No relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone
File(s)
Author(s)
Type
Journal Article
Abstract
Nintedanib and pirfenidone are approved treatments for idiopathic pulmonary fibrosis (IPF). This open-label, two-group trial investigated the pharmacokinetic drug-drug interaction between these two drugs in patients with IPF.Subjects not treated with antifibrotics at screening (Group 1, n=20) received a single nintedanib dose (150 mg) followed by pirfenidone (titrated to 801 mg thrice-daily) for 3 weeks, with a further single nintedanib dose (150 mg) on the last day (day 23). Subjects treated with pirfenidone at screening (Group 2, n=17) continued to receive pirfenidone alone (801 mg thrice-daily) for 7 days, then co-administered with nintedanib (150 mg twice-daily) for a further 7 days, before single doses of both treatments on day 16.In Group 1, adjusted geometric mean (gMean) ratios (with/without pirfenidone) were 88.6% and 80.6% for nintedanib area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax), respectively. In Group 2, gMean ratios (with/without nintedanib) were 97.2% and 99.5% for pirfenidone AUC and Cmax, respectively. For all parameters, the 90% confidence intervals included 100%, suggesting similar exposure for administration alone and when co-administered. Both treatments were well tolerated.These data indicate there is no relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone when co-administered in IPF patients.
Date Issued
2019-01-10
Date Acceptance
2018-11-01
Citation
European Respiratory Journal, 2019, 53 (1)
ISSN
0903-1936
Publisher
European Respiratory Society
Journal / Book Title
European Respiratory Journal
Volume
53
Issue
1
Copyright Statement
© 2018 European Respiratory Society. This is an author-submitted, peer-reviewed version of a manuscript that has been accepted for publication in the European Respiratory Journal, prior to copy-editing, formatting and typesetting. This version of the manuscript may not be duplicated or reproduced without prior permission from the copyright owner, the European Respiratory Society. The publisher is not responsible or liable for any errors or omissions in this version of the manuscript or in any version derived from it by any other parties. The final, copy-edited, published article, which is the version of record, is available without a subscription 18 months after the date of issue publication.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30442716
PII: 13993003.01060-2018
Subjects
11 Medical And Health Sciences
Respiratory System
Publication Status
Published
Coverage Spatial
England
Article Number
1801060
Date Publish Online
2018-11-15