Tyrosine kinase inhibitors
ATC code: L01EX09 (Nintedanib)
Brand names
Nintedanib Dr. Reddys, Ofev, Vargatef, Nintedanib Zentiva
Small molecule – multi-kinase inhibitor of VEGFR-1/2/3, FGFR-1/2/3, PDGFR-α/β receptor tyrosine kinases. These signals are critical for fibroblast proliferation, angiogenesis, and inflammation in lung fibrosis pathogenesis. Slows IPF progression but does not halt it. Also used in systemic sclerosis with interstitial lung disease (SSc-ILD) and metastatic non-small cell lung cancer (only oncology form – Vargatef).
First line
First-line IPF therapy per ATS/ERS/JRS/ALAT 2022 and Spanish SEPAR 2023 – on par with pirfenidone. Dose 150 mg twice daily. INPULSIS-1 and INPULSIS-2 (NEJM 2014) reduced FVC decline by 50% (~100 mL/year vs 200 mL). Direct mortality benefit not proven, but meta-analyses show a downward trend. Duration – lifelong until intolerance or lung transplantation.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Nintedanib is a tyrosine kinase inhibitor. It is prescribed for idiopathic pulmonary fibrosis and other interstitial lung diseases with progressive fibrosis (AEMPS Ficha Técnica, INPULSIS 2014). In alt-anti-aging circles, nintedanib is occasionally promoted to suppress fibrosis of aging in healthy people. In healthy adults, no clinical studies of such use exist. The drug has serious risks: hepatotoxicity up to severe liver injury, GI disturbances (severe diarrhea in 60% of patients), elevated bleeding risk (especially on anticoagulants), hypertension, and thromboembolic events. If nintedanib was recommended to a healthy person, seek a second opinion immediately.
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Teratogenic in animal studies. Contraindicated. Barrier contraception or IUD mandatory throughout therapy and 3 months after.
No milk excretion data. Discontinue breastfeeding.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Nintedanib is evaluated for the following indications with varying evidence strength: Idiopathic pulmonary fibrosis (evidence tier A), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Nintedanib (≥ 1 in 100): Diarrhea (60-70%), Nausea, Vomiting, Abdominal pain, Weight loss, ALT/AST elevation. See the Safety section for uncommon and serious reactions.
FDA category D. Teratogenic in animal studies. Contraindicated. Barrier contraception or IUD mandatory throughout therapy and 3 months after.
No milk excretion data. Discontinue breastfeeding.
Nintedanib is contraindicated in: Hypersensitivity; Pregnancy; Severe hepatic impairment Child-Pugh B-C; Age under 18 (except specific pediatric indications). Full list in the Safety section.