Regorafenib tablets

What is this medication?

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, gastrointestinal stromal tumors (GIST), and liver cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Stivarga

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• heart disease
• high blood pressure
• liver disease
• recent surgery
• an unusual or allergic reaction to regorafenib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

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 have 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 medication?

This medicine may interact with the following:

• carbamazepine
• irinotecan
• itraconazole
• ketoconazole
• phenobarbital
• phenytoin
• posaconazole
• rifampin
• St. John’s Wort
• telithromycin
• voriconazole
• warfarin

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 medication?

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 or for 2 weeks after stopping it.

Before having surgery, talk to your health care provider to make sure it is ok. This drug can increase the risk of poor healing of your surgical site or wound. You will need to stop this drug for 2 weeks before surgery. After surgery, wait at least 2 weeks before restarting this drug. Make sure the surgical site or wound is healed enough before restarting this drug. Talk to your health care provider if questions.

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 medication?

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
• breathing problems
• changes in vision
• chest pain or chest tightness
• confusion
• dizziness
• feeling faint or lightheaded
• high fever
• light-colored stools
• nausea, vomiting
• red or dark-brown urine
• red spots on the skin
• right upper belly pain
• seizures
• severe headache
• sores on the hands or feet
• spitting up blood or brown material that looks like coffee grounds
• stomach pain
• 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 to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• hoarseness
• loss of appetite
• sore throat
• tiredness
• weight loss

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 medication?

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 7 weeks after opening the bottle.

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.