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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 your doctor and the laboratory. Your doctor will order certain lab tests to check your response to regorafenib.
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. 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 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 breakfast 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.
Take regorafenib with a low-fat breakfast that contains less than 30% of calories from fat (each gram of fat contains 9 calories). Examples of a low-fat breakfast include 2 slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly, and 8 ounces of skim milk (about 320 calories and 8 grams of fat); or 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jam, apple juice, and 1 cup of coffee or tea (about 520 calories and 2 grams of fat). Talk to your doctor about other low-fat breakfasts to eat with regorafenib.
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 medicine?
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 [at Web Site] or by phone [1-800-332-1088].
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). Throw away any unused tablets 28 days after the bottle is first opened. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
What OTHER INFORMATION should I know?
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.