Important Safety Information
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 experience yellowing of your skin or the white part of your eyes, nausea, vomiting, dark urine, or changes in your sleep pattern.
Before taking STIVARGA, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- have bleeding problems
- have high blood pressure
- have heart problems or chest pain
- plan to have surgery or have had recent surgery
- are pregnant or plan to become pregnant. STIVARGA can harm your unborn baby. Females and males with female partners who can become pregnant 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 breastfeeding or plan to breastfeed. 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 during treatment with STIVARGA.
STIVARGA may cause serious side effects, including:
- severe bleeding. STIVARGA can cause bleeding, which can be serious and sometimes lead to death. Tell your doctor 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 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 or soles of your feet, or a severe rash
- high blood pressure. Your blood pressure should be checked every week for the first 6 week 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, light-headedness, or changes in your vision
- decreased blood flow to the heart and heart attack. Get emergency help if you have symptoms such as chest pain, 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
- a tear in your stomach or intestinal wall (bowel perforation). STIVARGA may cause a tear in your stomach or bowel perforation that can be serious and sometimes lead to death. Contact your healthcare provider immediately if you have severe pains or swelling in your stomach area (abdomen), high fever, chills, nausea, vomiting, or dehydration
- wound healing problems. If you need to have a surgical procedure, tell your healthcare provider that you are taking STIVARGA. You should stop taking STIVARGA at least 2 weeks before any planned surgery
The most common side effects with STIVARGA include tiredness, weakness, fatigue; diarrhea (frequent or loose bowel movements); loss of appetite; swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis); voice changes or hoarseness; infection; pain in other parts of your body; weight loss; abdomen (stomach-area) pain; fever; and nausea.
These are not all of the possible side effects of STIVARGA. For more information, ask your healthcare provider or pharmacist.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with STIVARGA if you have certain side effects.
Tell your doctor if you have any side effects that bother you or that do not go away.
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.