There are benefits and risks with taking COMETRIQ® (cabozantinib) and it's important to know what they are. Talk to your healthcare provider if you experience any side effects during treatment. If you experience side effects while taking COMETRIQ®, your healthcare provider may be able to help.
Some side effects can be managed so that you may be able to stay on therapy.
- Some medicines (prescription or over-the-counter) can help treat side effects
- You may be told to stop taking COMETRIQ® for a short time
- You may be given a lower dose of COMETRIQ®
- You may be told to permanently stop taking COMETRIQ® if you develop serious side effects
There are different kinds of side effects
Side effects that you can see or feel
- Certain side effects can change the way you feel (like being tired) or look (like a rash)
Side effects your healthcare provider finds using tests
- Certain side effects are found by your healthcare provider (like high blood pressure or changes in blood test results)
The most common side effects of COMETRIQ® are diarrhea; redness; swelling, or pain in your mouth or throat, or mouth sores; weight loss; decreased appetite; nausea; tiredness; hair color turning lighter; change in the way foods taste; pain in the abdomen; constipation; increased liver function blood tests; and decreased levels of calcium and phosphate in your blood, decreased white blood cell and platelet counts, and increased bilirubin blood levels.
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.
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:
- 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
- hair color turning lighter
- change in taste
- pain in your abdomen
- 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.
Back to top