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
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Common side effects
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Considerations for hand-foot skin reaction
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Considerations for tiredness
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Considerations for diarrhea
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Hand-foot skin reaction: What you need to know

Hand-foot skin reaction (HFSR) is a common side effect of treatment with STIVARGA. You may not recognize that you have HFSR if you don’t know what to look for. That’s why it is important to catch symptoms early on—and let your treatment team know about them.

Tell your doctor or nurse right away if you have even mild symptoms of these skin changes, as they could be signs of HFSR:

Changes in Skin
Sensation
Numbness, burning, tingling, or “pins and needles” feelings
Sensitivity
Increased sensitivity or sensitivity to hot objects
Appearance
Redness or swelling
Texture
Calluses (hard layers of skin) on the palms of hands or balls/soles of feet, blisters, dry or cracked skin, or flaking or peeling skin

Tell Your Team

Tell your treatment team right away if you have signs of HFSR on your hands or feet. They will determine how severe your symptoms are and can work with you to help manage them either by reducing your dose, temporarily discontinuing, or permanently discontinuing STIVARGA.

Foot
Grade 1*
Hand
Grade 2*
Toe
Grade 3*

Not every skin reaction is HFSR

You may notice a rash on your face or body when taking STIVARGA. Rash is different from HFSR, because it does not give you calluses on your feet or hands. A rash can be reddish, itchy, or tender. It can also include small blister-like bumps. If you have rash, talk with your doctor/nurse. You may need to see a dermatologist (skin doctor).

*Photos courtesy of S. Karger AG. Reproduced with patients' permission.

Rash
Rash*

CARE for HFSR

When thinking about HFSR, remember to "CARE"

Check for and treat any new calluses. Inspect your skin regularly. You can soak your feet weekly for 20-30 minutes in Epsom salts (magnesium sulfate). After soaking, gently pumice any callused skin. Thick calluses require a consult with a podiatrist.

Add cushioning (such as gloves or handle grips) when doing activities that increase pressure on hands. This includes cooking, gardening, sports, and home repair.

Relieve pressure on feet by wearing comfortable, well-padded shoes and loosening laces.

Exfoliate and moisturize skin to keep it soft and well hydrated.


Be Alert

Talk to your doctor or nurse right away 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.