What is the most important information I should know about regorafenib?
Use birth control to prevent pregnancy, whether you are a man or a woman. Avoid pregnancy for at least 2 months after you stop using this medicine.
You should not use regorafenib if past use has caused severe bleeding or severe liver problems.
Regorafenib can harm your liver. Stop taking this medicine and call your doctor at once if you have nausea, vomiting, sleep problems, dark urine, or jaundice (yellowing of the skin or eyes).
What is regorafenib?
Regorafenib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Regorafenib is used to treat colorectal cancer and liver cancer. It is also used to treat a rare type of tumor that can affect the esophagus, stomach, or intestines.
Regorafenib is usually given after other cancer medications have been tried without success.
Regorafenib may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking regorafenib?
You should not use regorafenib if past use has caused severe bleeding or severe liver problems.
To make sure regorafenib is safe for you, tell your doctor if you have ever had:
- liver disease;
- high blood pressure;
- a bleeding or blood clotting disorder;
- heart disease, chest pain; or
- if you recently had surgery or plan to have surgery.
Do not use regorafenib if you are pregnant. It could harm the unborn baby.
Use birth control to prevent pregnancy while you are receiving regorafenib, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either parent is taking regorafenib. Keep using birth control for at least 2 months after your treatment ends.
It is not known whether regorafenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take regorafenib?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Regorafenib is usually taken daily for 3 weeks followed by 1 week off the medicine. Your doctor will determine how many times you should repeat this treatment cycle.
Regorafenib works best if you take it after a low-fat, low-calorie meal. Swallow the tablet whole with a full glass of water.
Take the medicine at the same time each day.
While using regorafenib, your blood pressure will need to be checked often and you may need frequent blood tests.
If you need surgery, tell the surgeon ahead of time that you are using regorafenib. You may need to stop using the medicine for a short time.
Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Do not put regorafenib tablets into a daily pill box.
Throw away any regorafenib tablets not used within 7 weeks after opening the bottle.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking regorafenib?
Grapefruit and grapefruit juice may interact with regorafenib and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking regorafenib.
Avoid taking an herbal supplement containing St. John's wort at the same time you are taking regorafenib.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
What are the possible side effects of regorafenib?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using regorafenib and call your doctor at once if you have:
- severe headache, vision problems, confusion, thinking problems;
- a seizure;
- rash, blisters, or severe pain in the palms of your hands or the soles of your feet;
-
heart problems --chest pain and severe dizziness, trouble breathing;
-
increased blood pressure --severe headache, blurred vision, pounding in your neck or ears;
-
liver problems --nausea, vomiting, sleep problems, dark urine, jaundice (yellowing of the skin or eyes);
-
perforation (a hole or tear) in your stomach or intestines --fever with severe stomach pain or swelling, nausea, vomiting, increased thirst, decreased urination;
-
severe bleeding --nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, or any bleeding that will not stop; or
-
signs of infection --fever, sore throat, feeling short of breath, cough with mucus, vaginal itching or discharge, pain or burning when you urinate, or redness and swelling anywhere in your body.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- diarrhea, stomach pain, loss of appetite, weight loss;
- fever, infection;
- abnormal liver function tests;
- mouth or throat pain, hoarse voice; or
- feeling weak or tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect regorafenib?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can interact with regorafenib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about regorafenib.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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