Regorafenib

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 and did not work.

Regorafenib may also be used for reasons not mentioned in this medication guide.

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

Regorafenib is usually taken once a day for 3 weeks, followed by a week off the medicine. Your doctor will decide 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, inform your surgeon that you are currently using regorafenib. Regorafenib can cause issues with wound healing, including surgical cuts. You should stop taking this medicine at least 2 weeks before your surgery. Follow your doctor's instructions carefully 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 place regorafenib tablets into a daily pill box.

Dispose of any regorafenib tablets not used within 7 weeks after opening the bottle.

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 right away if you have nausea, vomiting, sleep problems, dark urine, or jaundice (yellowing of the skin or eyes).

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 taking this medicine should use effective birth control to avoid pregnancy. Regorafenib can harm an unborn baby if the mother or father is taking this medicine.

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

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

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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 right away if you have nausea, vomiting, sleep problems, dark urine, or jaundice (yellowing of the skin or eyes).

Also call your doctor immediately if you have:

• headache, confusion, change in mental status;
• vision changes;
• a seizure;
• pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;
• heart problems--chest pain, shortness of breath, feeling faint;
• 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 stopped 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.

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 toxicityUses:-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 toxicityUses:-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 toxicityUses:-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

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

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

Grapefruit and grapefruit juice may interact with regorafenib and cause potentially dangerous effects. Avoid using grapefruit products while taking regorafenib.

Avoid taking an herbal supplement that contains St. John's wort.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medications work less well.

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 new medicine you start or stop using.