Generic Name: cabozantinib (KA-boe-ZAN-ti-nib)
Brand Name: Cometriq
Serious stomach or bowel problems (eg, fistula, perforation) may occur with Cometriq. These effects are not common, but may be serious and sometimes fatal. Tell your doctor right away if you develop severe or unusual stomach pain, or coughing, gagging, or choking, especially when eating or drinking.
The risk of severe and sometimes fatal bleeding problems is increased with Cometriq. Patients who have severe bleeding should not use Cometriq. Contact your doctor right away if you experience severe or unusual bruising or bleeding, including coughing up blood or blood clots; black, tarry, or bloody stools; blood in the vomit or vomit that looks like coffee grounds; or unusually heavy menstrual bleeding.
Cometriq is used for:
Treating a certain type of thyroid cancer that has spread to other parts of the body. It may also be used for other conditions as determined by your doctor.
Cometriq is a kinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use Cometriq if:
- you are allergic to any ingredient in Cometriq
- you have severe bleeding or have a recent history of bleeding or coughing up blood
- you have moderate or severe liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Cometriq:
Some medical conditions may interact with Cometriq. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have high blood pressure, liver problems, kidney problems, or protein in your urine
- if you have a history of coughing up blood or bleeding
- if you have an open wound
- if you have had recent surgery or plan to have surgery or a dental procedure
Some MEDICINES MAY INTERACT with Cometriq. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Atazanavir, boceprevir, clarithromycin, cobicistat, fosamprenavir, indinavir, itraconazole, ketoconazole, mifepristone, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole because they may increase the risk of Cometriq's side effects
- Carbamazepine, dexamethasone, enzalutamide, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Cometriq's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Cometriq may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Cometriq:
Use Cometriq as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Cometriq. Talk to your pharmacist if you have questions about this information.
- Take Cometriq by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
- Swallow Cometriq whole with at least 8 oz (240 mL) of water. Do not break, crush, or open before swallowing.
- Do not eat grapefruit, drink grapefruit juice, or take any foods or supplements that contain grapefruit while you use Cometriq.
- Take Cometriq on a regular schedule to get the most benefit from it.
- Continue to take Cometriq even if you feel well. Do not miss any doses.
- If you miss a dose of Cometriq, take it as soon as possible. If there are less than 12 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Cometriq.
Important safety information:
- Cometriq may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Cometriq with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT change your dose or stop taking Cometriq without checking with your doctor.
- Cometriq may cause jawbone problems in some patients. Tell your doctor right away if you experience jaw pain, a toothache, or sores on your gums. Talk to your doctor about having a dental exam before you start to take Cometriq and during treatment.
- Proper dental care is important while you are taking Cometriq. Brush and floss your teeth and visit the dentist regularly.
- Tell your doctor or dentist that you take Cometriq before you receive any medical or dental care, emergency care, or surgery. You may need to stop Cometriq at least 28 days before planned surgery (including dental procedures) as directed by your doctor. Your doctor will decide when you should start to take it again.
- A serious and sometimes fatal brain problem called reversible posterior leukoencephalopathy syndrome (RPLS) has been reported in patients taking Cometriq. Contact your doctor right away if you experience severe headaches, seizures, sluggishness, confusion, problems thinking, or vision changes (eg, loss of vision).
- Cometriq may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Cometriq may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Cometriq may cause mouth sores or pain, changes in taste, nausea, or vomiting. Tell your doctor if any of these symptoms are severe or prevent you from eating or drinking.
- Women who may become pregnant must use an effective form of birth control while taking Cometriq and for at least 4 months after the last dose. If you have questions about effective birth control, talk with your doctor.
- Men who may father a child must use effective birth control while taking Cometriq and for at least 4 months after the last dose. If you have questions about effective birth control, talk with your doctor. If your partner becomes pregnant, contact your doctor right away.
- Lab tests, including urine protein levels, liver function, blood pressure, and complete blood cell counts, may be performed while you use Cometriq. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Cometriq should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Cometriq may cause harm to the fetus. Do not become pregnant while you are taking it and for at least 4 months after you stop taking it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Cometriq while you are pregnant. It is not known if Cometriq is found in breast milk. Do not breast-feed while taking Cometriq.
Possible side effects of Cometriq:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Change in taste; constipation; decreased appetite; diarrhea; dizziness; dry skin; hair color changes; hair loss; headache; joint pain; mild stomach pain or upset; mouth sores; nausea; redness, swelling, or pain in your mouth or throat; tiredness; voice changes or hoarseness; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; calf or leg pain, swelling, redness, or tenderness; change in the amount of urine produced; chest, jaw, or arm pain; confusion; coughing, gagging, or choking, especially when eating or drinking; fainting; fever, chills, or persistent sore throat; light-headedness; loss of balance or coordination; numbness or weakness of your face, arm, or leg, especially on one side of your body; redness, pain, swelling, or blisters on the palms of your hands or soles of your feet; seizures; severe or persistent dizziness or headache; severe or persistent stomach pain, diarrhea, nausea, or vomiting; severe or unusual bruising or bleeding (eg, coughing up blood or blood clots; black, tarry, or bloody stools; blood in the vomit or vomit that looks like coffee grounds; unusually heavy menstrual bleeding); shortness of breath; speech problems; swelling or pain of the hands, arms, legs, or feet; symptoms of low blood calcium levels (eg, muscle aches, cramps, or spasms; numbness or tingling of the lips, tongue, fingers, or toes); trouble swallowing; trouble walking; unusual sweating; unusual tiredness or weakness; unusual weight loss; vision changes; wounds that do not heal; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Cometriq:
Store Cometriq at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cometriq out of the reach of children and away from pets.
- If you have any questions about Cometriq, please talk with your doctor, pharmacist, or other health care provider.
- Cometriq is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Cometriq or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Cometriq. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cometriq. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Cometriq.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.