Iressa

[gefitinib tablets]

Warnings & Precautions
WARNINGS

Pulmonary Toxicity

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.

Text Continues Below

---

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.

In the event of acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever), IRESSA therapy should be interrupted and a prompt investigation of these symptoms should occur. If interstitial lung disease is confirmed, IRESSA should be discontinued and the patient treated appropriately (see PRECAUTIONS-Information for Patients, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION-Dosage Adjustment sections).

Pregnancy Category D

IRESSA may cause fetal harm when administered to a pregnant woman. A single dose study in rats showed that gefitinib crosses the placenta after an oral dose of 5 mg/ kg (30 mg/ m 2 , about 1/ 5 the recommended human dose on a mg/ m 2 basis). When pregnant rats were treated with 5 mg/ kg from the beginning of organogenesis to the end of weaning gave birth, there was a reduction in the number of offspring born alive. This effect was more severe at 20 mg/ kg and was accompanied by high neonatal mortality soon after parturition. In this study a dose of 1 mg/ kg caused no adverse effects.

Page:  1 | 2 | 3 | 4 | Next >>