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)

  • Bone marrow depression. This is a decrease in the number of white blood cells, red blood cells, and platelets. This may raise your risk of infection, make you tired and weak (fatigue), and raise your risk of bleeding.
  • High blood pressure. Your doctor will check your blood pressure as needed.
  • Loose bowel movements (diarrhea) that may last for a few days 
  • 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 hurt.
  • Generalized weakness and discomfort (aches or pains)
  • Decreased  appetite (decreased hunger)
  • Electrolyte changes: Your blood will be checked for electrolyte changes as needed.

Possible Side Effects (Less Common)

  • Changes in your liver function. Your doctor will check your liver function as needed.
  • Chest pain or symptoms of a heart attack. Most heart attacks involve pain in the center of the chest that lasts more than a few minutes. The pain may go away and come back or it can be constant. It can feel like pressure, squeezing, fullness, or pain. Sometimes pain is felt in one or both arms, the back, neck, jaw, or stomach. If any of these symptoms last 2 minutes, call 911. 
  • Slow wound healing 

Allergic Reactions

Allergic reactions, including anaphylaxis are rare but may happen in some patients. Signs of allergic reactions to this drug may be swelling of the face, feeling like your tongue or throat are swelling, trouble breathing, rash, itching, fever, chills, feeling dizzy, and/or feeling that your heart is beating in a fast or not normal way. If you get any of these symptoms, do not take another dose of this drug. You should get urgent medical treatment.

Treating Side Effects

  • Drink 6-8 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. Also avoid alcohol and smoking because they can irritate your mouth and throat.
  • If you get a rash do not put anything on it unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if the rash bothers you.
  • Ask your doctor for medicines to stop or lessen loose bowel movements (diarrhea)

Important Information

  • Swallow the medicine whole. Do not chew, break, or crush it.
  • 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.
  • Keep the bottle of regorafenib tightly closed and safely throw away any unused regorafenib tablets 28 days after opening the bottle.
  • Missed dose: If you miss a dose, take it as soon as you remember. Do not take it if it is close (within 12 hours) of your next dose. Just take the next dose at your normal time. Do not take more than 1 dose at a time.

Food and Drug Interactions

  • There are known interactions of regorafenib with grapefruit. Do not eat grapefruit or drink grapefruit juice while taking this drug.
  • Talk with your doctor about taking St. John’s Wort, garlic, ginseng, and ginkgo. Tell your doctor and pharmacist about all the medicines and dietary supplements (vitamins, minerals, herbs and others) that you are taking at this time. The safety and use of dietary supplements and alternative diets are often not known. Using these might 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 help.

Other Instructions

Regorafenib may cause slow wound healing. It should not be given within 28 days of surgery or any test and/or procedure needing conscious sedation. If you must have emergency surgery or have an accident that results in a wound, tell the doctor that you are taking regorafenib.  Call your cancer doctor as soon as possible for further instructions.

When to Call the Doctor

Call your doctor or nurse right away if you have any of these symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Easy bleeding or bruising
  • Wheezing or trouble breathing
  • Rash or itching
  • Feeling dizzy or lightheaded
  • Feeling that your heart is beating in a fast or not normal way (palpitations)
  • Loose bowel movements (diarrhea) more than 4 times in one day or diarrhea with weakness or lightheadedness
  • Blurred vision or other changes in eyesight
  • Pain when passing urine; blood in urine
  • Pain in your lower back or side
  • Feeling confused or agitated
  • Nausea that stops you from eating or drinking
  • Throwing up (vomiting) more than 3 times in one day
  • Chest pain or symptoms of a heart attack. Most heart attacks involve pain in the center of the chest that lasts more than a few minutes. The pain may go away and come back. It can feel like pressure, squeezing, fullness, or pain. Sometimes pain is felt in one or both arms, the back, neck, jaw, or stomach. If any of these symptoms last 2 minutes, call 911.
  • Symptoms of a stroke such as sudden numbness or weakness of your face, arm, or leg, mostly on one side of your body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, feeling dizzy, loss of balance or coordination; or sudden, bad headache with no known cause.  If you have any of these symptoms for 2 minutes, call 911. 
  • Signs of liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin

Call your doctor or nurse as soon as possible if any of these symptoms happen:

  • Change in hearing, ringing in the ears
  • Decreased urine
  • Unusual thirst or passing urine often
  • Pain in your mouth or throat that makes it hard to eat or drink
  • Nausea that is not relieved by prescribed medicines
  • Rash that is not relieved by prescribed medicines
  • Heavy menstrual period that lasts longer than normal
  • Numbness, tingling, decreased sensation or weakness in fingers, toes, arms, or legs
  • Trouble walking or changes in the way you walk, feeling clumsy when buttoning clothes, opening jars, or other routine hand motions
  • Swelling of legs, ankles, or feet
  • Weight gain of 5 pounds in one week (fluid retention)
  • Lasting loss of appetite or rapid weight loss of five pounds in a week
  • Fatigue that interferes with your daily activities
  • Headache that does not go away
  • Painful, red, or swollen areas on your hands or feet.
  • No bowel movement for 3 days or you feel uncomfortable
  • Extreme weakness that interferes with normal activities

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 for you to talk about the effects of this drug therapy on future pregnancies. Also, a genetic counselor can look at the possible risk of problems in the unborn baby due to this medicine if an exposure happens during pregnancy.
  • Breast-feeding warning: It is not known if this drug passes into breast milk.  For this reason, women should talk to their doctor about the risks and benefits of breast feeding during treatment with this drug because this drug may enter the breast milk and badly harm a breast feeding baby.

Revised November 2014

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