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.
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 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 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 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
- nosebleeds that happen often
- bruising
- 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 healthcare provider if you get:
- severe pain in your stomach area (abdomen)
- swelling of the abdomen
- fever
- chills
-
- nausea
- vomiting
- dehydration
Hand-foot skin reaction (HFSR) 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 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 healthcare provider if you have severe headaches, lightheadedness, or changes in your vision
Decreased blood flow to the heart and heart attack
- Get emergency help right away and call your healthcare provider 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 healthcare provider if you get:
- severe headaches
- seizure
- confusion
-
- changes in vision
- problems thinking
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
Be Alert
Talk to your healthcare provider about any side effects you are having.
Most common side effects
People in the clinical trials experienced side effects when taking STIVARGA. Side effects with STIVARGA may occur early on in treatment.
In clinical trials, the most common side effects with STIVARGA included:
| stomach-area (abdomen) pain | voice change or hoarseness |
|---|---|
| tiredness, weakness, fatigue | increase in certain liver function tests |
| diarrhea (frequent or loose bowel movements) | fever |
| decreased appetite | swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis) |
| infection | weight loss |
Stay in Tune
You know your body best! So be on the lookout for side effects. Tell your healthcare provider about any side effect that bothers you or does not go away.
Treatment balance
The goal of therapy with STIVARGA is to balance potential treatment benefit with potential side effects.
That’s why it is important to communicate with your treatment team. Your doctor may change your dose, temporarily stop, or permanently stop STIVARGA if you have certain side effects. Your doctor will decide which treatment changes are right for you.
