Stivarga (regorafenib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Stivarga is used to treat colorectal 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.
Important information
You should not use Stivarga if past use has caused severe bleeding, or if you have severe liver disease.
Stivarga can harm your liver. Stop taking this medicine and call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Stivarga can also cause severe bleeding. Call your doctor if you have blood in your urine or stools, abnormal vaginal bleeding, coughing up blood, or any bleeding that will not stop.
Before taking this medicine
You should not use Stivarga if past use has caused severe bleeding, or if you have severe liver disease.
To make sure Stivarga is safe for you, tell your doctor if you have:
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liver disease;
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heart disease, high blood pressure;
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bleeding or blood clotting disorder such as hemophilia;
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a history of recent heart attack or stroke (including "mini-stroke"); or
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if you have recently had surgery.
Do not use Stivarga if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
Use birth control to prevent pregnancy while you are receiving Stivarga, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either parent is taking Stivarga. Keep using birth control for at least 2 weeks after your treatment ends.
It is not known whether regorafenib passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Stivarga?
Take Stivarga exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
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 with a low-fat breakfast.
Do not crush, chew, or break a tablet. Swallow it whole.
While using Stivarga, your blood pressure will need to be checked often. You may also need frequent blood tests at your doctor"s office.
If you need surgery, tell the surgeon ahead of time that you are using regorafenib. You may need to stop using the medicine at least 2 weeks before your surgery. Follow your doctor"s instructions.
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.
Throw away any Stivarga tablets not used within 28 days after opening the bottle.
Stivarga dosing information
Usual Adult Dose for Colorectal Cancer:
Initial dose: 160 mg (four 40 mg tablets) orally once daily for the first 21 days of each 28-day cycle.
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity.
Usual Adult Dose for Gastrointestinal Stromal Tumor:
Initial dose: 160 mg (four 40 mg tablets) orally once daily for the first 21 days of each 28-day cycle.
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Stivarga?
Grapefruit and grapefruit juice may interact with regorafenib and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking Stivarga.
Stivarga side effects
Get emergency medical help if you have signs of an allergic reaction to Stivarga: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Stivarga and call your doctor at once if you have:
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headache, confusion, change in mental status, vision loss, seizure (convulsions);
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chest pain and severe dizziness, fainting, feeling short of breath;
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a high fever with severe stomach pain or swelling;
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rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
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severe bleeding - heavy menstrual periods or abnormal vaginal bleeding, blood in your urine or stools, coughing up blood, or any bleeding that will not stop;
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signs of infection - fever, chills, flu symptoms, mouth sores, severe or ongoing vomiting or diarrhea;
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dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
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signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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dangerously high blood pressure - blurred vision, buzzing in your ears, anxiety, uneven heartbeats; or
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severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Stivarga side effects may include:
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nausea, diarrhea, stomach pain, loss of appetite, weight loss;
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infection;
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mouth or throat pain, hoarse voice; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Stivarga?
Many drugs can interact with regorafenib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Stivarga. Give a list of all your medicines to any healthcare provider who treats you.
