cometriq

Cometriq (cabozantinib) interferes with the growth of some cancer cells.

Cometriq is used to treat thyroid cancer that has spread to other parts of the body.

Cometriq may also be used for purposes not listed in this medication guide.

Important information

Cometriq can increase your risk of serious bleeding. Stop using Cometriq and call your doctor at once if you have severe stomach pain, bloody or tarry stools, coughing up blood, or any heavy or unusual bleeding.

Some people taking Cometriq have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Before taking this medicine

You should not use Cometriq if you are allergic to cabozantinib.

To make sure Cometriq is safe for you, tell your doctor if you have:

• high blood pressure;

• liver disease;

• an open wound or sore on your skin;

• a bleeding or blood-clotting disorder;

• a pre-existing dental problem;

• if you have recently had surgery or dental work; or

• if you have recently had any unusual or heavy bleeding.

FDA pregnancy category D. Cabozantinib can harm an unborn baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

• If you are a woman, do not take cabozantinib if you are pregnant.

• If you are a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is taking cabozantinib.

• Use birth control to prevent pregnancy while you are receiving Cometriq, whether you are a man or a woman. Keep using birth control for at least 4 months after treatment ends.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking Cometriq.

It is not known whether cabozantinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Cometriq.

How should I take Cometriq?

Cometriq is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Cometriq on an empty stomach, at least 1 hour before or 2 hours after you eat anything.

Take this medicine with a full glass of water.

Do not open a Cometriq capsule. Swallow it whole.

Your blood pressure will need to be checked often.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using Cometriq. You may need to stop using the medicine for a short time.

If you have stopped taking Cometriq for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose.

Store Cometriq at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Grapefruit and grapefruit juice may interact with Cometriq and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Cabozantinib can pass into body fluids (including urine, feces, vomit). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Cometriq side effects

Get emergency medical help if you have any signs of an allergic reaction to Cometriq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking Cometriq have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Stop using Cometriq and call your doctor at once if you have:

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• heavy menstrual bleeding, or any other bleeding that will not stop;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• change in mental status, seizure (convulsions);

• pain, swelling, warmth, or redness in one or both legs;

• chest pain spreading to the arm or shoulder, sudden cough, wheezing, sweating, rapid breathing;

• a light-headed feeling, like you might pass out;

• puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy;

• dangerously high blood pressure (buzzing in your ears, anxiety, shortness of breath, uneven heartbeats); or

• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work.

Once you have had any of the side effects listed above, you may never be able to use Cometriq again. If you stop taking this medicine for any reason, talk to your doctor before you start taking it again.

Also call your doctor at once if you have any of these other side effects while using Cometriq:

• severe or ongoing vomiting or diarrhea;

• a wound that will not heal;

• pain, tenderness, redness, swelling, blistering, or peeling skin on the palms of your hands or the soles of your feet;

• severe mouth pain that interferes with eating or drinking;

• fever, flu symptoms, easy bruising;

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• numbness or tingly feeling around your mouth, muscle tightness or contraction, overactive reflexes.

Common side effects may include:

• nausea, diarrhea, constipation;

• mild mouth discomfort, changes in your sense of taste;

• feeling weak or tired, decrease in appetite or weight; or

• hoarseness in your voice, changes in your hair color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Cometriq?

Many drugs can interact with Cometriq. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Cometriq, especially:

• bosentan;

• conivaptan;

• dexamethasone;

• imatinib;

• nefazodone;

• St. John"s wort;

• an antibiotic--clarithromycin, nafcillin, rifabutin, rifampin, rifapentine, telithromycin;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• heart medication--nicardipine, quinidine;

• hepatitis C medications--boceprevir, telaprevir;

• HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir; or

• seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone.

This list is not complete and many other drugs can interact with Cometriq. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.