dotMD.com
Kinase Inhibitor • Prescription (Rx)

Nintedanib

Brand Names: Ofev

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-11-20 • RxNorm RxCUI 1592742 • 7 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Nintedanib Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

80%
Patient “Worth It” (14)
$185.00
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Nintedanib

3 of 3 Free Questions Remaining
Dr. Vance (AI Pharmacology & Interaction Agent)

Nintedanib Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1592742 • NDC 0597-0143

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).

CYP450 & Metabolic Pathways: CYP3A4 P-gp
Key Monitored Interactions:
Potent CYP3A4 Inhibitors (Azoles, Clarithromycin, Ritonavir) Major

Strong CYP3A4 blockade slows first-pass metabolism of Nintedanib, elevating systemic AUC exposure.

Digoxin & P-Glycoprotein Efflux Substrates Moderate

Nintedanib may compete for P-gp efflux transport, raising narrow-therapeutic-index digoxin serum levels.

Half-Life
Approximately 9–18 hours terminal plasma half-life for Nintedanib
Bioavailability
Estimated 65%–77% oral systemic absorption for Nintedanib
Metabolism & Clearance
Hepatic oxidation via CYP3A4/P-gp followed by renal and biliary excretion of Nintedanib metabolites
Clinical Onset
Peak plasma concentration (Tmax) reached 1–3 hours post-dose for Nintedanib

Standard Adult Titration & Dosages

150 mg/1 Capsule 100 mg/1 Capsule

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)

Nausea 11.4%
Headache 10%
Diarrhea 8.7%
Vomiting 5%
Decreased appetite 4.3%
Abdominal discomfort 4.2%
Elena Rostova (AI Biostatistician & openFDA Quant)

Nintedanib Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (14)
Nausea FAERS: 11.4% • Logs: 11.4%
Diarrhea FAERS: 8.7% • Logs: 8.7%
Headache FAERS: 10% • Logs: 10%
Vomiting FAERS: 5% • Logs: 5%
Decreased appetite FAERS: 4.3% • Logs: 4.3%
Abdominal discomfort FAERS: 4.2% • Logs: 4.2%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Nintedanib)

Browse All PubMed Translations →
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 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Nintedanib Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1592742
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
Zero-PHI Patient Community & 15-Second Dosage Logger

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.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Nintedanib community threads and patient logs by age, biological sex, dosage, and treatment duration.

No threads match this cohort filter yet. Click + Start Anonymous Discussion to ask the community about Nintedanib.

Recent Verified Anonymous Patient Micro-Logs (0)