Regorafenib is the generic name for the trade name chemotherapy drug Stivarga®. In some cases, health care professionals may use the trade name Stivarga® when referring to the generic drug name regorafenib.

Drug type : Regorafenib is a targeted therapy. It is an oral receptor tyrosine kinase inhibitor - (For more detail, see "How this drug works," below.)

What this drug is used for :
  • For the treatment of colorectal cancer.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How this drug is given :
  • Regorafenib is a pill, taken by mouth, once daily. Take with a low-fat (less than 30% fat) breakfast. Examples of a low-fat breakfast include:
    1. 2 slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly, and 8 ounces of skim milk (319 calories and 8.2 grams of fat), or
    2. 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jelly, apple juice, and 1 cup of coffee or tea (520 calories and 2 grams of fat).
  • Take regorafenib exactly as prescribed.
  • Take regorafenib at the same time every day.
  • Swallow regorafenib tablets whole. Do not crush or dissolve.
  • Do not change your dose or stop regorafenib unless your health care provider tells you to.
  • If you miss a dose, take it as soon as you remember. If it is too close to your next dose (within 12 hours), just take your next dose at your regular time.
  • Do not take more than 1 dose of regorafenib at one time. Call your health care provider right away if you take too much.
  • The amount of regorafenib that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side effects :
Important things to remember about the side effects of regorafenib :
  • Most people do not experience all of the side effects listed.
  • Side effects are often predictable in terms of their onset and duration.
  • Side effects are almost always reversible and will go away after treatment is complete.
  • There are many options to help minimize or prevent side effects.
  • There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking regorafenib :
  • Anemia
  • Increased liver enzymes (AST, ALT)
  • Fatigue
  • Protein in the urine
  • Low calcium
  • Low phosphorous
  • Low white blood cells
  • Decreased appetite
  • Increased enzymes produced by the pancreas (lipase & amylase)
  • High bilirubin in the blood
  • Hand-foot syndrome (redness, swelling, pain, skin changes on the palms and feet)
  • Diarrhea
  • Low platelets
  • Mouth sores/inflammation
  • Weight loss
  • Infection
  • High blood pressure
  • Voice disorder (Dysphonia)
  • Low sodium
  • Nausea

These side effects are less common side effects (occurring in about 10-29%) of patients receiving regorafenib :
  • Pain
  • Fever
  • Rash
  • Low potassium
  • INR increased (decreased blood clotting)
  • Increased bleeding
  • Headache
  • Alopecia

A serious, but very uncommon side effect of regorafenib is liver problems. Sometimes medications are not safe when you take them with certain other medications. Taking them together may cause bad side effects. This is one of those medications. Be sure to discuss with your provider about all the medications you take and do not start anything new without prior approval. This includes those that are over the counter and herbal as well.