Sachin Sarcoma Society


Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment

What is the most important information I should know about Regorafenib (Stivarga)?

Regorafenib (Stivarga) can cause serious side effects, including

Liver problems. Regorafenib (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

What should I tell my healthcare provider before taking Regorafenib (Stivarga)?

Before you take Regorafenib (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
  • are pregnant or plan to become pregnant. Regorafenib (Stivarga) can harm your unborn baby. Females and males should use effective birth control during treatment with Regorafenib (Stivarga) and for 2 months after your last dose of Regorafenib (Stivarga). Tell your healthcare provider right away if you or your partner becomes pregnant either while taking Regorafenib (Stivarga) or within 2 months after your last dose of Regorafenib (Stivarga).

How should I take Regorafenib (Stivarga)?

Take Regorafenib (Stivarga) exactly as your healthcare provider tells you.

You will usually take Regorafenib (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 Regorafenib (Stivarga) tablets whole

Take Regorafenib (Stivarga) at the same time each day with a low-fat breakfast.

If you miss a dose, take it as soon as you remember on that day. Do not take two doses on the same day to make up for a missed dose.

What are the possible side effects of Regorafenib (Stivarga)?

Severe Bleeding. Regorafenib (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 Regorafenib (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

hand-foot skin reaction and skin rash. (Around 26%) Hand-foot skin reactions can cause redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet. If you get this side effect or a skin rash, your healthcare provider may stop your treatment for some time.

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 Regorafenib (Stivarga).

wound healing problems. If you need to have a surgical procedure, tell your healthcare provider that you are taking Stivarga. You should stop taking Regorafenib (Stivarga) at least 2 weeks before any planned surgery.

The most common side effects of Regorafenib (Stivarga) include:

  • tiredness, weakness, fatigue
  • loss of appetite
  • frequent or loose bowel movements (diarrhea)
  • swelling, pain and redness of the lining in your mouth, throat, stomach and bowel (mucositis)

How do I store Regorafenib (Stivarga)?

  • Store Regorafenib (Stivarga) tablets at room temperature between 68° F to 77° F (20° C to 25° C).
  • Keep Regorafenib (Stivarga) in the bottle that it comes in. Do not put Regorafenib (Stivarga) tablets in a daily or weekly pill box.
  • The Regorafenib (Stivarga) bottle contains a desiccant to help keep your medicine dry. Keep the desiccant in the bottle.
  • Keep the bottle of Regorafenib (Stivarga) tightly closed.
  • Safely throw away (discard) any unused Regorafenib (Stivarga) tablets after 28 days of opening the bottle.