Combined nintedanib and anticoagulation therapy does not increase the risk of bleeding in individuals with pulmonary fibrosis. A real world retrospective study.

Introduction: Nintedanib is a tyrosine kinase inhibitor licenced for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Nintedanib’s inhibition of vascular endothelial growth factor leads to a potential risk of bleeding. Bleeding events were 8.4 events per 100 patient exposure years in clinical trials [1] despite excluding patients on anticoagulation (AC) therapy. The summary of product characteristics states “Non serious and serious bleeding events, some of which were fatal, have been reported in the post marketing period (including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding). Therefore, these patients should only be treated with nintedanib if the anticipated benefit outweighs the potential risk.” [2]

Methods: We performed a single centre retrospective analysis of bleeding adverse events in all patients prescribed nintedanib between August 22 and July 23. Electronic patient records were reviewed. Treatment was censored up to December 2024.

Results: A total of 65 patients were prescribed nintedanib: 41 IPF (63%) 24 PPF (37%). 47 Male 35 (54%) on reduced dose 100mg bd. Patients were treated for a median+/-standard deviation 18+/- 8.4 month (range 1-27). 14 (21.5%) were on AC (13 for atrial fibrillation (12 apixaban (8 5mg bd and 4 2.5mg bd) 1 rivoroxaban) 1 warfarin for a mechanical valve). There were 6 (9.2%) bleeding events, 4 in patients prescribed nintedanib only and 2 in patients on AC and nintedanib.

Conclusion: There were no increased bleeding events in our real world study in patients prescribed AC and nintedanib.