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.