Chemo Experts, the easiest way to learn about cancer treatment
Find a Treatment:
Cancer Types
or
Treatments

Treatment Name: Regorafenib (Stivarga®)

Regorafenib (Stivarga®) is a Chemotherapy Regimen for Colon Cancer

How does regorafenib work?
Regorafenib is a chemotherapy drug that is a small molecule called a Tyrosine Kinase Inhibitor (TKI) that turns off several proteins that are not functioning properly which help cancer cells to grow and survive.

Goals of therapy:
Regorafenib is taken to shrink tumors and decrease symptoms of colon cancer and is not commonly given with the goal of cure.

Schedule

Create your own Treatment Tracker

  • Usual starting dose: 160 mg (four 40 mg tablets) by mouth once daily for 21 consecutive days followed by 7 days off
    • It is best to take each dose after eating a low-fat meal (containing less than 600 calories and less than 30% fat)

Regorafenib must be dispensed by a specialty pharmacy and is taken at home. Treatment is continued until the drug no longer works or until unacceptable side effects occur.

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

Side Effects

In clinical studies, the most commonly reported side effects of regorafenib (Stivarga®) are shown here:

  • Fatigue (47%)
  • Redness and blisters on palms of hands and soles of feet (47%)
  • Diarrhea (34%)
  • Decreased appetite (30%)
  • Voice changes (29%)
  • High blood pressure (28%)
  • Mouth sores (27%)
  • Skin rash or peeling (26%)
  • Nausea (14%)
  • Weight loss (14%)
  • Thrombocytopenia [low platelets] (13%)
  • Fever (10%)
  • High blood bilirubin [sign of liver injury] (9%)
  • Constipation (8%)
  • Dry skin (8%)
  • Vomiting (8%)
  • Hair loss (7%)
  • Changes in taste (7%)
  • Nerve pain (7%)
  • Nose bleed (7%)
  • Anemia [low red blood cells] (7%)
  • Shortness of breath (6%)
  • Muscle pain (6%)
  • Headache (5%)
  • Stomach pain (5%)
  • Low blood phosphorous (5%)

On average, 8% of patients discontinue drug treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
Fatigue Fatigue DiarrheaDiarrheaNausea and VomitingNausea and VomitingConstipationConstipationHair LossHair LossPainPainBleedingBleedingAnemiaAnemia

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, every two weeks for the first two months of treatment, then monthly thereafter. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order. Blood pressure is typically checked weekly for the first six weeks of treatment, and then monthly thereafter. CEA (carcinoembryonic antigen), a tumor marker, may be checked periodically.

How often is imaging needed?
Imaging may be checked before treatment then approximately every 8 weeks. Imaging may also be checked if you have any signs or symptoms of a serious side effect. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue regorafenib as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Contact your doctor immediately if you experience severe abdominal pain or yellowing of the skin or eyes as these may be signs of severe liver injury
  • If you have high blood pressure that is not well controlled, you may need to take additional medications or have your current medications adjusted before starting regorafenib
  • Go to the nearest emergency room if you experience chest pain, shortness of breath, or feel dizzy and lightheaded as these may be signs of a serious heart problem
  • Let your doctor know when you are going to have any surgeries or procedures as regorafenib may need to be stopped for at least two weeks prior to the surgery or procedure
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for colon cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Regorafenib (Stivarga®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Regorafenib (Stivarga®). Depending upon your income, they may be able to help cover the cost of:

  • Regorafenib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Regorafenib (Stivarga®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Regorafenib (Stivarga®)

Individual Drug Label Information

Regorafenib (Stivarga®)

  • ​Is an oral tablet available in 40 mg
  • Regorafenib has been issued a FDA Black Box Warning for severe liver toxicity
  • Is taken with a glass of water after eating a low-fat meal (containing less than 600 calories and less than 30% fat). Swallow tablets whole and take at the same time each day
  • Food increases absorption so it is best to take after a low-fat meal to avoid a possible decrease in effectiveness. Be careful to not take with a high fat meal as this may cause too much medication to be absorbed and could cause an increase in side effects
  • If you miss a dose, take the dose as soon as you remember if it is the same day. If you don’t remember until the next day, skip the missed dose and take your dose at the regularly scheduled time. Do not double your dose to make up for the missed dose
  • Should be stored at 25°C (77°F). Short periods of exposure to temperatures from 15 to 30°C (59 to 86°F) are acceptable. Store in original container and do not place in a pillbox or pill organizer. Discard any tablets that may be remaining seven weeks after opening a pill bottle
  • Dosage adjustments may be required for serious or unacceptable side effects
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions 
  • May interact with grapefruit and grapefruit juice causing increased blood levels of regorafenib. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment
  • May cause fetal harm if taken while pregnant. Females should use effective contraception during treatment and for at least 2 months after the last dose. Males with female partners of reproductive potential should use effective contraception during treatment and for at least 2 months after the last dose 
  • Do not breastfeed during treatment and for at least 2 weeks after the last dose
General side effects from regorafenib
  • Liver injury
  • Infections
  • Bleeding
  • Tear in the wall of the intestines
  • Skin rash or blisters
  • High blood pressure
  • Fatigue
  • Diarrhea
  • Decreased appetite and weight loss
  • Voice changes
  • Mouth sores
  • Nausea
  • Click on the regorafenib (Stivarga®) package insert below for reported side effects, possible drug interactions, and other regorafenib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

Share this page:

References

1) Grothey A,  Van Cutsem E,  Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet.  2013;381:303-312.

Created: August 28, 2019 Updated: August 28, 2019

What is Colon Cancer?

A disease of the cells from the large intestine.  Colon cancer is the third most common cancer among both men and women.  Known causes include:  family history, poor diet, sedentary lifestyle, obestity, diabetes, history of colon polyps, smoking, heavy alcohol use, prior radiation treatment to abdomen for other cancers, and old age.  The stage can vary at diagnosis and throughout treatment.  Stages of colon cancer use Tumor, Node, Metastasis (TNM) staging as well as Stage Grouping using Stages I, II, III, or IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common starting doses for Regorafenib (Stivarga®)

  • Usual starting dose: 160 mg (four 40 mg tablets) by mouth once daily for 21 consecutive days followed by 7 days off

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is Specialty Pharmacy?

A pharmacy that manages the handling and services for drugs used by patients with rare or chronic diseases. This has expanded in the last several years to include very expensive drugs used to treat cancer, mainly oral cancer medications or injections that can be taken at home.