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No relevant pharmacokinetic drug–drug interaction between nintedanib and pirfenidone
Open accessAbstract
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 (C max), respectively. In group 2, gMean ratios (with/without nintedanib) were 97.2% and 99.5% for pirfenidone AUC and C max, 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.
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The serum PFD concentration in the clinical setting is around 10 μg/ml.
“It is noteworthy that the serum PFD concentration in the clinical setting is around 10 μg/ml (33).”
From Modeling mechanical activation of macrophages during pulmonary fibrogenesis for targeted anti-fibrosis therapy (2024) · cites this paper as [33]
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Metadata
- Authors
- Richeldi, L., Fletcher, S., Adamali, H., Chaudhuri, N., Wiebe, S., Wind, S., Hohl, K., Baker, A., Schlenker-Herceg, R., Stowasser, S., & Maher, T. M.
- Affiliations
- Università Cattolica del Sacro Cuore (IT)
- University Hospital Southampton NHS Foundation Trust (GB)
- North Bristol NHS Trust (GB)
- Manchester University NHS Foundation Trust (GB)
- Boehringer Ingelheim (Germany) (DE)
- Boehringer Ingelheim (United Kingdom) (GB)
- Royal Brompton & Harefield NHS Foundation Trust (GB)
- ORCID
- Venue
- European Respiratory Journal
- Publisher
- European Respiratory Society (ERS)
- Published
- 2018-11-15
- Volume
- 53
- Issue
- 1
- Pages
- 1801060
- ISSN
- 0903-1936 (ISSN-L)
- 1399-3003
- OpenAlex
- W2901074800
- Cited by
- 34
- References
- 24
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 4 · 2023: 6 · 2022: 4 · 2021: 4 · 2020: 2 · 2019: 7
- FWCI
- 2.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- European Respiratory Journal (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion, other-oa)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- Boehringer Ingelheim
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Pulmonary Hypertension Research and Treatments
- Keywords
- nintedanib, pirfenidone, drug-drug interactions, pharmacokinetics, idiopathic pulmonary fibrosis, antifibrotic therapy, co-administration, drug exposure
- MeSH terms
- Aged, Drug Administration Schedule, Drug Interactions, Drug Therapy, Combination, Female, United Kingdom, Humans, Indoles, Male, Middle Aged, Pyridones, Severity of Illness Index, Treatment Outcome, Idiopathic Pulmonary Fibrosis, Patient Safety
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