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Treatment Name: FOLFIRI + Cetuximab (Erbitux®)

FOLFIRI + Cetuximab (Erbitux®) is a Chemotherapy Regimen for Colon Cancer

How does FOLFIRI + cetuximab work?
Each of the chemotherapy drugs in FOLFIRI are designed to kill cancer cells. Cetuximab (an immunotherapy drug) is designed to bind to the surface of cancer cells and shut down one of the signals that tell the colon cancer cells to grow.

FOL – folinic acid (leucovorin)
F – fluorouracil (5-FU)
IRI –irinotecan (Camptosar®)
+
Cetuximab (Erbitux®)

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

Schedule

  • Folinic acid (Leucovorin) intravenous infusion (I.V.) over two hours before fluorouracil on Day 1
  • Fluorouracil (5-FU) I.V. push given over 3 to 5 minutes on Day 1
  • Irinotecan I.V. infusion given over 90 minutes on Day 1
  • Fluorouracil (5-FU) continuous I.V. infusion via home-infusion pump over 46 hours beginning Day 1 and ending on Day 3
  • Cetuximab I.V. given over two hours on Day 1 of Cycle 1, then over one hour every week starting weekly after the first dose

Estimated total infusion time for this treatment:

  • Up to 6 hours for Cycle 1, Day 1, when all medications are given on the same day. If the first treatment is tolerated well, infusion time can be as short as 5 hours for the first day of the next cycles
  • On days when just cetuximab is given, infusion time can take as little as two hours
  • Some doctors may choose to give cetuximab every two weeks, with the FOLFIRI part of the treatment, instead of weekly. This requires doubling the cetuximab dose. This may be chosen to decrease infusion center visits to just every two weeks
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

FOLFIRI + cetuximab is usually given in an outpatient infusion center, allowing the person to go home with an infusion pump, and then return to the infusion center in two days to get the pump disconnected. On occasion, FOLFIRI + cetuximab may be given in the hospital if someone is too sick.

FOLFIRI + cetuximab is repeated every 14 days. This is known as one Cycle. Each cycle may be repeated until the regimen no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Click here for the common FOLFIRI + cetuximab starting doses.

Side Effects

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most serious drug side effects reported from FOLFIRI + cetuximab are shown here:

  • Neutropenia [low white blood cells] (28%)
  • All skin reactions (20%)
  • Acne-like skin rash (16%)
  • Diarrhea (16%)
  • Fatigue (5%)
  • Vomiting (5%)
  • Infusion reaction (3%)

On average, 9% of patients discontinue treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue Neutropenic FeverNeutropenic FeverNausea and VomitingNausea and VomitingPainPain

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood magnesium, blood potassium, plus any others your doctor may order. CEA (carcinoembryonic antigen), a tumor marker, may be checked periodically.

How often is imaging needed?
Imaging may be checked before treatment and periodically during treatment. Imaging may include: 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 FOLFIRI + cetuximab 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

  • Colorectal cancer patients will have an infusion pump strapped to their body for 2 days to allow fluorouracil (5-FU) to continuously infuse into a vein. The I.V. pump is connected at the end of the chemotherapy session by a nurse. When the infusion is finished (two days later) the patient will have to go back to the infusion center or hospital to have it disconnected, unless a home health nurse comes to the patient’s home to do this
  • Diarrhea caused by irinotecan is commonly treated with atropine injections in the medical setting, both before and after the infusion. Diarrhea at home can affect quality of life and is commonly treated with loperamide (Imodium) purchased over-the-counter at a pharmacy. You may receive special instructions on how to use loperamide for diarrhea caused by irinotecan. Tell your doctor immediately of you have severe diarrhea at home or go to an emergency department immediately
  • The first dose of cetuximab is the dose most likely to cause an infusion reaction, which may include: fever, shaking, chills, and shortness of breath; the incidence of this is very low, 2% or less. Even if medications (pre-meds) are given beforehand this can happen. Side effects generally go away when the infusion is stopped. It may be restarted at a slower rate. Most patients are able to receive the entire dose, although it may take longer than expected
  • Development of a skin rash is common while on cetuximab however, development of skin rashes may be linked with better disease response from this drug. Mild skin rashes can be treated with topical or oral antibiotics that are prescribed by your doctor. More severe rashes may be able to be treated with oral medications. Tell your doctor about any skin reactions
  • Avoid excess sun exposure while receiving cetuximab and up to 2 months after the last dose
  • Before each infusion, you may receive an antihistamine such as diphenhydramine (Benadryl®) to help prevent reactions. If possible, have someone drive you to and from these appointments as diphenhydramine can make you sleepy and have difficulty driving
  • Cetuximab may cause changes to fingernails and toenails such as redness, swelling, oozing, bleeding, cracking, discoloration, or ridges in the nails. This is known as “paronychia”. This can first develop weeks or months after starting therapy with cetuximab and can last for months after therapy is stopped. To help prevent paronychia from developing, avoid wearing tight fitting shoes or gloves and avoid putting unnecessary pressure or friction on fingernails and toenails. If you experience symptoms of paronychia, talk with your doctor as prescription corticosteroid creams or antibiotics may be needed
  • Cetuximab may decrease your blood levels of potassium and/or magnesium. You may need to receive fluids into the vein containing magnesium and potassium. These infusions can increase your time at the infusion center by one to four hours depending on the dose
  • 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 colon cancer 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 FOLFIRI + Cetuximab (Erbitux®), 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 FOLFIRI + Cetuximab (Erbitux®). Depending upon your income, they may be able to help cover the cost of:

  • Folinic acid
  • Fluorouracil
  • Irino­tecan
  • Cetuximab

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 FOLFIRI + Cetuximab (Erbitux®) 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 FOLFIRI + Cetuximab (Erbitux®)

Individual Drug Label Information

Folinic acid (Leucovorin)

  • Folinic acid is an intravenous (I.V.) drug that is a derivative of folic acid, also known as vitamin B9
  • Is clear to slightly yellow in color
General Folinic Acid (Leucovorin) Side Effects
  • Seizures and fainting have been rarely reported
  • Click on the Folinic Acid (Leucovorin) package insert for all reported side effects and possible drug interactions
See DailyMed package insert.

Fluorouracil (Adrucil®)

  • Fluorouracil (5-FU) Is an intravenous (I.V.) drug
  • Recommended to be given only under the supervision of a qualified physician well versed in administering chemotherapy
General Fluorouracil (5-FU, Adrucil) Side Effects
  • Low white blood cell count (leucopenia and neutropenia)
  • Mouth and throat sores or ulcers (mucositis)
  • Diarrhea
  • Nausea and vomiting
  • Low red blood cell and platelet counts
  • Allergic reactions, rarely
  • Eye pain, light sensitivity, excess watering, visual changes
  • Headache
  • Skin conditions:  dryness, redness, tingling, light sensitivity, pain, swelling, loss of nails (hand-foot syndrome)
  • Dosage adjustments may be required for severe liver dysfunction
  • Click on the Fluorouracil (5-FU, Adrucil) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPainNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Irino­tecan (Camp­tosar®)

  • Irinotecan is an intravenous (I.V.) drug
  • Recommended to be given only under the supervision of a qualified physician well versed in administering chemotherapy
  • Can induce two forms of diarrhea: early and late. Late usually occurs 24 hours after finishing an irinotecan infusion.  Late diarrhea can be life threatening and should be quickly reported to your physician or visit an emergency department immediately
  • Severe low white blood count may occur, which can lead to infections
  • Dosage adjustments may be required for patients experiencing severe diarrhea, liver dysfunction, or patients with very low white blood cell counts (neutropenia)
  • Irinotecan can interact with ketoconazole and St. John’s Wort.  Those medications should be stopped 2 weeks before starting irinotecan therapy
  • There are known drug interactions of irinotecan with CYP3A4 inducers:  phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, and atazanavir
General Irinotecan (Camptosar) Side Effects
  • Diarrhea
  • Nausea
  • Vomiting
  • Low white blood cell count (neutropenia)
  • Fevers from low white blood cell count (neutropenic fever)
  • Mouth sores and inflammation (mucositis)
  • Inflammation of the large intestine (colitis)
  • Kidney impairment or kidney failure has rare reports
  • Blockage of blood vessels by a clot (thromboembolism)
  • Lung toxicities, such as shortness of breath or cough
  • Avoid during pregnancy, known to cause fetal harm
  • Click on the irinotecan (Camptosar) package insert link below for a complete list of reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue PainPainNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

See DailyMed package insert.

Cetuximab (Erbitux®)

  • Cetuximab is an intravenous infusion given over one to two hours
  • Severe infusion reactions such as difficulty breathing, low blood pressure, and heart problems can occur. You will receive medications before each dose of cetuximab to lower your risk of experiencing these reactions
  • Heart attack (cardiac arrest) can occur due to blood electrolyte abnormalities.  Your blood electrolytes (potassium, magnesium, and calcium) will usually be checked before each dose of cetuximab
  • Dosage adjustments may be required for serious skin reactions or other toxicities
  • Cetuximab does not have any drug interactions, but it does boost the effect of platinum drugs and radiation therapy
General Cetuximab (Erbitux) Side Effects
  • Skin reactions, acne-like rash and dry skin
  • Mouth sores
  • Difficult swallowing, painful swallowing
  • Dry mouth
  • Throat pain
  • Shortness of breath
  • Weight loss
  • Dehydration
  • Nausea 
  • Infection
  • Weakness and fatigue
  • Decrease in blood magnesium, potassium, or calcium levels
  • Diarrhea
  • Headache
  • Click on the cetuximab (Erbitux) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPain

See DailyMed package insert.

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References

Van Cutsem E, Köhne CH, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009;360(14):1408-17.

Created: August 29, 2018 Updated: August 29, 2018

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.

​What is Leucovorin?

Leucovorin is not a chemotherapy agent. It is a special form of folic acid that helps decrease side effects from methotrexate. Doses may be increased during therapy depending on the amount of methotrexate in the blood. Folic acid should NOT be confused with leucovorin (folinic acid) as it does not work the same way.

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

Common Starting Doses

  • Folinic acid (Leucovorin) 400 mg/m2 intravenous infusion (I.V.) over 2 hours (before fluorouracil I.V. push) on Day 1
  • Fluorouracil 400 mg/m2 I.V. push, over 3 to 5 minutes on Day 1
  • Irinotecan 180 mg/m2 I.V. infusion, over ninety minutes on Day 1
  • Fluorouracil 2400 mg/m2 continuous I.V. infusion via home-infusion pump over 46 hours beginning Day 1 and ending on Day 3
  • Cetuximab 400 mg/m2 I.V. over two hours on Day 1 of Cycle 1, then Cetuximab 250 mg/m2 over one hour, once weekly, thereafter

Alternative cetuximab schedule:  

  • 500 mg/m2 over one to two hours every 2 weeks. Maximum rate is 10 mg/minute

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