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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 WARNINGS-Pulmonary Toxicity, PRECAUTIONS-Information for Patients and DOSAGE AND ADMINIS-TRATION- Dosage Adjustment sections). In patients receiving IRESSA therapy, there were reports of eye pain and corneal erosion/ ulcer, sometimes in association with aberrant eyelash growth (see PRECAU-TIONS- Information for Patients section). Text Continues Below
There were also rare reports of pancre-atitis and very rare reports of corneal membrane sloughing, ocular ischemia/ hemorrhage, toxic epidermal necrolysis, erythema multiforme, and allergic reactions, including angioedema and urticaria. International Normalized Ratio (INR) elevations and/ or bleeding events have been reported in some patients taking warfarin while on IRESSA therapy. Patients taking warfarin should be monitored regularly for changes in prothrombin time or INR (see CLINICAL PHARMACOLOGY-Drug-Drug Interactions and PRECAUTIONS-Drug Interactions sections). Data from non-clinical (in vitro and in vivo) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarization process (eg, QT interval). The clinical relevance of these findings is unknown. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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