Nintedanib Accord (Nintedanib)

Nintedanib is an antifibrotic and anti‑angiogenic agent used in several serious lung disorders.

• Idiopathic pulmonary fibrosis: slows the decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve respiratory capacity and delays worsening.
• Non‑small cell lung cancer (in combination therapy): contributes to tumor control when used with other anticancer agents.

• 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)—as well as non‑receptor kinases. By blocking these pathways, it reduces fibroblast proliferation, migration, transformation and angiogenesis, thereby limiting fibrotic tissue formation and tumor‑related vascular growth.

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

Common Side Effects

• Diarrhea: frequent loose stools, often manageable with antidiarrheal agents.
• Nausea: feeling of sickness that may lead to reduced oral intake.
• Vomiting: expulsion of stomach contents, sometimes accompanying nausea.
• Abdominal pain: discomfort or cramping in the stomach area.
• Decreased appetite: reduced desire to eat, potentially affecting weight.
• Weight loss: unintended loss of body mass during treatment.

Serious or Rare Side Effects

• Elevated liver enzymes: indicates possible hepatic injury, requiring monitoring.
• Bleeding events: increased risk of gastrointestinal or other hemorrhage.
• Cardiovascular complications: such as hypertension or arterial thrombotic events.
• Severe infections: opportunistic or serious bacterial infections.
• Gastrointestinal perforation: rare but life‑threatening breach of the GI tract.
• Interstitial lung disease exacerbation: worsening of underlying lung disease.

Before initiating therapy, clinicians should evaluate several safety parameters.

• Liver function monitoring: check ALT, AST, and bilirubin regularly.
• Bleeding risk assessment: avoid in patients with active ulcers or on strong anticoagulants.
• Cardiovascular evaluation: screen for uncontrolled hypertension or recent cardiac events.
• Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks.
• Drug interaction review: assess concomitant medications that affect CYP3A4 or P‑gp.
• Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Nintedanib interacts with several drug classes that can alter its exposure or increase adverse events.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may raise nintedanib plasma levels.
• Potent P‑gp inhibitors (e.g., verapamil): can increase systemic exposure.
• Anticoagulants and antiplatelet agents (e.g., warfarin, clopidogrel): heighten bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly increase exposure.
• Moderate P‑gp inhibitors (e.g., amiodarone): require periodic liver function checks.
• Acid‑reducing agents (e.g., proton pump inhibitors): may affect absorption, monitor efficacy.