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Date:10/6/2008

of 1373 patients receiving ERBITUX in clinical trials. Severe acneform rash occurred in 1-17% of patients

- Acneform rash usually developed within the first two weeks of therapy and resolved in a majority of the patients after cessation of treatment, although in nearly half, the event continued beyond 28 days

- Monitor patients receiving ERBITUX for dermatologic toxicities and infectious sequelae
- Sun exposure may exacerbate these effects

ERBITUX plus Radiation Therapy and Cisplatin

-- The safety of ERBITUX in combination with radiation therapy and cisplatin has not been established

- Death and serious cardiotoxicity were observed in a single-arm trial with ERBITUX, radiation therapy, and cisplatin (100 mg/m2) in patients with locally advanced squamous cell carcinoma of the head and neck

- Two of 21 patients died, one as a result of pneumonia and one of an unknown cause

- Four patients discontinued treatment due to adverse events. Two of these discontinuations were due to cardiac events

Electrolyte Depletion

-- Hypomagnesemia occurred in 55% (199/365) of patients receiving ERBITUX and was severe (NCI CTC grades 3 & 4) in 6-17%. The onset of hypomagnesemia and accompanying electrolyte abnormalities occurred days to months after initiation of ERBITUX therapy

- Monitor patients periodically for hypomagnesemia, hypocalcemia and hypokalemia, during, and for at least 8 weeks following the completion of, ERBITUX therapy
- Replete electrolytes as necessary

Late Radiation Toxicities

-- The overall incidence of late radiation toxicities (any grade) was higher with ERBITUX in combination with radiation therapy compared with radiation therapy alone. The following sites were affected: salivary glands (65%/56%), larynx (52%/36%), subcutaneous tissue (49%/45%), mucous membranes (48%/39%), esophagus (44%/35%), and skin (42%/33%) in the ERBITUX and radiation versus radia
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