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Regorafenib (Stivarga®)

About This Drug

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

Possible Side Effects

  • Soreness of the mouth and throat. You may have red areas, white patches, or sores that hurt.
  • Nausea
  • Pain in your abdomen
  • Diarrhea (loose bowel movements)
  • Tiredness and weakness
  • Fever
  • Infection
  • Changes in your liver function
  • Pain
  • Hoarse voice
  • Decreased appetite (decreased hunger)
  • Weight loss
  • Rash
  • Hand-foot syndrome. The palms of your hands or soles of your feet may tingle, become numb, painful, swollen, or red.
  • High blood pressure

Note: Each of the side effects above was reported in 20% or greater of patients treated with regorafenib. Not all possible side effects are included above.

Warnings and Precautions

  • Severe infections, including viral, bacterial and fungal, which can be life-threatening
  • Changes in your central nervous system can happen. The central nervous system is made up of your brain and spinal cord. You could feel extreme tiredness, agitation, confusion, hallucinations (see or hear things that are not there), have trouble understanding or speaking, loss of control of your bowels or bladder, eyesight changes, numbness or lack of strength to your arms, legs, face, or body, seizures or coma. If you start to have any of these symptoms let your doctor know right away.
  • Changes in your heart function and risk for heart attack
  • Abnormal bleeding – symptoms may be coughing up blood, throwing up blood (may look like coffee grounds), red or black tarry bowel movements, abnormally heavy menstrual flow, nosebleeds or any other unusual bleeding.
  • Risk of developing a hole in your stomach, small and/or large intestine and/or an abnormal opening in stomach, intestine or esophagus (fistula). Symptoms of a fistula may be: severe abdominal pain or difficulty swallowing.
  • Changes in your liver function, which can cause liver failure and be life-threatening
  • Severe allergic skin reaction. You may develop blisters on your skin that are filled with fluid or a severe red rash all over your body that may be painful.
  • Severe high blood pressure
  • Slow wound healing

Note: Some of the side effects above are very rare. If you have concerns and/or questions, please discuss them with your medical team.

Important Information

  • Regorafenib may cause slow wound healing. It should not be given within 14 days of surgery. If you must have emergency surgery or have an accident that results in a wound, tell the doctor that you are on regorafenib.

How to Take Your Medication

  • Swallow the medicine whole with water after a low-fat meal (less than 600 calories and less than 30% fat).
  • Take this medicine at the same time each day.
  • Missed dose: If you miss a dose, take it as soon as you think about it on that day. If you vomit a dose, take your next dose at the regular time, and contact your physician. Do not take 2 doses at the same time and do not double up on the next dose.
  • Handling: Wash your hands after handling your medicine, your caretakers should not handle your medicine with bare hands and should wear latex gloves.
  • This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
  • Storage: Store this medicine in the original container at room temperature. Do not remove the desiccant and keep bottle tightly closed after first opening. Discard any remaining medicine 7 weeks after opening the bottle.
  • Disposal of unused medicine: Do not flush any expired and/or unused medicine down the toilet or drain unless you are specifically instructed to do so on the medication label. Some facilities have take-back programs and/or other options. If you do not have a take-back program in your area, then please discuss with your nurse or your doctor how to dispose of unused medicine.

Treating Side Effects

  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • Manage tiredness by pacing your activities for the day.
  • Be sure to include periods of rest between energy-draining activities.
  • Mouth care is very important. Your mouth care should consist of routine, 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 1/2 teaspoon of baking soda in 8 ounces of water. This should be done at least after each meal and at bedtime.
  • If you have mouth sores, avoid mouthwash that has alcohol. Also avoid alcohol and smoking because they can bother your mouth and throat.
  • If you throw up or have loose bowel movements, you should drink more fluids so that you do not become dehydrated (lack of water in the body from losing too much fluid).
  • If you have diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
  • Ask your nurse or doctor about medicine that can lessen or stop your diarrhea.
  • To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help stop or lessen these symptoms.
  • To help with weight loss, drink fluids that contribute calories (whole milk, juice, soft drinks, sweetened beverages, milkshakes, and nutritional supplements) instead of water.
  • To help with decreased appetite, eat small, frequent meals. Eat foods high in calories and protein, such as meat, poultry, fish, dry beans, tofu, eggs, nuts, milk, yogurt, cheese, ice cream, pudding, and nutritional supplements.
  • Consider using sauces and spices to increase taste. Daily exercise, with your doctor’s approval, may increase your appetite.
  • Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
  • 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 your rash bothers you.
  • Avoid sun exposure and apply sunscreen routinely when outdoors.

Food and Drug Interactions

  • Avoid grapefruit or grapefruit juice while taking this medicine. Grapefruit and grapefruit juice may raise the levels of regorafenib in your body. This could make side effects worse.
  • Check with your doctor or pharmacist about all other prescription medicines and over-the-counter medicines and dietary supplements (vitamins, minerals, herbs and others) you are taking before starting this medicine as there are known drug interactions with regorafenib. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplements to make sure that there are no interactions.
  • Avoid the use of St. John’s Wort while taking regorafenib as this may lower the levels of the drug in your body, which can make it less effective.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.4° F (38° C) or higher
  • Chills
  • Feeling dizzy or lightheaded
  • Easy bleeding or bruising
  • Confusion and/or agitation
  • Symptoms of a seizure such as confusion, blacking out, passing out, loss of hearing or vision, blurred vision, unusual smells or tastes (such as burning rubber), trouble talking, tremors or shaking in parts or all of the body, repeated body movements, tense muscles that do not relax, and loss of control of urine and bowels. If you or your family member suspects you are having a seizure, call 911 right away.
  • Hallucinations
  • Trouble understanding or speaking
  • Blurry vision or changes in your eyesight
  • Numbness or lack of strength to your arms, legs, face, or body
  • Tiredness that interferes with your daily activities
  • Headache that does not go away
  • Coughing up blood
  • 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.
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Severe abdominal pain that does not go away
  • Difficulty swallowing
  • Lasting loss of appetite or rapid weight loss of five pounds in a week
  • Diarrhea, 4 times in one day or diarrhea with lack of strength or a feeling of being dizzy
  • Decreased urine
  • Blood in your urine, vomit (bright red or coffee-ground) and/or stools (bright red, or black/tarry)
  • Signs of possible liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin
  • A new rash or a rash that is not relieved by prescribed medicines
  • Pain in your mouth or throat that makes it hard to eat or drink
  • Painful, red, or swollen areas on your hands or feet
  • Numbness and/or tingling in your hands and/or feet
  • If you think you may be pregnant or may have impregnated your partner

Reproduction Warnings

  • Pregnancy warning: This drug can have harmful effects on the unborn baby. Women of childbearing potential should use effective methods of birth control during your cancer treatment and for 2 months after treatment. Men with female partners of childbearing potential should use effective methods of birth control during your cancer treatment and for 2 months after your cancer treatment. Let your doctor know right away if you think you may be pregnant or may have impregnated your partner.
  • Breastfeeding warning: Women should not breastfeed during treatment and for 2 weeks after treatment because this drug could enter the breast milk and cause harm to a breastfeeding baby.
  • Fertility warning: In men and women both, this drug may affect your ability to have children in the future. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.

Revised August 2019

This patient information was developed by Via Oncology, LLC © 2019. This information is not intended to be used as a substitute for professional medical advice, diagnosis, or treatment. You should not rely entirely on this information for your health care needs. Ask your own doctor or health care provider any specific medical questions that you have.

CLIENT acknowledges that the Via Pathways and Via Portal are information management tools only, and that Via Oncology, LLC has not represented the Via Pathways or Via Portal as having the ability to diagnose disease, prescribe treatment, or perform any other tasks that constitute the practice of medicine. The clinical information contained in the Via Pathways and Via Portal are intended as a supplement to, and not a substitute for, the knowledge, expertise, skill, and judgment of physicians, pharmacists and other healthcare professionals involved with patient care at CLIENT facilities.