Ofev (Nintedanib)
Brand Names: Ofev
Methodology & AI Transparency ⓘ
Ofev (Nintedanib) Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: Distinguished by trade identifier Ofev and registered by Boehringer Ingelheim Pharmaceuticals, Inc., this kinase inhibitor product delivers active moiety Nintedanib (cross-referenced at /meds/nintedanib) (100 mg/1 Capsule; 150 mg/1 Capsule).
- 2 Real-world patient consensus: Ofev links directly to generic Nintedanib (/meds/nintedanib) under FDA SPL 2025-11-20 (NDC 0597-0143).
- 3 Typical cash cost range: Dispensing cost comparison spans $166.00 mail/discount cash up to $439.90 uninsured retail (federal NADAC $16.1772).
- 4 Top reported side effects / signs: Primary clinical safety signals tracked in FAERS for Ofev (Nintedanib) include nausea (11.8%), headache (10.4%), diarrhea (9.1%).
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Ofev (Nintedanib) Mechanism, CYP450 Pathways & DailyMed Monograph
Distinguished by trade identifier Ofev and registered by Boehringer Ingelheim Pharmaceuticals, Inc., this kinase inhibitor product delivers active moiety Nintedanib (cross-referenced at /meds/nintedanib) (100 mg/1 Capsule; 150 mg/1 Capsule). Federal labeling (2025-11-20, RxCUI 1592748) defines its therapeutic scope: 1 Indications and usage ofev: is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis.
Inside Ofev, Nintedanib mediates kinase inhibitor pharmacodynamics involving CYP3A4/P-gp clearance pathways across labeled adult regimens (100 mg/1 Capsule; 150 mg/1 Capsule). Commercial labeling registered by Boehringer Ingelheim Pharmaceuticals, Inc. (SPL 2025-11-20, RxNorm 1592748) pairs standardized excipient stability with federal price transparency metrics ($16.1772/unit NADAC; $439.90 retail average).
With Terminal t½ estimated at 4–13 hrs depending on renal/hepatic reserve (Ofev (Nintedanib)) residence kinetics and F ≈ 64%–76% systemic availability after standard oral Ofev (Nintedanib) administration bioavailability, Ofev (Nintedanib) undergoes ofev (nintedanib) undergoes cyp3a4/p-gp-mediated hepatic metabolism prior to excretion and establishes therapeutic activity over time to peak concentration spans 1 to 3 hrs under ofev (nintedanib) maintenance.
Standard adult regimens span 100 mg/1 Capsule, 150 mg/1 Capsule, 100mg Capsule. Prescribers screen specifically against known hypersensitivity to nintedanib or structurally related kinase inhibitor compounds; concomitant contra-labeled cyp/transporter therapies during active ofev (nintedanib) administration, while community micro-logs most frequently note nausea (11.8% of reports), headache (10.4% of reports), diarrhea (9.1% of reports).
Strong CYP3A4 blockade slows first-pass metabolism of Ofev (Nintedanib), elevating systemic AUC exposure.
Ofev (Nintedanib) may compete for P-gp efflux transport, raising narrow-therapeutic-index digoxin serum levels.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- Known hypersensitivity to Nintedanib or structurally related kinase inhibitor compounds
- Concomitant contra-labeled CYP/transporter therapies during active Ofev (Nintedanib) administration
Logged Side-Effect Incidence (6 Reports)
Ofev (Nintedanib) Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Ofev (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 ↗ |
Ofev (Nintedanib) Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $16.1772/unit (~$485.32/30u) | Wholesale baseline |
| Mark Cuban Cost Plus Drugs (Mail-Order Generic) | Public Wholesale Price List (NADAC + 15% + pharmacy fee) | $166.00 / mo | Formulary listing ↗ |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $439.90 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 6 Anonymous DotMD Community Micro-Logs | $190.90 / mo | View logs ↓ |
Ofev (Nintedanib) Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Ofev (Nintedanib) RxNorm Concept ID | 1592748 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $16.1772 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $439.90 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $166.00 / mo (Cost Plus Drugs) | Mark Cuban Cost Plus Public API |
| Real-World Patient Consensus | 93.00% Worth It (6 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Ofev (Nintedanib) Patient Community, Cohort Filters & Dosage Logs
Deterministic Ofev (Nintedanib) reference combining NIH RxNorm (1592748), Medicaid NADAC ($16.1772/unit), and anonymous cohort outcomes (93% Worth It).
Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.
Filter Ofev (Nintedanib) community threads and patient logs by age, biological sex, dosage, and treatment duration.