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.
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.
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.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking regorafenib,
Do not eat grapefruit or drink grapefruit juice while taking this medication.
Unless your doctor tells you otherwise, continue your normal diet.
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.
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 ( Web Site) or by phone (1-800-332-1088).
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.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. 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:
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.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.