Nintedanib Teva (Nintedanib)

• Nintedanib is an antifibrotic agent indicated for progressive fibrotic lung disorders.
• Idiopathic pulmonary fibrosis: slows the decline in forced vital capacity and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: limits worsening of lung fibrosis and improves functional outcomes.
• Other approved fibrotic lung conditions (where applicable): may be used under specialist supervision to manage disease progression.

• 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 attenuating the fibrotic remodeling process in the lung tissue.

Nintedanib may cause a range of adverse reactions, from mild to severe.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: sensation of unease or urge to vomit.
• Vomiting: expulsion of stomach contents.
• Abdominal pain: discomfort in the stomach area.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: increased ALT/AST levels.

Serious or Rare Side Effects

• Hepatic injury: potential liver dysfunction or failure.
• Bleeding events: increased risk of gastrointestinal or other bleeding.
• Cardiovascular events: such as myocardial infarction or stroke.
• Severe infections: opportunistic or serious bacterial infections.
• Gastrointestinal perforation: rare tearing of the GI tract.
• Severe skin reactions: including Stevens‑Johnson syndrome or toxic epidermal necrolysis.

• Patients should be monitored for safety concerns before and during treatment.
• Monitor liver function: obtain baseline and periodic ALT/AST measurements.
• Assess bleeding risk: evaluate concomitant anticoagulant or antiplatelet therapy.
• Evaluate cardiovascular status: watch for signs of ischemic events.
• Use caution in renal impairment: adjust monitoring if creatinine clearance is reduced.
• Avoid in pregnancy unless benefits outweigh risks: safety data are limited.
• Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Nintedanib can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• High‑dose aspirin or NSAIDs: additive bleeding potential.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise levels.
• P‑gp inhibitors (e.g., verapamil): could increase systemic exposure.
• Diuretics: monitor electrolytes and renal function.
• Other antifibrotic agents: assess cumulative hepatic load.