Iressa (Getfitinib) Drug Information: Overdosage and Contraindications

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May 27, 2012

Iressa

Lung Cancer »

What is lung cancer?

Cancer of the lung, like all cancers, results from an abnormality in the body's basic unit of life, the cell. Normally, the body maintains a system of checks and balances on cell growth so that cells divide to produce new cells only when new cells are needed. Disruption of this system of checks and balances on cell growth results in an uncontrolled division and proliferation of cells that eventually forms a mass known as a tumor.

Tumors can be benign or malignant; when we speak of "cancer," we are referring to those tumors that are malignant. Benign tumors usually can be removed and do not spread to other parts of the body. Malignant tumors, on the other hand, grow aggressively and invade other tissues of the body, allowing entry of tumor cells into the bloodstream or lymphatic system and then to other sites in the body. This process of spread is termed metastasis; the areas of tumor growth at these distant ...

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Iressa

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OVERDOSE

The acute toxicity of gefitinib up to 500 mg in clinical studies has been low. In nonclinical studies, a single dose of 12,000 mg/m² (about 80 times the recommended clinical dose on a mg/m²basis) was lethal to rats. Half this dose caused no mortality in mice.

There is no specific treatment for an IRESSA (getfitinib) 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.