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Regorafenib (By mouth)

Regorafenib (re-goe-RAF-e-nib)

Treats colon or rectal cancer and gastrointestinal stromal tumors (GIST) that have spread to other parts of the body. This medicine is a kinase inhibitor.

Brand Name(s):

Stivarga

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to regorafenib, or if you are pregnant.

How to Use This Medicine:

Tablet

  • Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
  • Take your medicine as directed.
  • Swallow the tablet whole. Do not crush, break, or chew it.
  • Take the tablet at the same time each day with a low-fat breakfast.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the tablets at room temperature, in the original container. Do not place the tablets in daily or weekly pill boxes. Keep the medicine away from heat, moisture, and direct light.
  • Ask your pharmacist about the best way to dispose of any leftover medicine after you have finished your treatment. Throw away any unused medicine 28 days after you first open the bottle.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are also using St John's wort, medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, posaconazole, rifampin, telithromycin, voriconazole, Nizoral®, Rifadin®, Rimactane®, Vfend®), or a blood thinner (such as warfarin, Coumadin®, Jantoven®).
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

  • Your unborn baby could be harmed if you use this medicine while you are pregnant. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Both men and women should use an effective form of birth control during therapy and for 2 months after the last dose. Tell your doctor right away if a pregnancy occurs within this time.
  • Make sure your doctor knows if you are breastfeeding, or if you have liver disease, bleeding problems, heart disease, or high blood pressure.
  • This medicine may cause serious liver problems. Your doctor will need to test your liver regularly while you are using this medicine.
  • This medicine may increase your risk of bleeding and slow healing of open wounds. Avoid rough sports or situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when you use sharp objects, including razors and fingernail clippers. Tell your doctor if you have a wound that will not heal.
  • This medicine may cause serious heart problems. Tell your doctor right away if you have chest pain, nausea, pain or discomfort in your arms, jaw, back, or neck, trouble breathing, unusual sweating, or vomiting.
  • Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
  • Tell your doctor right away if you have sudden severe stomach pain, swelling in your abdomen, or a high fever. These could be symptoms of a serious stomach problem.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Your blood pressure needs to be monitored on a regular basis.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating, faintness
  • Coughing up or vomiting blood or material that looks like coffee grounds
  • Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
  • Pain, redness, blistering, or swelling on the palms of your hands or the soles of your feet
  • Red or brown urine, red or black, tarry stools
  • Severe headache, seizure, confusion, vision problems
  • Severe rash
  • Sudden severe stomach pain or swelling, fever
  • Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

  • Hair loss
  • Hoarseness, voice changes
  • Loss of appetite, weight loss
  • Mild diarrhea
  • Swelling, pain, and redness in your mouth or throat
  • Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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


Last Updated: 10/4/2014


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