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ERBITUX® (cetuximab)

ERBITUX® (cetuximab) is indicated for the treatment of patients who have colorectal cancer that has spread to other parts of the body and whose tumor expresses a protein called an Epidermal Growth Factor Receptor (EGFR). Treatment with ERBITUX is given in the following two ways:

  • 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
  • In combination with another chemotherapy drug, irinotecan, for patients whose disease has progressed after receiving chemotherapy with irinotecan. The effectiveness of ERBITUX in this combination is based on data regarding patients in clinical studies whose tumors became smaller. At present, there is no proof in this setting that ERBITUX improves the symptoms that a patient feels or helps a patient live longer

The results of certain clinical trials of patients with advanced or metastatic colorectal cancer were reviewed. It was found that ERBITUX did not work in patients whose tumors had mutations of the K-ras gene. ERBITUX is not recommended for the treatment of patients whose colorectal cancer tumors have mutations of the K-ras gene.

ERBITUX is available by prescription only.

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Possible serious side effects while taking ERBITUX include allergic reactions

Treatment with ERBITUX may cause side effects, including severe allergic reactions. The 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 a tight feeling in your airways. Symptoms of an allergic reaction also include low blood pressure, shock, loss of consciousness, and heart attack. Most of the severe allergic reactions happened with the first dose of ERBITUX. Some people had a severe allergic reaction when receiving a later dose of ERBITUX. Your doctor or nurse should watch you closely while you are receiving ERBITUX. He or she may need to stop giving you ERBITUX if you have an allergic reaction.


Indications and Important Safety Information including Boxed WARNINGS

Indications

Colorectal Cancer:

ERBITUX® (cetuximab) is indicated for the treatment of patients who have colorectal cancer that has spread to other parts of the body and whose tumor expresses a protein called an Epidermal Growth Factor Receptor (EGFR). Treatment with ERBITUX is given in the following two ways:

  • 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
  • In combination with another chemotherapy drug, irinotecan, for patients whose disease has progressed after receiving chemotherapy with irinotecan. The effectiveness of ERBITUX in this combination is based on data regarding patients in clinical studies whose tumors became smaller. At present, there is no proof in this setting that ERBITUX improves the symptoms that a patient feels or helps a patient live longer

The results of certain clinical trials of patients with advanced or metastatic colorectal cancer were reviewed. It was found that ERBITUX did not work in patients whose tumors had mutations of the K-ras gene. ERBITUX is not recommended for the treatment of patients whose colorectal cancer tumors have mutations of the K-ras gene.

ERBITUX is available by prescription only.

Important Safety Information including Boxed WARNINGS

Allergic Reaction

  • Severe allergic reactions due to ERBITUX® (cetuximab) therapy have occurred in 42 of 1373 patients (3%) receiving ERBITUX during clinical studies, resulting in death in less than 1 in 1000 patients
    • 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
    • Most (90%) of the severe allergic reactions occurred with the first dose of ERBITUX, although some patients experienced their first severe allergic reaction during a subsequent dose of ERBITUX
    • Your doctor or nurse should watch you closely for these symptoms during treatment and may need to stop therapy in the event of an allergic reaction
    • Severe allergic reactions require that treatment with ERBITUX be stopped immediately and not started again

Lung Disease

  • Lung disease, which resulted in 1 death, occurred in 4 of 1570 patients (<0.5%) receiving ERBITUX in several clinical trials in colorectal cancer and head and neck cancer
    • Notify your doctor if you develop shortness of breath while receiving ERBITUX
    • ERBITUX treatment should be stopped if symptoms worsen or lung disease is confirmed

Skin Problems

  • In several clinical trials in colorectal cancer and head and neck cancer with ERBITUX, skin problems including an acne-like rash, skin drying and cracking, infections (including infections of the blood, skin, eyes, and lips), and abnormal hair growth were seen
    • Sun exposure may worsen these effects
    • Patients taking ERBITUX should wear sunscreen and hats to limit sun exposure
    • A related nail disorder that causes painful swelling of the skin around the nails—most often of the large toes and thumbs—also was reported
    • Notify your doctor if you develop any of these symptoms while receiving ERBITUX

Electrolyte Depletion

  • Low levels of magnesium and accompanying low calcium and potassium levels have been reported with ERBITUX when given by itself and in combination with other cancer drugs
    • Your doctor or nurse should periodically monitor your blood electrolyte levels and administer intravenous replacement as needed

Pregnancy and Nursing

  • Notify your doctor if you are pregnant or if you become pregnant while receiving ERBITUX. Contraception must be used, in both males and females, during ERBITUX therapy and for six months following the last dose of ERBITUX. ERBITUX may be passed from the mother to the developing fetus, and may cause harm to the fetus. ERBITUX should only be used during pregnancy if the potential benefit is greater than the potential risk to the fetus
  • ERBITUX may be passed through human breast milk. Because of the potential for serious side effects in nursing infants from ERBITUX, nursing is not recommended during ERBITUX therapy and for two months following the last dose of ERBITUX

Additional Side Effects

In studies of ERBITUX given to people with metastatic colorectal cancer:

  • The most serious side effects associated with ERBITUX in metastatic colorectal cancer studies were: allergic reactions, skin problems, infection, kidney failure, lung disease, and blood clots in the lung
  • The most frequent side effects associated with ERBITUX (reported in at least 25% of patients) are skin problems (including rash, itching, and nail changes), headache, diarrhea, and infection

In a study where ERBITUX and supportive care were given to 288 people with metastatic colorectal cancer:

  • The most frequent side effects reported were: feeling tired (89%), rash or shedding of the outer layer of the skin (89%), stomach pain (59%), and other pain (51%)
  • Serious side effects reported by at least 10% of patients included: fatigue (33%), other pain (16%), shortness of breath (16%), stomach pain (14%), infection without abnormal decrease in white blood cell count (13%), rash or shedding of the outer layer of skin (12%), and other intestinal problems (10%)

In studies where ERBITUX and irinotecan were given to 354 people with metastatic colorectal cancer:

  • The most frequent side effects reported were: acne-like rash (88%), feeling weakness or discomfort (73%), diarrhea (72%), and nausea (55%)
  • Serious side effects reported by at least 10% of patients included: diarrhea (22%), decrease in white blood cell count (17%), feeling weakness or discomfort (16%), and acne-like rash (14%)
Please see Important Safety Information and U.S. Complete Product Information including Boxed WARNINGS.