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).
- 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 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.
- 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 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, 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, 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.
What should I avoid while taking COMETRIQ?
Do not drink grapefruit juice, eat grapefruit, or take 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.
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 accompanying full Prescribing Information for COMETRIQ.
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