Iressa

[gefitinib tablets]

Overdosage & Contraindications
CONTRAINDICATIONS

IRESSA is contraindicated in patients with severe hypersensitivity to gefitinib or to any other component of IRESSA.

OVERDOSAGE

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The acute toxicity of gefitinib up to 500 mg in clinical studies has been low. In non-clinical studies, a single dose of 12,000 mg/ m 2 (about 80 times the recommended clinical dose on a mg/ m 2 basis) was lethal to rats. Half this dose caused no mortality in mice. There is no specific treatment for an IRESSA overdose and possible symptoms of overdose are not established.

However, in phase 1 clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase in frequency and severity of some adverse reactions was observed, mainly diarrhea and skin rash. Adverse reactions associated with overdose should be treated symptomatically; in particular, severe diarrhea should be managed appropriately.