Monoclonal Antibodies: Monitoring of Adverse Reactions and Off-Label Indications in a University Hospital in Southern Brazil

This pharmacovigilance study aimed to monitor the use of monoclonal antibodies in order to investigate possible adverse drug reactions and off-label indications among patients in a university hospital setting. The medical records of adult and pediatric patients were retrospectively reviewed from March to August 2012 as part of an active search for adverse drug reactions. Indications for use of monoclonal antibodies were classified according to approval criteria listed in the drug package insert and Micromedex (R) database, and if not approved, they were classified as off-label use. A total of 91 patients using monoclonal antibodies were monitored during the study period, and off-label use accounted for 39.6% of all indications. Regarding adverse drug reactions, we found a rate of 8.8% of reactions per patient and 3.6% of reactions per 100 patient-days.