Stivarga is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Stivarga 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.

Stivarga is usually given after other cancer medications have been tried without success.

Stivarga 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).

You should not use Stivarga if past use has caused severe bleeding or severe liver problems.

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 this medicine.

Before taking this medicine

To make sure Stivarga is safe for you, tell your doctor if you have:

• 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 Stivarga.

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

Take Stivarga exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Stivarga 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.

Stivarga 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 this medicine. Stivarga 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 Stivarga.

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 Stivarga tablets into a daily pill box.

Throw away any Stivarga 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
-Lowest Dose: 80 mg per day
-Duration of Therapy: Until disease progression or unacceptable toxicity

Uses: Treatment of:
-Metastatic colorectal cancer 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 gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate.
-Hepatocellular carcinoma 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
-Lowest Dose: 80 mg per day
-Duration of Therapy: Until disease progression or unacceptable toxicity

Uses: Treatment of:
-Metastatic colorectal cancer 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 gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate.
-Hepatocellular carcinoma 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
-Lowest Dose: 80 mg per day
-Duration of Therapy: Until disease progression or unacceptable toxicity

Uses: Treatment of:
-Metastatic colorectal cancer 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 gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate.
-Hepatocellular carcinoma previously treated with sorafenib.

To make sure Stivarga is safe for you, tell your doctor if you have:

• 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 Stivarga.

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.

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 to Stivarga (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).

Stivarga 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 Stivarga side effects 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 interact with 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.