regorafenib

What is the most important information I should know about regorafenib?

What is regorafenib?

Regorafenib is used to treat colorectal cancer and liver cancer. It is also used to treat a rare type of tumor that can affect the esophagus, stomach, or intestines.

Regorafenib is usually given after other cancer medications have been tried without success.

Regorafenib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking regorafenib?

Tell your doctor if you have ever had:

• liver disease;
• high blood pressure;
• a bleeding or blood clotting disorder;
• heart disease, chest pain; or
• if you recently had surgery or plan to have surgery.

Keep using birth control for at least 2 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using regorafenib.

How should I take regorafenib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Regorafenib is usually taken daily for 3 weeks followed by 1 week off the medicine. Your doctor will determine how many times you should repeat this treatment cycle.

Take the medicine at the same time each day.

Your blood pressure will need to be checked often. Your liver function will also need to be checked.

If you need surgery, tell your surgeon you currently use this medicine. Regorafenib can cause problems with wounds healing, including surgical incisions. You should stop taking this medicine at least 2 weeks before you have surgery. Carefully follow your doctor's instructions about when to stop and start taking regorafenib.

Throw away any regorafenib tablets not used within 7 weeks after opening the bottle.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking regorafenib?

Grapefruit and grapefruit juice may interact with regorafenib and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking regorafenib.

Avoid taking an herbal supplement containing St. John's wort.

What are the possible side effects of regorafenib?

• headache, confusion, change in mental status;
• vision changes;
• a seizure;
• pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet;
• heart problems --chest pain, shortness of breath, feeling like you might pass out;
• increased blood pressure --severe headache, blurred vision, pounding in your neck or ears;
• perforation (a hole or tear) in your stomach or intestines --fever, chills, severe stomach pain or swelling, nausea, vomiting, increased thirst, decreased urination;
• severe bleeding --bruising, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, or any bleeding that will not stop; or
• signs of infection --fever, sore throat, feeling short of breath, cough with or without mucus, vaginal itching or discharge, pain or burning when you urinate, or redness and swelling anywhere in your body.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• diarrhea, nausea, stomach pain;
• loss of appetite, weight loss;
• increased blood pressure;
• fever, infection;
• abnormal liver function tests;
• pain or redness in your mouth or throat, hoarse voice; or
• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect regorafenib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect regorafenib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about regorafenib.