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.

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 regorafenib.

Regorafenib can cause serious or life-threatening liver problems. Call your doctor at once if you have nausea, vomiting, sleep problems, dark urine, or jaundice (yellowing of the skin or eyes).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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.

Your blood pressure will need to be checked often. Your liver function will also need to be checked.

If you need surgery, tell your surgeon you currently use regorafenib. Regorafenib can cause problems with wounds healing, including surgical incisions. You should stop taking this medicine at least 2 weeks before you have surgery. Carefully follow your doctor's instructions about when to stop and start taking regorafenib.

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.

Usual Adult Dose for Colorectal Cancer:

160 mg orally once a day for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity

Uses:
-Metastatic colorectal cancer (CRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy if RAS wild-type
-Locally advanced, unresectable or metastatic GI stromal tumor (GIST) previously treated with imatinib mesylate and sunitinib malate
-Hepatocellular carcinoma (HCC) previously treated with sorafenib

Usual Adult Dose for Gastrointestinal Stromal Tumor:

160 mg orally once a day for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity

Uses:
-Metastatic colorectal cancer (CRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy if RAS wild-type
-Locally advanced, unresectable or metastatic GI stromal tumor (GIST) previously treated with imatinib mesylate and sunitinib malate
-Hepatocellular carcinoma (HCC) previously treated with sorafenib

Usual Adult Dose for Hepatocellular Carcinoma:

160 mg orally once a day for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity

Uses:
-Metastatic colorectal cancer (CRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy if RAS wild-type
-Locally advanced, unresectable or metastatic GI stromal tumor (GIST) previously treated with imatinib mesylate and sunitinib malate
-Hepatocellular carcinoma (HCC) previously treated with sorafenib

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.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Regorafenib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 2 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using regorafenib.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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 (http://goo.gl/c4Rm4p) 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. http://www.upandaway.org

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

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.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Regorafenib can cause serious or life-threatening liver problems. Call your doctor at once if you have nausea, vomiting, sleep problems, dark urine, or jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

• headache, confusion, change in mental status;

• vision changes;

• a seizure;

• pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet;

• heart problems--chest pain, shortness of breath, feeling like you might pass out;

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;

• perforation (a hole or tear) in your stomach or intestines--fever, chills, severe stomach pain or swelling, nausea, vomiting, increased thirst, decreased urination;

• severe bleeding--bruising, 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 or without 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 of regorafenib may include:

• diarrhea, nausea, stomach pain;

• loss of appetite, weight loss;

• increased blood pressure;

• fever, infection;

• abnormal liver function tests;

• pain or redness in your mouth or throat, 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.

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 affect regorafenib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.