Regorafenib is used to treat cancer of the colon and rectum. It is also used to treat liver cancer and a certain cancer of the digestive system (gastrointestinal stromal tumor). It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start taking regorafenib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a low-fat meal as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Keep taking the medication this way as directed by your doctor. Swallow the medication whole. Do not crush, chew, or split the tablets.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Take this medication regularly to get the most benefit from it. Remember to take it at the same time each day that you are scheduled to take it.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

See also Warning section.

Diarrhea, pain/sores in the mouth/throat, changes in taste, dry mouth, loss of appetite, hair loss, voice changes, weight loss, or muscle stiffness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot skin reaction (palmar-plantar erythrodysesthesia). People of Asian descent are at greater risk. Tell your doctor right away if you experience swelling, pain, redness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (for example, hot dishwater, long hot baths). Use a sunscreen and wear protective clothing when outdoors. Avoid pressure on elbows, knees, and soles of feet (such as leaning on elbows, kneeling, taking long walks). Wear loose clothing and comfortable shoes. Depending on how severe your hand-foot reaction is, your doctor may give you an additional medication to reduce the symptoms, or stop or delay your regorafenib treatment.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including:

• slow wound healing
• signs of dehydration (such as extreme thirst, dizziness, decreased urination)
• signs of mineral imbalance (such as muscle cramps/weakness, irregular heartbeat, mental/mood changes)
• signs of infection (such as sore throat that doesn't go away, fever, chills)
• signs of underactive thyroid (weight gain, cold intolerance, unusual tiredness, slow heartbeat)

This medication can cause serious bleeding. Tell your doctor right away if you have any signs of serious bleeding, including:

• easy bleeding/bruising
• severe stomach/abdominal pain
• vomit that is bloody or looks like coffee grounds
• black/tarry stool
• unusual vaginal bleeding
• pink/bloody urine
• coughing up blood

Get medical help right away if you have any very serious side effects, including:

• signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• sudden/severe back pain
• seizure
• severe headache
• confusion
• sudden vision changes
• weakness on one side of the body
• trouble speaking

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

Regorafenib can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking regorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• high blood pressure
• heart disease (such as heart attack, chest pain)
• bleeding problems (such as bleeding of the stomach/intestines)
• blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels)
• recent major surgery/injury

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking regorafenib at least 2 weeks before surgery. This medication may cause wounds to heal more slowly. Follow all instructions about when to stop or restart this medication.

Tell your health care professional that you are using regorafenib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be at greater risk for high blood pressure while using this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using regorafenib. Regorafenib may harm an unborn baby. Men and women using this medication should ask about reliable forms of birth control during treatment and for 2 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• irinotecan
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of regorafenib from your body, which may affect how regorafenib works. Examples include nefazodone, ritonavir, St. John's wort, telithromycin, azole antifungals (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as nelfinavir), rifamycins (such as rifabutin, rifampin), drugs used to treat seizures (such as phenytoin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, complete blood count, blood mineral levels, blood pressure, urine protein test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If you don't remember until the next day, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original bottle at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Once the bottle is opened, this medication expires after 7 weeks. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.