IMPORTANT SAFETY INFORMATION: STIVARGA can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests... Continue reading below
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Understanding side effects with STIVARGA® (regorafenib)

When you’re considering another medication, understanding the side effects is just as important as understanding the benefits. Make sure you talk to your doctor about what to watch for and refer to your starter kit for tips and additional information.


Tips for your experience on STIVARGA
  • Side effects may occur early in treatment. It's important to let your doctor or another member of your treatment team know right away, even if you feel it is minor
  • Your doctor may adjust your dose of STIVARGA, temporarily stop treatment, or permanently discontinue treatment. Sometimes your doctor may stop treatment entirely

Possible side effects
Common side effects
Considerations for hand-foot skin reaction
Considerations for tiredness
Considerations for diarrhea

When taking STIVARGA, certain side effects are possible

The most serious side effects with STIVARGA are:

Serious liver problems

  • STIVARGA can cause liver problems which can be serious and sometimes lead to death
  • Your doctor/nurse will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems
  • Tell your doctor/nurse right away if you get any of these symptoms of liver problems during treatment:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • nausea or vomiting
    • dark "tea-colored" urine
    • changes in sleep pattern

Infection

  • STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung. STIVARGA may also lead to a higher risk of fungal infections of the mucous membrane, skin or the body. Tell your healthcare provider right away if you get:
    • fever
    • severe cough with or without an increase in mucus (sputum) production
    • severe sore throat
    • shortness of breath
    • burning or pain when urinating
    • unusual vaginal discharge or irritation
    • redness, swelling or pain in any part of the body

Severe bleeding

  • STIVARGA can cause bleeding, which can be serious and sometimes lead to death. Tell your doctor/nurse if you have any signs of bleeding while taking STIVARGA, including:
    • vomiting blood or if your vomit looks like coffee grounds
    • pink or brown urine
    • red or black (looks like tar) stools
    • coughing up blood or blood clots
    • menstrual bleeding that is heavier than normal
    • unusual vaginal bleeding
    • nosebleeds that happen often
    • bruising or lightheadedness

A tear in your stomach or intestinal wall (bowel perforation)

  • STIVARGA may cause a tear in your stomach or intestinal wall (bowel perforation) that can be serious and sometimes lead to death
  • Get emergency help right away and call your doctor/nurse if you get:
    • severe pain in your stomach area (abdomen)
    • swelling of the abdomen
    • fever
    • chills
    • nausea
    • vomiting
    • dehydration

Hand-foot skin reaction (HSFR) and severe skin rash

  • Hand-foot skin reactions are common and sometimes can be severe
  • Tell your doctor/nurse right away if you get redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet, or a severe rash

High blood pressure

  • Your blood pressure should be checked every week for the first 6 weeks of starting STIVARGA.
  • Your blood pressure should be checked regularly and any high blood pressure should be treated during treatment with STIVARGA.
  • Tell your doctor/nurse if you have severe headaches, light-headedness, or changes in your vision

Decreased blood flow to the heart and heart attack

  • Get emergency help right away and call your doctor/nurse if you:
    • have chest pains
    • have shortness of breath
    • feel dizzy or feel like passing out

A condition called reversible posterior leukoencephalopathy syndrome (RPLS)

  • Get emergency help right away and call your doctor/nurse if you get:
    • severe headaches
    • seizure
    • confusion
    • changes in vision
    • problems thinking

Wound healing problems

  • If you need to have surgery, tell the healthcare provider that you are taking STIVARGA
  • You should stop taking STIVARGA at least 2 weeks before any planned surgery

Be Alert

Talk to your doctor or nurse about any side effects you are having


Indications

STIVARGA (regorafenib) is a prescription medicine used to treat people with:

It is not known if STIVARGA is safe and effective in children less than 18 years of age.

Important Safety Information

STIVARGA (regorafenib) can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems. Tell your healthcare provider right away if you experience yellowing of your skin or the white part of your eyes, nausea, vomiting, dark urine, or change in your sleep pattern.

Before taking STIVARGA, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Avoid drinking grapefruit juice and taking St. John’s Wort while taking STIVARGA.

STIVARGA may cause serious side effects, including:

The most common side effects with STIVARGA include pain including stomach-area (abdomen); tiredness, weakness, fatigue; diarrhea (frequent or loose bowel movements); decreased appetite; infection; voice change or hoarseness; increase in certain liver function tests; fever; swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis); and weight loss.

For important risk and use information about STIVARGA, please see the full Prescribing Information, including Boxed Warning.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.