Real-world safety data for tbo-filgrastim.

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e17540 Background: Medical products registered in the European Union (EU) are subject to Periodic Safety Update Reports (PSURs), which provide comprehensive worldwide safety data assessments and benefit-risk analyses. Methods: The present PSUR for tbo-filgrastim-containing products within the TEVA group (Tevagrastim, Biograstim, Ratiograstim [marketed in the US as Granix]) analyzed safety data accumulated between April 1, 2012 and March 31, 2013 in 38 countries. Cumulative data were collected from clinical trials and post-marketing sources from September 15, 2008 (initial approval) to the end of the current PSUR period, March 31, 2013. Data were collected from spontaneous reports from healthcare professionals, consumers, scientific literature, competent authorities, and solicited case reports. Adverse reactions were categorized by system organ class (SOC), source, and seriousness. Teva pharmacovigilance requires screening of all adverse reaction reports and antibody assessment for cases of suspected immunogenicity. Results: From September 15, 2008 (initial approval) to the end of the current PSUR period, March 31, 2013, the estimated cumulative exposure to products containing tbo-filgrastim was ~4,474,929 patient-days. Estimated cumulative exposure to tbo-filgrastim in clinical trials in healthy subjects and patients with cancer was 190 and 22,099 patient-days, respectively. The global safety database processed 254 tbo-filgrastim case reports from initial product approval through March 31, 2013 (~4.5 years), including 61 (24%) from the PSUR period. Post-marketing data sources cumulatively reported 461 adverse reactions, 131 (28%) from the PSUR period. The most commonly occurring preferred terms in association with important identified and potential risks over the cumulative period were allergic type reactions (11), interstitial pneumonia (4), and splenomegaly (2). Eleven new cases were identified that required immunogenicity testing during the PSUR period. The most common reasons for requiring testing were lack of efficacy (n=7) and type II hypersensitivity (n=2). Conclusions: No new safety risks were identified for tbo-filgrastim based on PSUR data from the most recent reporting period ending March 31, 2013.