What are some of the side effects possible with ERBITUX?

Select Serious Side Effects:

Allergic reactions

Severe allergic reactions are a serious side effect with ERBITUX. Allergic reactions are rare but may cause death. Tell your doctor or nurse right away if you have trouble breathing, are wheezing or hoarse, or have fever, chills, or a tight feeling in your airways. Symptoms can also include low blood pressure, shock, loss of consciousness, and/or heart attack. Severe allergic reactions can happen at any time during treatment, but they happen most often at the first dose. The risk of anaphylactic reactions may be increased in people with a history of tick bites, a red meat allergy, or certain specific antibodies.

Heart attack

Heart attack is a serious side effect with ERBITUX. Heart attack or sudden death has happened in some people who received ERBITUX with radiation therapy or cetuximab with platinum-based chemotherapy and fluorouracil. Heart attack can also occur as a consequence of infusion-related reactions. Tell your doctor if you have a history of heart disease.

Skin problems

Skin problems are one of the most serious side effects of ERBITUX. Skin problems include an acne-like rash, skin drying and cracking, infections, and abnormal hair growth. The skin around your fingernails and toenails may swell. Blistering of the skin or mucous membranes (such as the mouth) or peeling of the skin may be symptoms of serious reactions that could lead to death. Contact your doctor right away if you have any of these symptoms.

Possible side effects and tips to help care for them

ERBITUX may cause hair changes. Hair changes during EGFR treatment may:

  • Make the eyelashes grow very fast and become very long and bother your eyes
  • Cause fast growth to eyebrows
  • Cause hair on the scalp to become curly, fine, or brittle
  • Start a few weeks to months after starting treatment and go away after treatment is stopped.

Side effects for each person may vary. Tell your doctor or nurse if you notice hair changes or any other side effects.

ERBITUX may cause an acne-like skin rash. Acne-like skin rash during EGFR treatment may:

  • Look like acne, but it is not
  • Be red, swollen, crusty, and very dry
  • Feel itchy, tender, painful, or warm or burning (like a sunburn)
  • Happen on the scalp, face, chest, or upper back, or other parts of the body if the case is severe
  • Start and may be worse during the first few weeks of treatment
  • Get better or stay the same during treatment
  • Go away after treatment is stopped, but not always immediately
  • Become infected
  • Cause the skin to change color after the rash has gone away

Tips to help care for skin problems:

  • Talk to your doctor or nurse about management of skin problems
  • Your doctor or nurse may suggest the use of moisturizing lotion to help keep skin moist
  • They may also suggest cool compresses to relieve itching
  • Being out in the sun may make skin problems worse. People receiving ERBITUX should wear sunscreen and hats and limit sun exposure during treatment and for 2 months following the last dose of ERBITUX
  • Rash may be treated with antibiotics. Antibiotics may be in pill form (and may be taken by mouth) or as a skin cream

Side effects for each person may vary. You may experience other side effects while being treated with ERBITUX. Your treatment team is there to help, so be sure to let them know if you notice an acne-like rash or any other side effects that are bothering you.

What to do:

  • Tell your doctor if you have fatigue or weakness
  • Make a plan for each day that includes time for activity and time for rest. Try to do the most important things first, while you have energy
  • Keep a journal of how you feel each day, noting when you are tired or feeling energetic
  • Do small amounts of activity to give yourself energy
  • For persistent fatigue, talk to your doctor

What to avoid:

  • Avoid foods or drinks with caffeine, such as coffee or chocolate, in the afternoon or night
  • If you are having trouble sleeping at night, avoid late-afternoon naps

You may experience other side effects while being treated with ERBITUX. Your treatment team is there to help, so be sure to let them know about any side effects that are bothering you.

Tips to help care for diarrhea:

What to do:

  • Tell your doctor if you experience diarrhea
  • Eat many small meals, rather than 3 normal-size meals
  • Eat Bananas, white Rice, Applesauce, white Toast (the BRAT diet)
  • Drink plenty of water, clear liquids, or sports drinks

What to avoid:

  • Do not drink milk or eat milk products, such as ice cream
  • Do not eat greasy or spicy foods
  • Avoid whole wheat or whole grain foods and other foods high in fiber, such as raw vegetables, beans, and nuts

Tips to help care for nausea:

  • Tell your doctor if you have nausea
  • Eat smaller meals more often during the day
  • Eat foods that are light or bland (have a mild flavor), such as chicken noodle soup or scrambled eggs
  • Eat dry foods, such as crackers, bread, or dry cereal, when you first wake up or if your stomach is empty
  • Sip clear liquids, such as water or a sports drink, or suck on ice chips or ice pops
  • Rest a bit after eating, but avoid lying down flat for at least 1 hour after a meal
  • Rinse your mouth before and after you eat a meal

You may experience other side effects while being treated with ERBITUX. Your treatment team is there to help, so be sure to let them know about any side effects that are bothering you.

ERBITUX may cause nail changes. Nail changes during EGFR treatment may:

  • Look like swollen, red skin around the fingernails or toenails
  • Appear similar to ingrown nails or infection
  • Cause nails to form ridges or to fall off
  • Be swollen and painful
  • Appear 2 to 4 months after starting treatment
  • Last for many months after treatment

Side effects for each person may vary. Tell your doctor or nurse if you notice nail changes or any other side effects.

What should I do if I experience side effects?

Contact your doctor or treatment team. They are the best source for advice when it comes to taking care of any side effects you may have with ERBITUX.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Indications and Important Safety Information Warning: Allergic reactions and heart attack
Warning: Allergic reactions and heart attack
Indications

Head and Neck Cancer

ERBITUX® (cetuximab) is approved:

  • In combination with radiation therapy for the initial treatment of a certain type of locally or regionally advanced head and neck cancer
  • In combination with platinum-based chemotherapy and fluorouracil for the initial treatment of patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body
  • For use alone to treat patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body and whose disease has progressed following platinum-based chemotherapy

Metastatic Colorectal Cancer

ERBITUX is approved for the treatment of certain patients who have colorectal cancer that has spread to other parts of the body. Only patients whose tumors are KRAS wild-type (which means they have a KRAS mutation-negative gene), and whose tumors have a protein called epidermal growth factor receptor (EGFR), should receive ERBITUX. An FDA-approved test is used to determine if tumors have these particular traits. Treatment with ERBITUX is given in the following three ways:

  • In combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for patients who are being treated for this type of cancer for the first time
  • In combination with another chemotherapy drug, irinotecan, for patients whose disease has progressed after receiving chemotherapy with irinotecan
  • As a single agent:
    • For patients whose disease has progressed after receiving both irinotecan and oxaliplatin
    • For patients who are unable to tolerate chemotherapy with irinotecan

ERBITUX is not approved to treat colorectal cancer in patients whose tumors have mutations in genes called RAS (often called "RAS mutant"), or in patients for whom the mutational status of the genes is not known.

ERBITUX is available by prescription only.

IMPORTANT SAFETY INFORMATION FOR ERBITUX®(cetuximab)
What is the most important information I should know about ERBITUX?

WARNING: ALLERGIC REACTIONS AND HEART ATTACK

ERBITUX can cause serious and sometimes fatal allergic reactions. Serious allergic reactions due to ERBITUX therapy occurred in 2.2% of patients receiving ERBITUX during clinical studies; 1 patient died. The risk of anaphylactic reactions may be increased in patients with a history of tick bites, red meat allergy, or in the presence of certain antibodies which can react to ERBITUX.

  • Symptoms can include trouble with breathing (including tightening of the airways, wheezing, or hoarseness), low blood pressure, shock, loss of consciousness, and/or heart attack. Report these signs and symptoms of infusion reactions, as well as fever, and/or chills to your doctor or nurse.
  • Approximately 90% of the severe allergic reactions occurred with the first treatment with ERBITUX (even if the patient had been premedicated with antihistamines), although some patients experienced their first severe allergic reaction during a later treatment.
  • Your doctor or nurse should watch you closely for these symptoms during treatment and for at least 1 hour following treatment and may need to stop therapy in the event of an allergic reaction. After the allergic reaction resolves, your doctor may be able to restart therapy.
  • If you have a severe allergic reaction, treatment with ERBITUX must be stopped immediately and not started again.

ERBITUX can cause heart attack or sudden death

  • Heart attack or sudden death occurred in 2% of 208 patients with head and neck cancer treated with radiation therapy and ERBITUX in a clinical study. Three patients with a prior history of coronary artery disease died within six weeks after receiving the last dose of ERBITUX. One patient with no prior history of coronary artery disease died one day after the last dose of ERBITUX.
  • Heart problems resulting in death or sudden death occurred in 3% of 219 patients with head and neck cancer treated with ERBITUX and platinum-based chemotherapy with fluorouracil in a clinical study.
  • Notify your doctor if you have a history of any heart disease.

  • ERBITUX can cause lung disease. Lung disease occurred in less than 0.5% of 1570 patients receiving ERBITUX in clinical trials for colorectal cancer and head and neck cancer; 1 patient died.
    • Notify your doctor if you develop shortness of breath, a new or worsening cough and/or chest pain while receiving ERBITUX
    • ERBITUX treatment should be stopped if breathing symptoms worsen, and should not be restarted if lung disease is diagnosed
  • ERBITUX can cause skin problems including an acne-like rash, skin drying and cracking, infections (including infections of the blood, skin, eyes, and lips), swelling of the base of the nails or loss of the nails, inflammation of the eye or eyelid, decreased vision and abnormal hair growth. These symptoms were seen in several clinical trials for colorectal cancer and head and neck cancer with ERBITUX.
    • Sun exposure may worsen these effects. Patients taking ERBITUX should wear sunscreen and hats to limit sun exposure during treatment and for 2 months after the last dose of ERBITUX.
    • Severe reactions with symptoms of rash; blistering of the skin, mouth, eyes, and genitals; and shedding of the skin have been seen in patients treated with ERBITUX. These reactions may be life-threatening and possibly lead to death. It is not clear if these reactions are related to the way ERBITUX works or to an immune response, such as Stevens-Johnson syndrome or toxic epidermal necrolysis. Your doctor may withhold, reduce dose or discontinue ERBITUX based on the severity of these symptoms.
    • Notify your doctor if you develop any of these symptoms while receiving ERBITUX.
  • Risks when using ERBITUX with radiation and cisplatin. In a study of 940 patients with head and neck cancer, patients received either a combination of radiation and cisplatin (a cancer drug), or ERBITUX in combination with radiation and cisplatin. Adding ERBITUX resulted in an increase in occurrence of severe or life-threatening redness and sores of the lining of the mouth, lips or throat and other digestive organs; skin reactions caused by certain cancer drugs given after radiation; acne-like rash; heart problems; and blood electrolyte disturbances (compared to radiation and cisplatin alone)
    • Side effects resulting in death occurred in 4% of patients in the ERBITUX plus radiation and cisplatin treatment arm, and 3% in the radiation therapy and cisplatin alone treatment arm
    • 2% of patients in the ERBITUX plus radiation and cisplatin treatment arm experienced decreased blood flow to the heart, compared to 0.9% in the radiation therapy and cisplatin alone treatment arm
    • The main point of the study was to measure how long patients survived before their cancer got worse. Adding ERBITUX to radiation and cisplatin did not improve this measure
  • ERBITUX when given by itself and in combination with other cancer drugs can cause low levels of magnesium, calcium and potassium.
    • Your doctor or nurse should periodically monitor your blood electrolyte levels during and for at least 8 weeks after treatment with ERBITUX, and administer intravenous replacement as needed
  • If you have colorectal cancer with mutations in the Ras genes, you should not be treated with ERBITUX because you will not benefit from ERBITUX treatment and will experience side effects.
  • ERBITUX can harm your unborn baby. If you are able to become pregnant, you should use effective contraception during treatment with ERBITUX and for 2 months after the last dose of ERBITUX.
What are the most common side effects of ERBITUX?
  • The most common side effects (all grades of severity) reported in patients with head and neck cancer treated with ERBITUX in combination with radiation therapy versus radiation therapy alone (incidence ≥25%) were: feeling weak, fever, nausea, vomiting, weight loss, dehydration, elevated liver enzymes in blood tests, sore throat, acne-like rash, and skin irritation in the radiation area. In areas treated with radiation therapy, the addition of ERBITUX to the radiation therapy increases the risk of damage to surrounding healthy tissues in the area treated with radiation. The most common serious side effects (incidence ≥10%) reported by patients included skin irritation in the radiation area, acne-like rash, and weight loss.
  • The most common side effects (all grades of severity) in patients with head and neck cancer treated with the European version of ERBITUX in combination with platinum-based chemotherapy with fluorouracil versus chemotherapy alone (incidence ≥25%) were: acne-like rash, nausea, infection, rash, diarrhea and anorexia, a psychological disorder characterized by a loss of appetite. Most common serious side effects (incidence ≥10%) reported by patients in either arm was: infection. ERBITUX results in approximately 22% higher blood levels of cetuximab as compared to the European version of ERBITUX. It is possible that U.S. patients receiving ERBITUX may experience more frequent or severe side effects than patients in the study conducted in Europe.
  • The most common side effects (all grades of severity) in patients with Epidermal Growth Factor Receptor (EGFR) positive, KRAS wild-type colorectal cancer that has spread to other parts of the body who were treated with the European version of ERBITUX in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) versus FOLFIRI alone (incidence ≥25%) were: abnormal decrease in certain white blood cell counts, diarrhea, sore mouth, fever, anorexia, a psychological disorder characterized by a loss of appetite and rash which includes a rash including acne-like rash. Most common serious side effects (incidence ≥10%) reported by patients in either arm were: abnormal decrease in certain white blood cell counts, acne-like rash, and diarrhea. In this study, the type and severity of side effects seen with European cetuximab were similar to other studies of U.S. patients receiving ERBITUX for metastatic colorectal cancer.
  • The most common side effects (all grades of severity) in patients with Epidermal Growth Factor Receptor (EGFR) positive, KRAS wild-type colorectal cancer that has spread to other parts of the body who were treated with ERBITUX and supportive care versus supportive care alone (incidence ≥25%) were: rash including shedding of the outer layer of the skin, dry skin, itchy skin, other skin problems, nail changes, feeling tired, fever, other pain, headache, shortness of breath, cough, nausea, constipation, diarrhea, vomiting, sore mouth, infection without decrease in certain white blood cell counts, sensory neuropathy (weakness, numbness and pain from nerve damage usually in the hands and feet) and problems sleeping. Most common serious side effects (incidence ≥10%) reported by patients included: feeling tired, other pain, rash including shedding of the outer layer of the skin, shortness of breath, other intestinal problems and infection without abnormal decrease in certain white blood cell counts.
  • The most common side effects (all grades of severity) in patients with colorectal cancer that has spread to other parts of the body whose tumors had a protein called Epidermal Growth Factor Receptor (EGFR) treated with ERBITUX and irinotecan were: acne-like rash, feeling weakness or discomfort, diarrhea, and nausea. The most common serious side effects reported included: diarrhea, decrease in white blood cell count, feeling weakness or discomfort, and acne-like rash.

You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
What should I tell my doctor before starting treatment with ERBITUX?
Before you start treatment with ERBITUX, tell your doctor:
  • If you have any history of heart disease or a heart condition.
  • If you have a history of breathing problems or other lung problems.
  • If you are pregnant or if you plan on becoming pregnant. Because ERBITUX can harm an unborn baby, you should use contraception and not become pregnant during treatment with ERBITUX and for at least 2 months after your last dose of ERBITUX. If you become pregnant during your treatment or within 2 months after your last dose, discuss this with your doctor.
  • If you are breastfeeding or plan to breastfeed. ERBITUX may be passed through human breast milk. Because of the potential for serious side effects in nursing infants from ERBITUX, you should not breastfeed during ERBITUX therapy and for 2 months after the last dose of ERBITUX.

Tell your doctor about all the medications you are taking, including prescription and over-the-counter medications.

ERBITUX is available by prescription only.
Please see full Prescribing Information for ERBITUX, including Boxed Warnings for allergic reactions and heart attack.

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