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Regorafenib may cause liver damage, which may be severe or life-threatening. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes, nausea, vomiting, dark colored urine, pain in the upper right part of the stomach, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, flu-like symptoms, or a change in sleep habits.
Keep all appointments with the laboratory. Your doctor will order certain lab tests before and during your treatment to be sure that it is safe for you to take regorafenib and to check your body's response to the medication.
WHY is this medicine prescribed?
Regorafenib is used to treat colon and rectal cancer (cancer that begins in the large intestine or the rectum) that has spread to other parts of the body in people who have not been treated successfully with certain other medications. It is also used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine [bowel], or esophagus [tube that connects the throat with the stomach]) in people who were not treated successfully with certain other medications. Regorafenib is also used to treat hepatocellular carcinoma (HCC; a type of liver cancer) in people who were previously treated with sorafenib (Nexafar). Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to slow or stop the spread of cancer cells.
HOW should this medicine be used?
Regorafenib comes as a tablet to take by mouth. It is usually taken with a low-fat meal (containing under 600 calories and less than 30% of calories from fat) once a day for 3 weeks and then skipped for 1 week. This treatment period is called a cycle, and the cycle may be repeated for as long as your doctor recommends. Take regorafenib at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take regorafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
Your doctor may decrease your dose of regorafenib or tell you to stop taking regorafenib for a period of time during your treatment. This will depend on how well the medication works for you and any side effects you may experience. Continue to take regorafenib even if you feel well. Do not stop taking regorafenib without talking to your doctor.
Regorafenib is not available at retail pharmacies. Your medication will be mailed to you or to your doctor from a specialty pharmacy. Ask your doctor if you have any questions about how you will receive your medication.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking regorafenib,
What SPECIAL DIETARY instructions should I follow?
Do not eat grapefruit or drink grapefruit juice while taking this medication.
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
If you miss a dose of regorafenib, take the missed dose as soon as you remember it on that day. Do not take two doses on the same day to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Regorafenib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
Regorafenib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not place the tablets in other containers, such as daily or weekly pill boxes, and do not remove the desiccant (drying agent) from the container. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of any unused tablets 7 weeks after the bottle is first opened.
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
What OTHER INFORMATION should I know?
Keep all appointments with your doctor. Your doctor will check your blood pressure before you begin taking regorafenib and regularly during your treatment.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: May 24, 2017.