"The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved t"...
Stivarga Patient Information Including Side Effects
Brand Names: Stivarga
Generic Name: regorafenib (Pronunciation: RE goe RAF e nib)
- What is regorafenib (Stivarga)?
- What are the possible side effects of regorafenib (Stivarga)?
- What is the most important information I should know about regorafenib (Stivarga)?
- What should I discuss with my healthcare provider before taking regorafenib (Stivarga)?
- How should I take regorafenib (Stivarga)?
- What happens if I miss a dose (Stivarga)?
- What happens if I overdose (Stivarga)?
- What should I avoid while taking regorafenib (Stivarga)?
- What other drugs will affect regorafenib (Stivarga)?
- Where can I get more information?
What is regorafenib (Stivarga)?
Regorafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Regorafenib 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.
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.
What are the possible side effects of regorafenib (Stivarga)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using regorafenib and call your doctor at once if you have:
- fever, chills, flu symptoms, mouth sores, severe or ongoing vomiting or diarrhea;
- feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
- blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;
- heavy menstrual periods or abnormal vaginal bleeding;
- any bleeding that will not stop;
- chest pain and severe dizziness, fainting, feeling short of breath;
- headache, confusion, change in mental status, vision loss, seizure (convulsions);
- upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- dangerously high blood pressure (blurred vision, buzzing in your ears, anxiety, uneven heartbeats);
- rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
- any wound that won't heal; or
- 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 side effects may include:
- diarrhea, stomach pain, weight loss;
- 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.
Read the Stivarga (regorafenib tablets) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about regorafenib (Stivarga)?
You should not use regorafenib if past use has caused severe bleeding, or if you have severe liver disease.
Regorafenib 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).
Regorafenib 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.
Additional Stivarga Information
- Stivarga Drug Interactions Center: regorafenib oral
- Stivarga Side Effects Center
- Stivarga FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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