Regorafenib (re-goe-RAF-e-nib)

Treats cancer, including colon, rectal, liver, and gastrointestinal cancer.

Brand Name(s):

Stivarga

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take the tablet at the same time each day with a low-fat meal (less than 30% fat) that is less than 600 calories.
• Swallow the tablet whole with water. Do not crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the tablets at room temperature, in the original container. Do not place the tablets in daily or weekly pill boxes. Keep the medicine away from heat, moisture, and direct light. Throw away any unused medicine 7 weeks after you first open the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how regorafenib works. Tell your doctor if you are using any of the following:
  • Atorvastatin, carbamazepine, clarithromycin, fluvastatin, itraconazole, ketoconazole, methotrexate, nefazodone, phenobarbital, phenytoin, posaconazole, rifampin, St John's wort, telithromycin, or voriconazole
  • Blood thinner (including warfarin)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment and for at least 2 months after treatment ends.
• Tell your doctor if you have liver disease, bleeding problems, heart disease, or high blood pressure.
• Do not breastfeed while you are using this medicine and for at least 2 weeks after your last dose.
• This medicine may cause the following problems:
  • Liver problems
  • Increased risk of infections
  • Increased risk of bleeding
  • Serious skin reactions
  • Increased risk of heart attack, high blood pressure
  • Reversible posterior leukoencephalopathy syndrome (brain disorder)
  • Gastrointestinal perforation (tear in your stomach or bowels)
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may cause slow wound healing. You may need to stop taking it at least 2 weeks before and after you have surgery.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Red or dark brown urine, bloody or black stools, unexplained nosebleeds, vomit that looks like coffee grounds
• Severe rash, or redness, pain, or skin peeling on your palms or soles of your feet
• Sudden or severe headache, confusion, seizure, vision problems
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, mild nausea or vomiting, decreased appetite, weight loss
• Hair loss
• Swelling or pain in your mouth, voice changes
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088