Nintedanib Biogaran (Nintedanib)

Nintedanib is an antifibrotic agent that targets pathways involved in pulmonary fibrosis.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: improves lung capacity and delays worsening.
• Progressive fibrosing interstitial lung disease: provides benefit in patients with a progressive phenotype.

• Nintedanib inhibits 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 blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby limiting fibrotic tissue formation in the lungs.

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

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may occur with or without vomiting.
• Vomiting: occasional episodes, usually self‑limiting.
• Abdominal pain: discomfort or cramps in the stomach area.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects

• Severe liver injury: jaundice, hepatic failure, requires monitoring.
• Bleeding events: gastrointestinal or pulmonary hemorrhage.
• Cardiovascular events: myocardial infarction or ischemic heart disease.
• Perforated ulcer: severe gastrointestinal perforation.
• Severe infections: opportunistic or bacterial infections.
• Pneumothorax: collapsed lung, especially in advanced disease.

Before initiating therapy, clinicians should consider several safety measures.

• Monitor liver function: obtain baseline ALT/AST and repeat periodically.
• Assess cardiovascular risk: review history of ischemic heart disease or arrhythmias.
• Evaluate bleeding risk: avoid concomitant use of strong anticoagulants when possible.
• Use with caution in gastrointestinal disorders: patients with ulcer disease may need close observation.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
• Store at ambient temperature: keep in the original pack, protect from moisture and heat.

Nintedanib may interact with other medicines, requiring attention to the interaction strength.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
• Anticoagulants (e.g., warfarin): increased risk of bleeding.

Moderate Interactions (Monitor Closely)

• Antiplatelet agents (e.g., aspirin, clopidogrel): may enhance bleeding tendency.
• P‑gp inhibitors (e.g., verapamil): modest increase in plasma levels.
• NSAIDs (e.g., ibuprofen): additive gastrointestinal risk.