Regorafenib (Generic Name)

Other Names: Stivarga®

About This Drug

Regorafenib is used to treat cancer. It is given by mouth (orally).

Possible Side Effects (More Common)

  • Infections
  • High blood pressure
  • Diarrhea
  • Hand-and-foot syndrome: The palms of your hands or soles of your feet may tingle, become numb, painful, swollen, or red.
  • Soreness of the mouth and throat: You may have red areas, white patches, or sores that are painful.
  • Fatigue
  • Weakness
  • Loss of appetite,
  • Weight loss
  • Voice changes or hoarseness

Possible Side Effects (Less Common)

  • Severe bleeding problems
  • Changes in liver function. Your liver function will be checked as needed.
  • Decreased blood flow to your heart. Symptoms of a heart attack: Most heart attacks involve discomfort in the center of the chest that lasts more than a few minutes, or the discomfort may go away and come back. It can feel like uncomfortable pressure, squeezing, fullness, or pain. Sometimes discomfort is felt in one or both arms, the back, neck, jaw, or stomach. If any of these symptoms last 2 minutes, call 911.
  • A tear in your stomach or intestinal wall
  • Wound healing problems
  • A brain syndrome that may cause headaches, confusion, seizures, and/or loss of vision.

Reproduction Concerns

  • Pregnancy warning: This drug may have harmful effects on the unborn child, so effective methods of birth control should be used during your cancer treatment.
  • Genetic counseling is available to you to discuss the effects of this drug therapy on future pregnancies. In addition, a genetic counselor can review the potential risks of problems in the fetus due to this medication if an exposure during pregnancy has occurred.
  • Breast-feeding warning: It is not known if this drug passes into breast milk. For this reason, women are advised to discuss with their doctor the risks and benefits of breast-feeding during treatment with this drug because this drug may enter the breast milk and seriously harm a breast-feeding infant.

Treating Side Effects

  • Drink 6 to 8 cups of fluids every day unless your doctor has told you to restrict your fluid intake due to another medical condition. A cup is 8 ounces of fluid. If you vomit or have diarrhea, you should drink more fluids so that you do not become dehydrated.
  • Mouth care is very important. Your mouth care should consist of regular, gentle cleaning of your teeth or dentures and rinsing your mouth with a mixture of 1/2 teaspoon of salt in 8 ounces of water or ½ teaspoon of sodium bicarbonate (baking soda) in 8 ounces of water. This should be done at least after every meal and at bedtime.
  • If you have mouth sores, avoid mouthwash that contains alcohol. Avoid alcohol and smoking because they can irritate your mouth and throat.
  • Do not put anything on sore palms of your hands or soles of your feet unless your doctor or nurse says you may. Ask your doctor for pain medication as needed.
  • Ask you doctor for medications to prevent or lessen diarrhea.

Important Information

  • Take regorafenib at the same time each day with a low-fat breakfast.
  • Keep regorafenib in the bottle that it comes in. Do not put tablets in a daily or weekly pill box. The bottle contains a desiccant to help keep your medicine dry. Keep the desiccant in the bottle.
  • Keep the bottle of regorafenib tightly closed and safely throw away any unused regorafenib tablets 28 days after opening the bottle.

Food and Drug Interactions

There are known interactions of regorafenib with food. Do not eat grapefruit or drink grapefruit juice. Do not take St. John’s Wort. This drug may interact with other medications. Tell your doctor and pharmacist about all the medication and dietary supplements (vitamins, minerals, herbs, and others) that you are currently taking. The safety and effectiveness of dietary supplements and alternative diets are often unknown. Using these might unexpectedly affect your cancer or interfere with your treatment. Until more is known, you should not use dietary supplements or alternative diets without your cancer doctor's advice.

When to Call the Doctor

Call your doctor or nurse immediately if you have any of the following symptoms:

  • Fever of 100.5 F (38 C) or above
  • Chills
  • Unusual bleeding or bruising
  • Blood in your stool. Black or tarry stool
  • Difficulty breathing
  • Chest pain or symptoms of a heart attack. Most heart attacks involve discomfort in the center of the chest that lasts more than a few minutes, or the discomfort may go away and come back. It can feel like uncomfortable pressure, squeezing, fullness, or pain. Sometimes discomfort is felt in one or both arms, the back, neck, jaw, or stomach. If any of these symptoms last 2 minutes, call 911.
  • Signs of liver problems: dark urine (tea colored), pale stools, severe stomach pain, severe tiredness or weakness, unusual itching, your skin or whites of your eyes turn yellow, nausea or vomiting, decreased appetite, pain on the right side of your stomach or you bleed or bruise more easily than normal.
  • Headaches, confusion, seizures, and/or loss of vision
  • Diarrhea 4 times or diarrhea with weakness or lightheadedness

Call your doctor or nurse as soon as possible if any of the following symptoms occur:

  • Wound healing problems
  • Numbness or tingling in hands or feet
  • Painful, red, or swollen areas on your hands or feet.
  • Painful mouth or throat that makes it difficult to eat or drink
  • Prolonged, heavy menstruation
  • Persistent loss of appetite or rapid weight loss of five pounds in a week
  • Fatigue or weakness that interferes with your daily activities.
  • Voice changes or hoarseness

Special Instructions

  • Regorafenib may cause slow wound healing. If you must have emergency surgery or have an accident that results in a wound, tell the treating doctor that you are on regorafinib. Call your cancer doctor as soon as possible for further instructions.

New January 2013

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