Nipfilan (Nintedanib)

• Nintedanib is used in fibrotic lung disease pathways to reduce progression of scarring.
• Idiopathic pulmonary fibrosis: slows decline in forced vital capacity and reduces risk of disease worsening.
• Systemic sclerosis-associated interstitial lung disease: improves lung function and delays progression of fibrosis.
• Progressive fibrosing interstitial lung disease: provides benefit in patients with other fibrotic lung conditions when alternative treatments are insufficient.

• Nintedanib blocks the intracellular kinase activity of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), platelet‑derived growth factor receptors (PDGFR‑α/β) and fibroblast growth factor receptors (FGFR 1‑3). By inhibiting these pathways, it reduces fibroblast proliferation, migration, and transformation into myofibroblasts, thereby limiting extracellular matrix deposition and the development of fibrotic tissue in the lungs. The combined inhibition curtails the signaling cascades that drive pathological scarring.

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

Common Side Effects

• Nausea: mild to moderate stomach upset.
• Diarrhea: frequent loose stools.
• Vomiting: occasional episodes.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: increase in ALT/AST levels.

Serious or Rare Side Effects

• Hepatic injury: signs of liver failure such as jaundice or elevated bilirubin.
• Arterial thromboembolism: blood clot events that may affect the heart, brain or limbs.
• Severe bleeding: gastrointestinal or intracranial hemorrhage.
• Gastrointestinal perforation: rare but serious ulceration leading to perforation.

Before initiating therapy, clinicians should evaluate several safety considerations.

• Monitor liver function: perform baseline and periodic ALT/AST testing.
• Assess cardiovascular risk: evaluate history of thromboembolic disease before initiating.
• Avoid in severe hepatic impairment: contraindicated in patients with Child‑Pugh C liver disease.
• Use caution with anticoagulants: increased risk of bleeding may occur.
• Adjust dose in renal impairment: consider reduced exposure in moderate renal dysfunction.
• Store at room temperature: keep in original container, protect from moisture and light.

Nintedanib interacts with several drug classes; some combinations should be avoided while others require close monitoring.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Anticoagulants (warfarin, direct oral anticoagulants): heightened bleeding risk.
• Antiplatelet agents (aspirin, clopidogrel): additive bleeding potential.
• P‑gp inhibitors (e.g., verapamil): may raise plasma levels.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase exposure.
• Statins metabolized by CYP3A4 (e.g., simvastatin): monitor for muscle toxicity.
• Diuretics (e.g., furosemide): watch for electrolyte disturbances.
• NSAIDs: may increase gastrointestinal bleeding risk.
• Proton pump inhibitors: possible effect on absorption.