OFEV ® (nintedanib) safety Safety data INPULSIS ® -1 & -2 These slides are provided by Boehringer Ingelheim for medical to medical education only. Last updated

Safety endpoints Safety was assessed by clinical and laboratory evaluation and the recording of adverse events Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 16.1 Analyses were descriptive Analyses were based on patients who received ≥1 dose of study medication Richeldi L, et al. N Engl J Med 2014;370:2071–2082.

Most frequent adverse events*: Pooled data Based on adverse events with onset after first dose and up to 28 days after the last dose of trial medication. *Adverse events reported in >10% of patients in either treatment group based on pooled data. †Corresponds to the MedDRA term ‘IPF’, which included disease worsening and IPF exacerbations. Richeldi L, et al. N Engl J Med 2014;370:2071–2082.

Measures recommended in the protocol to manage adverse events Treatment interruption and dose reduction from 150 mg bid to 100 mg bid were recommended for the management of adverse events Following treatment interruption, treatment could be reinstituted at a dose of 150 mg bid or at a dose of 100 mg bid, which could later be increased to 150 mg bid Specific recommendations were provided for the management of diarrhoea and liver enzyme elevations Richeldi L, et al. N Engl J Med 2014;370:2071–2082.

Algorithm for the management of diarrhea adverse events in the INPULSIS ® trials *Recovery defined as <4 extra stools per day. Richeldi L, et al. N Engl J Med 2014;370:2071–2082 Protocol.

Summary of safety findings Nintedanib has a manageable side-effect profile Mild or moderate diarrhoea was the most frequent adverse event in patients treated with nintedanib Approximately 60% of patients treated with nintedanib had at least one diarrhoea adverse event, but fewer than 5% of patients prematurely discontinued nintedanib due to diarrhoea

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