Cometriq

Cometriq is a prescription medication used to treat a certain type of thyroid cancer that has spread to other parts of the body. Cometriq belongs to a group of drugs called tyrosine kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Cometriq comes as a capsule to take by mouth. It is usually taken once a day on an empty stomach. Patients should not eat for at least 2 hours before and at least 1 hour after taking Cometriq.

Common side effects diarrhea, inflammation and sores in the mouth, decreased weight, and decreased appetite.

Cometriq is a prescription medication used to treat a certain type of thyroid cancer that has spread to other parts of the body.

It is not known if Cometriq is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Exelixis, Inc.

Common side effects include the following:

• redness, swelling or pain in your mouth or throat, or mouth sores
• diarrhea
• weight loss
• decreased appetite
• nausea and vomiting
• tiredness and weakness
• change in taste
• hair color turning lighter
• constipation
• voice changes or hoarseness
• change in liver function blood tests
• low levels of calcium in your blood

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, nimodipine (Nimotop), rifabutin, rifapentine, and dexamethasone
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (atazanavir, indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone

This is not a complete list of Cometriq drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cometriq including the following:

• 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
• 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
• 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) which may be severe. Your healthcare provider should check your blood pressure during treatment with Cometriq. If needed, your healthcare provider should prescribe medicine for you to treat 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. Symptoms may include: 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 while taking Cometriq. Call your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.

Do not take this medication if you are allergic to Cometriq or to any of its ingredients.

Grapefruit and grapefruit juice may interact with this medication and can lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you take Cometriq, tell your healthcare provider if you:

• have high blood pressure
• have a recent history of coughing up blood or bleeding or any unusual bleeding
• have an open wound
• have had recent surgery or plan to have surgery or a dental procedure
• have liver problems
• have any other medical conditions
• are pregnant or you or your partner plan to become pregnant. Cometriq can cause harm to your unborn baby. Talk to your healthcare provider if you are pregnant or if you or your partner plan to become pregnant.
• are a female who is able to become pregnant, or are a male whose female partner is able to become pregnant; you should use effective birth control during your treatment with Cometriq and for at least 4 months after your last dose of Cometriq.
• are breastfeeding or plan to breastfeed. It is not known if Cometriq passes into your breast milk. You and your healthcare provider should decide if you will take Cometriq or breastfeed. You should not do both.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Based on how this medication works, it is expected to cause harm to a fetus (unborn baby) is exposed to Cometriq. Talk to your healthcare provider about birth control methods to prevent pregnancy while you are taking Cometriq. Tell your healthcare provider right away if you or your female partner becomes pregnant while taking Cometriq.

Breastfeeding mothers must discontinue nursing while receiving Cometriq therapy.

• Take Cometriq exactly as your healthcare provider tells you to take it.
• Take Cometriq on an empty stomach, do not eat 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 or open Cometriq capsules.
• If you miss a dose and your next dose is in:
       ο  less than 12 hours, take your next dose at the normal time. Do not make up the missed dose.
       ο  12 hours or more, take the missed dose as soon as you remember. Take your next dose at the normal time.
• Call your healthcare provider right away if you take too much Cometriq.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 140 mg by mouth once daily.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this medication in the container it came in, tightly closed, and out of reach of children.
• Store it at room temperature and away from excess heat and moisture (not in the bathroom).

• Perforations and Fistulas: Gastrointestinal perforations occurred in 3% and fistula formation in 1% of Cometriq-treated patients. Discontinue Cometriq in patients with perforation or fistula.
• Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and gastrointestinal hemorrhage occurred in 3% of Cometriq-treated patients. Monitor patients for signs and symptoms of bleeding. Do not administer Cometriq to patients with severe hemorrhage.