The safety and tolerability of nintedanib in the treatment of idiopathic pulmonary fibrosis

ABSTRACT

Introduction: Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease that primarily affects older individuals. Nintedanib, a tyrosine kinase inhibitor, has been approved for the treatment of IPF in several countries. The safety and tolerability of nintedanib have been investigated in clinical trials and in real-world studies (compassionate use programs and post-marketing surveillance).

Areas covered: Most frequent adverse events reported in patients treated with nintedanib (gastrointestinal); additional adverse events of special interest (elevations in liver enzymes, bleeding, cardiovascular adverse events); recommendations for managing adverse events.

Expert opinion: Experience with nintedanib in real-world clinical practice suggests that it has a safety and tolerability profile consistent with that observed in clinical trials. Upon initiation of nintedanib, patient education, regular monitoring and proactive management of adverse events such as diarrhea are needed to minimize the risk of permanent treatment discontinuation. Algorithms are available to help manage diarrhea and liver enzyme elevations. Further investigation of the safety and tolerability profile of nintedanib when used in combination with pirfenidone is warranted.

KEYWORDS:

• Adverse events
• bleeding
• cardiovascular disease
• diarrhea
• drug surveillance
• post-marketing
• liver function tests
• myocardial infarction

Acknowledgments

The author was fully responsible for all content and editorial decisions, was involved at all stages of manuscript development, and has approved the final version.

Declaration of interest

V cottin has received personal fees from Actelion, Bayer, Biogen Idec, Boehringer Ingelheim, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi, grants from Actelion, Boehringer Ingelheim, GlaxoSmithKline, Pfizer and Roche. Medical writing assistance, provided by Clare Ryles and Wendy Morris of Fleishman Hillard, Fishburn, London, UK, was utilized in the production of this manuscript and supported financially by Boehringer Ingelheim. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

Medical writing assistance was funded by Boehringer Ingelheim.