Nintedanib Accordpharma (Nintedanib)

Nintedanib acts on fibrotic lung disease pathways and is approved for several interstitial lung conditions.

• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and delays worsening.
• Progressive fibrosing interstitial lung disease: helps limit further fibrosis across multiple underlying causes.

• 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, migration, and angiogenesis, thereby limiting extracellular matrix deposition and the development of fibrotic tissue in the lungs.

Nintedanib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may be transient.
• Vomiting: occasional episodes, usually early in treatment.
• Abdominal pain: discomfort or cramping in the stomach area.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects

• Hepatic injury: signs of liver dysfunction such as jaundice.
• Bleeding events: gastrointestinal or other hemorrhage, especially with anticoagulants.
• Cardiovascular events: myocardial infarction or stroke in high‑risk patients.
• Severe infections: opportunistic or serious bacterial infections.
• Gastrointestinal perforation: rare but potentially life‑threatening.

Before initiating therapy, clinicians should assess several safety considerations.

• Liver monitoring: obtain baseline liver function tests and repeat periodically.
• Cardiovascular risk: evaluate history of ischemic heart disease or stroke.
• Bleeding risk: review concomitant anticoagulant or antiplatelet use.
• Gastrointestinal health: use caution in patients with ulcer disease or recent surgery.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
• Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Nintedanib can interact with other medicines, requiring attention to avoid altered exposure or increased toxicity.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may raise nintedanib levels.
• Anticoagulants (e.g., warfarin): increased risk of bleeding.
• High‑dose aspirin or other antiplatelet agents: heightened bleeding potential.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly increase exposure.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce effectiveness.
• P‑gp inhibitors (e.g., verapamil): could elevate plasma concentrations.
• NSAIDs: monitor for signs of gastrointestinal bleeding.