ust not take two doses on the same day to make up for a dose missed on the previous day. • Inform patients to store medicine in the original container. Do not place medication in daily or weekly pill boxes. Any remaining tablets should be discarded 28 days after opening the bottle. Tightly close bottle after each opening and keep the desiccant in the bottle.
Patient Package Insert
Patient Information
Stivarga (sti-VAR-gah)
(regorafenib)
tablets
Read this Patient Information before you start taking Stivarga and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about Stivarga?
Stivarga can cause serious side effects, including:
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 • change in sleep pattern
What is Stivarga?
Stivarga 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.
Stivarga has not been used to treat children less than 18 years of age.
What should I tell my healthcare provider before taking Stivarga?
Before you take Stivarga, tell your healthcare provider if you:
• have liver problems • have bleeding problems • have high blood pressure • have heart problems or chest pain • plan to have any surgical procedures • have any other medical conditions • 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 your 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. You and your healthcare provider should decide if you will take Stivarga or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Stivarga may affect the way other medicines work, and other medicines may affect how Stivarga works.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take Stivarga?
• Take Stivarga exactly as your healthcare provider tells you. • You will usually take Stivarga 1 time a day for 21 days (3 weeks) and then stop for 7 days (1 week). This is 1 cycle of treatment. Repeat this cycle for as long as your healthcare provider tells you to. • Swallow Stivarga tablets whole. • Take Stivarga at the same time each day with a low-fat breakfast. Exampl
