Nintedanib
Brand Names: Ofev
Methodology & AI Transparency ⓘ
Nintedanib Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: 1 Indications and usage ofev: is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF).
- 2 Real-world patient consensus: 80% patient "Worth It" rating across 14 anonymous logs for Nintedanib (RxNorm 1592742).
- 3 Typical cash cost range: Dispensing cost comparison spans $185.00 mail/discount cash up to $453.25 uninsured retail (federal NADAC $12.0571).
- 4 Top reported side effects / signs: Most commonly reported Nintedanib tolerability events: nausea (11.4%), headache (10%), diarrhea (8.7%).
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Nintedanib Mechanism, CYP450 Pathways & DailyMed Monograph
1 Indications and usage ofev: is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF).
12.1 Mechanism of Action Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, colony stimulating factor 1 receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3). These kinases except for FLT-3 have been implicated in pathogenesis of interstitial lung diseases (ILD).
With Approximately 9–18 hours terminal plasma half-life for Nintedanib residence kinetics and Estimated 65%–77% oral systemic absorption for Nintedanib bioavailability, Nintedanib undergoes hepatic oxidation via cyp3a4/p-gp followed by renal and biliary excretion of nintedanib metabolites and establishes therapeutic activity over peak plasma concentration (tmax) reached 1–3 hours post-dose for nintedanib.
Standard adult regimens span 150 mg/1 Capsule, 100 mg/1 Capsule. Prescribers screen specifically against prior anaphylaxis, angioedema, or severe hypersensitivity to nintedanib or nintedanib excipients; co-administration with prohibited interacting drugs or decompensated organ failure per 2025-11-20 nintedanib spl, while community micro-logs most frequently note nausea (11.4% of reports), headache (10% of reports), diarrhea (8.7% of reports).
Strong CYP3A4 blockade slows first-pass metabolism of Nintedanib, elevating systemic AUC exposure.
Nintedanib may compete for P-gp efflux transport, raising narrow-therapeutic-index digoxin serum levels.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- Prior anaphylaxis, angioedema, or severe hypersensitivity to Nintedanib or Nintedanib excipients
- Co-administration with prohibited interacting drugs or decompensated organ failure per 2025-11-20 Nintedanib SPL
Logged Side-Effect Incidence (14 Reports)
Nintedanib Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Nintedanib)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| Can This Approach Help? Inside the Latest Research on Peripheral Blood Gene Expression Profiling and Prognostic Significance for the Among patients with SSc-ILD in the SENSCIS trial, PBC modules involved in myeloid lineage were associated with. Arthritis & rheumatology (Hoboken, N.J.) • 2025-12-15 • Phase III Randomized Trial | N = 120 | 88/100 | PMID 40420438 ↗ |
| Can This Approach Help? Inside the Latest Research on Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease Based on These analyses of data from the SENSCIS trial suggest that patients with SSc-ILD who are ACA positive or ARA positive can experience progression of SSc-ILD. The Journal of rheumatology • 2025-09-01 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 40233987 ↗ |
| New Insights on Exposure-safety analyses of nintedanib in patients with chronic fibrosing: What a 576-Participant Study Found The positive correlation between exposure and risk of liver enzyme elevations was consistent across nintedanib studies in IPF, SSc-ILD and progressing fibrosing ILDs other than IPF. BMC pulmonary medicine • 2021-07-21 • Phase III Randomized Trial | N = 576 | 87/100 | PMID 34289823 ↗ |
Nintedanib Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $12.0571/unit (~$361.71/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $453.25 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 14 Anonymous DotMD Community Micro-Logs | $185.00 / mo | View logs ↓ |
Nintedanib Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Nintedanib RxNorm Concept ID | 1592742 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $12.0571 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $453.25 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $185.00 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 80.00% Worth It (14 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Nintedanib Patient Community, Cohort Filters & Dosage Logs
Cross-verified Nintedanib (kinase inhibitor) monograph synthesizing RxNorm 1592742, openFDA FAERS signals, and $185.00–$453.25 cash benchmarks.
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