(re goe RAF e nib)
Trade name: Stivarga®
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:
- 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
- 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
- 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.
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 :
These side effects are less common side effects (occurring in about 10-29%) of patients
receiving regorafenib :
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.
Not all side effects are listed above. Some that are rare (occurring in less than
10% of patients) are not listed here. However, you should always inform your health
care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider or emergency room:
Contact your health care provider immediately, day or night, if you
should experience any of the following symptoms:
- Fever of 100.4° F (38° or higher, chills)
- Signs of a very bad reaction (wheezing, chest tightness, fever, itching, bad cough,
blue or grey skin color, seizures, or swelling or the face, lips, tongue or throat).
- Sudden change in eyesight, fast heartbeat, very bad headache, very bad dizziness
or passing out.
Always inform your health care provider if you experience any unusual symptoms.
The following symptoms require medical attention, but are not an emergency.
Contact your health care provider within 24 hours of noticing any of the
- Diarrhea (4-6 episodes in a 24-hour period).
- Nausea (interferes with ability to eat and unrelieved with prescribed medication).
- Vomiting (vomiting more than 4-5 times in a 24 hour period).
- Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst,
dry mouth, dark and decrease amount of urine, or dizziness.
- Skin or the whites of your eyes turn yellow
- Urine turns dark or brown (tea color)
- Decreased appetite
- Pain on the right side of your stomach
- Bleed or bruise more easily than normal
- Skin changes (rash, acne, itching, blisters, peeling, redness or swelling)
- Increase in blood pressure
- Feeling very tired or weak (unable to carry on self-care activities)
- Big weight gain or loss
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Signs of infection (very bad sore throat, ear or sinus pain, cough, more sputum
or change in color of sputum, pain with passing urine, mouth sores, wound that will
not heal or anal itching or pain).
Always inform your health care provider if you experience any unusual symptoms.
- Before starting regorafenib treatment, make sure you tell your doctor about any
other medications you are taking (including prescription, over-the-counter, vitamins,
herbal remedies, etc.). Do not take anything new without discussing with your provider
first. This is very important as other medications, etc. may interact with regorafenib.
- Do not receive any kind of immunization or vaccination without your doctor's approval
while taking regorafenib.
- Inform your health care professional if you are pregnant or may be pregnant prior
to starting this treatment. Pregnancy category D (regorafenib may be hazardous to
the fetus. Women who are pregnant or become pregnant must be advised of the potential
hazard to the fetus.)
- For both men and women: Do not conceive a child (get pregnant) while taking regorafenib.
Barrier methods of contraception, such as condoms, are recommended during therapy
and for at least 2 months following treatment. Discuss with your doctor when you
may safely become pregnant or conceive a child after therapy.
- Do not breast feed while taking this medication.
- You should not drink grapefruit juice or eat grapefruit during your treatment with
regorafenib. It may make the amount of regorafenib in your blood increase to a harmful
- If you are taking a blood thinner, have your blood levels checked as prescribed.
- Have your blood pressure checked often.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed
- You may be at risk of infection so try to avoid crowds or people with colds, and
report fever or any other signs of infection immediately to your healthcare provider.
- Wash your hands often.
- Ask your doctor or nurse before scheduling dental appointments or procedures.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- If you should experience nausea, take anti-nausea medications as prescribed by your
doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also
- Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
- In general, drinking alcoholic beverages should be avoided completely. You should
discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Keep your mouth clean with baking soda and salt rinses. You can mix 1/2 to 1 tsp.
of baking soda and/or 1/2 to 1 tsp. salt in 8 ounces of water, and use as a mouthwash,
to avoid or decrease the severity of mouth sores.
- Regorafenib can cause tiredness, weakness or blurred vision. If you have any of
these symptoms, use caution when driving a car, using machinery, or anything that
requires you to be alert.
- If you experience symptoms or side effects, be sure to discuss them with your health
care team. They can prescribe medications and/or offer other suggestions that are
effective in managing such problems.
Monitoring and testing:
You will be checked regularly by your health care professional while you are taking
regorafenib. Testing may include: electrolytes, complete blood counts, liver function
test, and blood pressure to monitor side effects and check your response to therapy.
If you are on warfarin (Coumadin) your blood INR may be monitored more frequently.
How this drug works:
Targeted therapy is the result of about 100 years of research dedicated to understanding
the differences between cancer cells and normal cells. To date, cancer treatment
has focused primarily on killing rapidly dividing cells because one feature of cancer
cells is that they divide rapidly. Unfortunately, some of our normal cells divide
rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists
look for specific differences in the cancer cells and the normal cells. This information
is used to create a targeted therapy to attack the cancer cells without damaging
the normal cells, thus leading to fewer side effects. Each type of targeted therapy
works a little bit differently but all interfere with the ability of the cancer
cell to grow, divide, repair and/or communicate with other cells.
There are different types of targeted therapies, defined in three broad categories.
Some targeted therapies focus on the internal components and function of the cancer
cell. The targeted therapies use small molecules that can get into the cell and
disrupt the function of the cells, causing them to die. There are several types
of targeted therapy that focus on the inner parts of the cells. Other targeted therapies
target receptors that are on the outside of the cell. Therapies that target receptors
are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the
blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.
Regorafenib is a targeted therapy that targets and binds to tyrosine kinase receptors
and inhibits epidermal growth factor receptor (EGFR) and vascular endothelial growth
factor (VEGF), receptors on the surface of the cell. By binding to these receptors
regorafenib blocks an important pathway that promotes cell division.
Research continues to identify which cancers may be best treated with targeted therapies
and to identify additional targets for more types of cancer.
Note: We strongly encourage you to talk with your health care professional
about your specific medical condition and treatments. The information contained
in this website is meant to be helpful and educational, but is not a substitute
for medical advice.