ImClone.com

Wed, May 14, 2008

INDICATIONS

ERBITUX^® (Cetuximab), in combination with radiation therapy, is indicated for the treatment of a certain type of locally or regionally advanced head and neck cancer.

ERBITUX was also approved 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 who have failed platinum-based chemotherapy.

ERBITUX is available by prescription only and administered intravenously.

IMPORTANT SAFETY INFORMATION

Severe allergic reactions, have occurred in 3% of 1485 patients receiving ERBITUX (Cetuximab) during clinical studies. Symptoms can include trouble with breathing, rash, itching, low blood pressure, and/or heart attack. These reactions are due to ERBITUX infusions and have resulted in death on rare occasions. Your doctor or nurse should watch you closely for these symptoms during treatment. Severe allergic reactions require that treatment with ERBITUX be stopped immediately and not started again.

Heart attack and/or sudden death occurred in 2% of 208 patients with head and neck cancer treated with radiation therapy and ERBITUX. Notify your doctor if you have a history of any heart disease.

Severe cases of lung disease, which can cause death, happened in one of 796 patients with head and neck cancer who were given ERBITUX. Notify your doctor if you develop shortness of breath while receiving ERBITUX. If lung disease is confirmed, ERBITUX treatment should be stopped.

In clinical studies with ERBITUX, skin problems including an acne-like rash, skin drying, cracking, redness, and swelling were seen. Sun exposure may worsen these effects. Patients taking ERBITUX should wear sunscreen and hats to limit sun exposure. A related nail disorder, most often seen in the large toes and thumbs, also was reported.

Death and serious heart problems were seen in a clinical trial with ERBITUX given with a particular type of radiation and cisplatin (a cancer drug) treatment regimen in patients with head and neck cancer. Two patients died and four patients stopped treatment due to side effects. The safety and effectiveness of this regimen has not been established.

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 electrolyte levels and intravenous replacement may be required.

The most serious side effects associated with ERBITUX in combination with radiation therapy in patients with head and neck cancer were allergic reaction (3%), heart attack (2%), acne-like rash (2.5%), mouth sores (6%), skin irritation in the radiation area (3%), confusion (2%), and diarrhea (2%).

The number of late radiation side effects was higher in patients given ERBITUX with radiation therapy compared with patients given radiation therapy alone. The following sites were affected: organs that produce saliva (65%/56%), voice box (52%/36%), tissue below the skin (49%/45%), lining of the mouth and some organs (48%/39%), food pipe (44%/35%), skin (42%/33%), brain (11%/9%), lung (11%/8%), spinal cord (4%/3%), and bone (4%/5%) in the patients given ERBITUX and radiation versus patients given radiation alone, respectively.

The number of severe late radiation side effects were generally similar for patients given radiation therapy alone and patients given ERBITUX plus radiation therapy.

The most common side effects seen in 208 patients with cancer of the head and neck receiving ERBITUX in combination with radiation therapy versus 212 patients given radiation alone (n=212) were mouth sores (93%/94%), acne-like rash (87%/10%), skin irritation in the radiation area (86%/90%), weight loss (84%/72%), dry mouth (72%/71%), difficulty swallowing (65%/63%), feeling weak (56%/49%), nausea (49%/37%), constipation (35%/30%), and vomiting (29%/23%). The most common side effects seen in 103 patients receiving ERBITUX alone were acne-like rash (76%), feeling weak (45%), pain (28%), fever (27%), and weight loss (27%).

For full prescribing information, including BOXED WARNINGS, please click here.

©2006, ImClone Systems Incorporated, New York, NY 10014 USA; All rights reserved. ER-K0034 ERBITUX^® is a registered trademark of ImClone Systems Incorporated.

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