Regorafenib Oral tablet
What is this medicine?
REGORAFENIB (RE goe RAF e nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat colorectal cancer and gastrointestinal stromal tumors (GIST).
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
high blood pressure
an unusual or allergic reaction to regorafenib, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not take it more often than directed. Take this medicine with food. Do not take with grapefruit juice. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
This medicine may interact with the following:
St. John’s Wort
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.
You may need blood work done while you are taking this medicine.
Do not become pregnant while taking this medicine or for 2 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 2 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
If you are going to have surgery or any other procedures, tell your doctor you are taking this medicine.
Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
bloody or black, tarry stools
changes in vision
chest pain or chest tightness
feeling faint or lightheaded
red or dark-brown urine
red spots on the skin
right upper belly pain
sores on the hands or feet
spitting up blood or brown material that looks like coffee grounds
unusual bruising or bleeding from the eye, gums, or nose
unusually weak or tired
yellowing of the eyes or skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
loss of appetite
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert