Herceptin Serious Infusion-Related AEs Hold At .25% Of Patients - Genentech
Executive Summary
The reporting rate for serious infusion-related adverse events for Genentech's breast cancer agent Herceptin (trastuzumab) has not changed from the .25% of treated patients reported in May, the company indicated after issuing a "Dear Doctor" letter Oct. 6 notifying healthcare professionals of updates to warnings in labeling.
|
The reporting rate for serious infusion-related adverse events for Genentech's breast cancer agent Herceptin (trastuzumab) has not changed from the .25% of treated patients reported in May, the company indicated after issuing a "Dear Doctor" letter Oct. 6 notifying healthcare professionals of updates to warnings in labeling. The Oct. 6 letter is a follow up to a May 3 "Dear Doctor" letter discussing reports of serious hypersensitivity, infusion and pulmonary reactions in patients being treated with Herceptin. The May letter noted that 62 postmarketing reports of adverse events with Herceptin had been received, including 15 deaths out of a total of 25,000 patients who were treated with the drug (1 (Also see "Herceptin Should Be Used With Caution In Pulmonary Compromised Patients" - Pink Sheet, 8 May, 2000.)). Administration of Herceptin "can result in severe hypersensitivity reactions (including anaphylaxis), infusion reactions, and pulmonary events," the revised boxed warning states. "Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension," labeling says. "Patients should be monitored until signs and symptoms completely resolve." "Discontinuation of Herceptin treatment should be strongly considered for patients who develop analphylaxis, angioedema, or acute respiratory distress syndrome," the warning adds. Labeling notes that "there are no data regarding the most appropriate method of identification of patients who may safely be retreated with Herceptin after experiencing" a severe hypersensitivity or infusion reaction. Before readministration, the majority of patients who had a severe hypersensitivity or infusion reaction "were prophylactically treated with pre-medications including antihistamines and/or corticosteroids," labeling states. "While some of these patients tolerated retreatment, others had severe reactions again despite the use of prophylactic medications." Labeling also carries a warning that "patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea of the lungs [who] may be at greater risk of severe reactions." |