Managing side effects

Management of hand-foot skin reaction (HFSR), tiredness, and diarrhea when taking STIVARGA^® (regorafenib)

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

Considerations for hand-foot skin reaction

HFSR: What you need to know

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 healthcare provider 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 by reducing your dose, temporarily discontinuing, or permanently discontinuing STIVARGA.

Grade 1*

Grade 2*

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 healthcare provider. You may need to see a dermatologist (skin doctor).

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

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 healthcare provider right away about any side effects you are having.

Considerations for tiredness

Tiredness: What you can do

Feeling tired is common when you have cancer. STIVARGA may also make you feel tired.

If you are feeling tired, try “REST”:

Reprioritize daily tasks to do your most important ones when you have the most energy; don't worry about doing less important things if you are tired.

Exercise lightly or remain active. Follow your doctor’s guidelines for activity.

Stay awake during the day, so you can sleep well at night.

Take time with friends and for activities you enjoy—like listening to music or reading.

Considerations for diarrhea

Diarrhea: What you can do

STIVARGA may cause diarrhea. If you get diarrhea, tell your healthcare provider right away. You might need treatment to replace important fluids in your body or to keep you from losing too much weight.

Following these tips can help treat diarrhea:

Eat several small meals each day, instead of 2 or 3 large ones
- Try bland foods, like bananas, rice, applesauce, and toast
Drink plenty of water, but stay away from hot or iced drinks
Stay away from spicy foods, dairy products, caffeine, and alcohol
Take diarrhea medicine as directed by your healthcare provider

Be Alert

Talk to your healthcare provider about any side effects you are having.

View all possible side effects

Learn about side effects you may experience while taking STIVARGA

Stay in the know

Get more information on STIVARGA materials and support groups

INDICATIONS

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

colon or rectal cancer that has spread to other parts of the body and for which they have received previous treatment with certain chemotherapy medicines
a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumor) that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines
a type of liver cancer called hepatocellular carcinoma (HCC) in people who have been previously treated with sorafenib

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:

have liver problems in addition to liver cancer
have bleeding problems
have high blood pressure
have heart problems or chest pain
plan to have surgery or have had a recent surgery. You should stop taking STIVARGA at least 2 weeks before planned surgery
are pregnant or plan to become pregnant. STIVARGA can harm your unborn baby. Females and males should use effective birth control during treatment with STIVARGA and for 2 months after their last dose of STIVARGA. Tell your healthcare provider right away if you or your partner becomes pregnant either while taking STIVARGA or within 2 months after your last dose of STIVARGA
are breast-feeding or plan to breast-feed. It is not known if STIVARGA passes into your breast milk. Do not breastfeed during treatment with STIVARGA and for 2 weeks after your final dose of STIVARGA

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:

Infection. STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung. STIVARGA may 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 healthcare provider 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, nose bleeds that happen often, bruising, and lightheadedness
a tear in your stomach or intestinal wall (bowel perforation). STIVARGA may cause a tear in your stomach or intestinal wall that can be serious and sometimes lead to death. Contact your healthcare provider immediately if you notice severe pains or swelling in your stomach area (abdomen), fever, chills, nausea, vomiting, or dehydration
a skin problem called hand-foot skin reaction and severe skin rash. Hand-foot skin reactions are common and sometimes can be severe. Tell your healthcare provider right away if you get redness, pain, blisters, bleeding, or swelling on the palms of your hands and 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 while you are receiving STIVARGA. Tell your healthcare provider if you have severe headaches, light-headedness, or changes in your vision
decreased blood flow to the heart and heart attack. Get emergency help if you have chest pain, have shortness of breath, feel dizzy, or feel like passing out
a condition called reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you get severe headaches, seizure, confusion, change in vision, or problems thinking
risk of wound healing problems. Wounds may not heal properly during STIVARGA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with STIVARGA.
- You should stop taking STIVARGA at least 2 weeks before planned surgery.
- Your healthcare provider should tell you when you may start taking STIVARGA again after surgery.

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.

This site is intended for US audiences only.

Last updated on March 2024

Managing side effects

Management of hand-foot skin reaction (HFSR), tiredness, and diarrhea when taking STIVARGA® (regorafenib)