Nintedanib Teva (Nintedanib)

Nintedanib is indicated for fibrotic lung diseases and certain oncologic indications, where it targets pathways that drive fibrosis and tumor growth. It is approved in the European Union for the treatment of these conditions based on clinical trial evidence demonstrating efficacy in slowing functional decline.

• Idiopathic pulmonary fibrosis: slows disease progression and helps preserve lung function.
• Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity and improves quality of life.
• Non‑small cell lung cancer (in combination therapy): inhibits tumor angiogenesis and may extend progression‑free survival.

• Nintedanib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), fibroblast growth factor receptors (FGFR 1‑3) and platelet‑derived growth factor receptors (PDGFR‑α/β). By blocking these pathways, the drug reduces endothelial cell proliferation, fibroblast activation, and extracellular matrix deposition, thereby limiting angiogenesis and fibrotic remodeling in lung tissue and tumor micro‑environments. The inhibition is dose‑dependent and results in decreased signaling that drives pathological tissue remodeling.

Nintedanib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

• Diarrhea: frequent watery stools that may lead to dehydration.
• Nausea: feeling of sickness often accompanied by loss of appetite.
• Vomiting: occasional expulsion of stomach contents.
• Elevated liver enzymes: mild increases in ALT/AST observed in blood tests.
• Abdominal pain: discomfort in the stomach area.
• Fatigue: persistent tiredness.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury requiring discontinuation.
• Bleeding events: gastrointestinal or pulmonary hemorrhage.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.
• Severe hypersensitivity: rash, angioedema, or anaphylaxis.

When prescribing Nintedanib, clinicians should consider several safety precautions to minimize risk.

• Liver function monitoring: assess ALT/AST before treatment and periodically during therapy.
• Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea promptly.
• Bleeding risk assessment: avoid use in patients with active ulcers or on anticoagulants without supervision.
• Pregnancy and lactation: contraindicated unless benefits outweigh potential fetal risks; discuss with obstetric specialist.
• Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture and light.

Nintedanib can interact with other medicines that affect its absorption, metabolism, or hemostatic balance.

Major Interactions (Avoid)

• Strong P‑gp inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure and toxicity.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.
• High‑dose aspirin or NSAIDs: additive bleeding potential.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise plasma levels.
• Antacids or proton pump inhibitors: can reduce oral absorption; separate dosing by at least 2 hours.
• Herbal supplements containing St. John’s wort: may lower drug concentrations.