day. You'll need to figure out what works best for you and fits in with your daily schedule.

    Suggestions for scheduling COMETRIQ® around meals

    If you take COMETRIQ® at bedtime

    Do not eat for at least 2 hours before bedtime, then take your dose just before bedtime

    If you take COMETRIQ® when you wake up

    Take your dose as soon as you get up in the morning, then wait for at least 1 hour before having breakfast

    If you take COMETRIQ® during the day

    After a meal, wait for at least 2 hours before taking your dose and make sure you don't eat again for at least 1 hour

    Do NOT substitute COMETRIQ® capsules with cabozantinib tablets.

    Remember to also think about days when your routine is different, such as weekends or days off. Try to be as consistent as possible.

    Set up reminders on your phone or computer, or have someone remind you

    Bring your medicine with you when you travel

    Call your healthcare provider immediately if you take too much COMETRIQ®.

    Learn what to do if you miss your scheduled dose

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

  • Is there anything I should avoid while taking COMETRIQ®?

    Use caution while driving or using machinery. Keep in mind that COMETRIQ® may make you feel tired or weak

    You should NOT drink or eat anything that contains grapefruit or grapefruit juice

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

  • I forgot to take my dose—what should I do?

    ONLY take your missed dose if it is within 12 HOURS of when you would have normally taken it. Then take your next dose at the normal time.

    Your next dose is in
    LESS than 12 hours
    DO NOT TAKE
    the missed dose
    Your next dose is in
    12 hours OR MORE
    TAKE the missed
    dose as soon as
    you remember

    Do NOT substitute COMETRIQ® capsules with cabozantinib tablets.

    Call your healthcare provider if you have questions about a missed dose.

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

  • What should I do if I take too much COMETRIQ®?

    Call your healthcare provider right away if you have taken too much COMETRIQ®.

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

  • How do I dispose of unused or expired COMETRIQ®?

    Exelixis' COMETRIQ® Mail-Back Program

    Starting in 2012, various local county boards of supervisors in the United States passed ordinances requiring pharmaceutical producers that sell, offer for sale, or distribute certain prescription drugs to patients residing in their respective counties to implement a process for the safe collection and disposal of any unwanted pharmaceutical products supplied to patients residing in those counties.

    If you are in possession of COMETRIQ® that is either expired or will not be used, please follow these steps to have your expired, unwanted, or unused COMETRIQ® safely collected and disposed of at no cost to you, the patient:

    1. Call our specialty pharmacy, Diplomat, at the following toll-free number:
    2. Inform the representative that you would like to return your unused or expired COMETRIQ®
    3. Look for a prepaid self-addressed package that will be sent to you by the representative
    4. Simply place the unused or expired COMETRIQ® in its original packaging inside the prepaid self-addressed package, seal the package, and drop it off at the nearest mail carrier’s site

    Call 1-855-253-EASE (1-855-253-3273) for safe disposal.

    Additional information for patients residing within Alameda County, California

    For any patients receiving COMETRIQ® within Alameda County, California, there are also fixed locations currently operating within Alameda County where residents can drop off their unwanted prescription drugs. If you wish to learn more about the Alameda ordinance, including locations within Alameda County where you can drop off your unwanted prescription drugs, please visit the Alameda County Environmental Health Safe Drug Disposal Web page:

    www.acgov.org/aceh/safedisposal/index.htm

Managing side effects

  • What should I do if I begin to have side effects?

    Talk to your healthcare provider if you experience any side effects during treatment. Your healthcare provider may be able to help.

    Read more about the most common side effects of COMETRIQ®. You can also click here for additional Important Safety Information for COMETRIQ®, including Boxed Warnings, and click here to see the full Prescribing Information.

Dose reductions and interruptions

  • Will my healthcare provider reduce or stop my dose because of side effects?

    Talk to your healthcare provider if you are experiencing side effects. Your healthcare provider may reduce or stop your dose to help manage them.

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

Getting support

  • What if I need help paying for COMETRIQ®?

    Exelixis® Access Services (EASE) is a personalized support program that provides information about how to afford COMETRIQ® treatment if you qualify. Just call the helpline to ask questions you may have about paying for your COMETRIQ® treatment.

    You can contact EASE by calling 1-855-253-EASE (1-855-253-3273).

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

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:

  • 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 get:
    • severe pain in your stomach-area (abdomen)
    • coughing, gagging, and choking especially when eating or drinking
  • Severe bleeding (hemorrhage). Tell your healthcare provider right away if you get 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

What are the possible side effects of COMETRIQ?

COMETRIQ may cause other serious side effects, including:

  • See "What is the most important information I should know about COMETRIQ?"
  • 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
    • 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). Hypertension is common with COMETRIQ and can be severe. Your healthcare provider will check your blood pressure before starting COMETRIQ and during treatment with COMETRIQ. If needed, your healthcare provider may prescribe medicine to treat your 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. 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 called reversible posterior leukoencephalopathy syndrome can happen during treatment with COMETRIQ. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.

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 are:

  • 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
  • increased liver function blood tests
  • decreased calcium and phosphate blood levels
  • decreased white blood cell counts
  • decreased platelet counts
  • increased bilirubin blood levels

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.

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 wound
  • have high blood pressure
  • plan to have any surgery or a dental procedure
  • have liver problems
  • are pregnant or plan to become pregnant. COMETRIQ can harm your unborn baby. If you are able to become pregnant, you should use effective birth control 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 or over-the-counter medicines, vitamins, and herbal supplements. COMETRIQ and certain other medicines may affect each other causing side effects.

How should I take COMETRIQ?

  • Take COMETRIQ exactly as your healthcare provider tells you to take it.
  • Do not take COMETRIQ with food. Do not eat for at least 2 hours before and at least 1 hour after taking COMETRIQ.
  • Swallow COMETRIQ capsules whole with a full glass (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.

What should I avoid while taking COMETRIQ?

Do not drink grapefruit juice, eat grapefruit or supplements that contain grapefruit 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.

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

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