Abstract

ADVERSE DRUG REACTIONS ASSOCIATED WITH INTRAVESICAL BCG THERAPY FOR NON MUSCLE INVASIVE BLADDER CANCER (NMIBC)

Julie Mariam Joshua* and Santhosh M. Mathews

ABSTRACT

Objective: The aim of the study was to identify the incidence and severity of adverse drug reactions following intravesical instillation with bacillus Calmette–Guerin (BCG) for non-muscle invasive bladder cancer (NMIBC). Methods: A total of 101 patients who underwent intravesical BCG instillation for treatment and prophylaxis were included in this study. Adverse drug reactions were divided into local and systemic categories and the severity of reactions was classified according to Hartwigs severity assessment scale. Results: Of 101 patients, 49.5% showed adverse drug reactions. Discontinuation of instillation due to adverse drug reactions was observed in three patients. Local ADRs were found to be more prevalent than systemic and 54% or ADRs are moderate in category. Majority of the ADRs occurred during the first six months of treatment and all ADRs were treated adequately. Conclusion: Even though there was a high rate of adverse drug reactions after intravesical BCG instillation, the rate of serious adverse drug reactions were rare and majority of the ADRs were managed carefully.

Keywords: Bacillus Calmette–Guerin, NMIBC, adverse drug reactions, hartwig’s severity assessment scale, management of ADR.