Nintedanib Accordpharma (Nintedanib)

Nintedanib is used in fibrotic lung disorders and selected oncology settings to target pathways involved in tissue scarring and tumor growth.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delays worsening.
• Non‑small cell lung cancer (in specific settings): contributes to tumor growth inhibition when used as indicated.

• 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). By blocking these signaling pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic processes in the lung and limiting tumor‑related angiogenesis. The combined inhibition curtails pathological remodeling and supports stabilization of pulmonary function.

Nintedanib may be associated with a range of adverse reactions, which are generally categorized by frequency and severity.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness or urge to vomit.
• Vomiting: occasional episodes of expulsion of stomach contents.
• Elevated liver enzymes: increase in ALT/AST detected in blood tests.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury, potentially leading to jaundice.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.
• Severe bleeding: gastrointestinal hemorrhage or other major bleeding episodes.

Before initiating therapy, clinicians should evaluate several safety considerations.

• Liver function monitoring: assess ALT, AST, and bilirubin before and during therapy.
• Bleeding risk assessment: evaluate for anticoagulant use or history of hemorrhage.
• Cardiovascular evaluation: monitor for signs of ischemic events, especially in patients with risk factors.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks, as safety data are limited.
• Drug interactions: review concomitant medications, particularly CYP3A4 substrates and anticoagulants.
• Store at ambient temperature: keep below 25 °C, in the original packaging, protected from moisture and light.

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

Major Interactions (Avoid)

• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may markedly reduce nintedanib exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): increased risk of bleeding.
• Concomitant use with other potent VEGF inhibitors: additive toxicity risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may increase nintedanib levels.
• P‑glycoprotein inhibitors (e.g., verapamil): potential increase in exposure.
• Diuretics: monitor for dehydration which can affect drug tolerability.