Iressa - Side Effects & Drug Interactions

gefitinib tablets

• Iressa - Drug Description
• Iressa - Warnings & Precautions
• Iressa - Clinical Pharmacology
• Iressa - Overdosage & Contraindications
• Iressa - Indications & Dosage

ADVERSE REACTIONS

The safety database includes 941 patients from clinical trials and approximately 23,000 patients in the Expanded Access Program. Table 3 includes drug- related adverse events with an incidence of >5% for the 216 patients who received either 250 mg or 500 mg of IRESSA monotherapy for treatment of NSCLC.

The most common adverse events reported at the recom-mended 250 mg daily dose were diarrhea, rash, acne, dry skin, nausea, and vomiting (see PRECAUTIONS-Information for Patients and DOSAGE AND ADMINIS-TRATIONÐ Dosage Adjustment sections). The 500 mg dose showed a higher rate for most of these adverse events. Table 4 provides drug- related adverse events with an incidence of >5% by CTC grade for the patients who received the 250 mg/ day dose of IRESSA monotherapy for treatment of NSCLC. Only 2% of patients stopped therapy due to an adverse drug reaction (ADR). The onset of these ADRs occurred within the first month of therapy.

Other adverse events reported at an incidence of <5% in patients who received either 250 mg or 500 mg as monotherapy for treatment of NSCLC (along with their frequency at the 250 mg recommended dose) include the following:

peripheral edema (2%),

amblyopia (2%),

dyspnea (2%),

conjunctivitis (1%),

vesiculobullous rash (1%),

mouth ulceration (1%).

Interstitial Lung Disease Cases of interstitial lung disease (ILD) have been observed in patients receiving IRESSA at an overall incidence of about 1%. Approximately 1/ 3 of the cases have been fatal. The reported incidence of ILD was about 2% in the Japanese post-marketing experience, about 0.3% in approximately 23,000 patients treated with IRESSA in a US expanded access program and about 1% in the studies of first-line use in NSCLC (but with similar rates in both treatment and placebo groups). Reports have described the adverse event as interstitial pneumonia, pneumonitis and alveolitis.

Patients often present with the acute onset of dyspnea, sometimes associated with cough or low- grade fever, often becoming severe within a short time and requiring hospitalization. ILD has occurred in patients who have received prior radiation therapy (31% of reported cases), prior chemotherapy (57% of reported patients), and no previous therapy (12% of reported cases). Patients with concurrent idiopathic pulmonary fibrosis whose condition worsens while receiving IRESSA have been observed to have an increased mortality compared to those without concurrent idiopathic pulmonary fibrosis.