regorafenib

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Pronunciation: RE goe RAF e nib

Brand: Stivarga

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

You should not use regorafenib if past use has caused severe bleeding or severe liver problems.

Regorafenib can harm your liver. Stop taking this medicine and call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

What is regorafenib?

Regorafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Regorafenib is used to treat colorectal 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?

You should not use regorafenib if past use has caused severe bleeding or severe liver problems.

To make sure regorafenib is safe for you, tell your doctor if you have:

  • liver disease;
  • heart disease, high blood pressure;
  • bleeding or blood clotting disorder such as hemophilia;
  • a history of recent heart attack or stroke (including "mini-stroke"); or
  • if you have recently had surgery.

Do not use regorafenib if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are receiving regorafenib, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either parent is taking regorafenib. Keep using birth control for at least 2 months after your treatment ends.

It is not known whether regorafenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take regorafenib?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

Regorafenib works best if you take it after a low-fat meal. Swallow the tablet whole with a full glass of water.

Take the medicine at the same time each day.

While using regorafenib, your blood pressure will need to be checked often. You may also need frequent blood tests at your doctor's office.

If you need surgery, tell the surgeon ahead of time that you are using regorafenib. You may need to stop using the medicine at least 2 weeks before your surgery. Follow your doctor's instructions.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Do not put regorafenib tablets into a daily pill box.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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 at the same time you are taking regorafenib.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of regorafenib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using regorafenib and call your doctor at once if you have:

  • headache, confusion, change in mental status, vision loss, seizure (convulsions);
  • chest pain and severe dizziness, fainting, feeling short of breath;
  • a high fever with severe stomach pain or swelling;
  • rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
  • severe bleeding --heavy menstrual periods or abnormal vaginal bleeding, blood in your urine or stools, coughing up blood, or any bleeding that will not stop;
  • signs of infection --fever, chills, flu symptoms, mouth sores, severe or ongoing vomiting or diarrhea;
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • dehydration symptoms --feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • dangerously high blood pressure --blurred vision, buzzing in your ears, anxiety, uneven heartbeats; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, diarrhea, stomach pain, loss of appetite, weight loss;
  • infection;
  • mouth or throat pain, 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?

Many drugs can interact with regorafenib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with regorafenib. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about regorafenib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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