Nintedanib Stada (Nintedanib)

• Nintedanib is an antifibrotic agent that targets progressive fibrotic lung disorders.
• Idiopathic pulmonary fibrosis: slows the decline in forced vital capacity and improves survival.
• Systemic sclerosis‑associated interstitial lung disease: reduces the rate of lung function deterioration.
• Progressive fibrosing interstitial lung disease (non‑IPF): attenuates disease progression in patients with a fibrotic 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, migration, and differentiation, thereby limiting extracellular matrix deposition and the progression of fibrotic tissue in the lungs.

Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

• Diarrhea: frequent, often mild to moderate.
• Nausea: may occur after dosing.
• Vomiting: occasional, usually self‑limiting.
• Abdominal pain: mild discomfort reported.
• Decreased appetite: reduced food intake.
• Weight loss: modest, related to gastrointestinal effects.

Serious or Rare Side Effects

• Elevated liver enzymes (ALT/AST): may indicate hepatic injury.
• Bleeding events: increased risk of gastrointestinal or other hemorrhage.
• Cardiovascular events: such as myocardial infarction or stroke.
• Severe infections: opportunistic infections reported.
• Gastrointestinal perforation: rare but serious complication.
• Worsening of interstitial lung disease: rare progression despite therapy.

• When prescribing Nintedanib, clinicians should consider several safety measures.
• Monitor liver function: check ALT/AST before initiation and periodically thereafter.
• Assess bleeding risk: avoid in patients with active ulcers or on strong anticoagulants.
• Evaluate cardiovascular status: caution in patients with recent myocardial infarction or stroke.
• Counsel on gastrointestinal symptoms: advise patients to report persistent diarrhea or abdominal pain.
• Avoid use in severe hepatic impairment: contraindicated in patients with Child‑Pugh C.
• Store at below 25°C: keep in the original pack, protect from moisture.

Nintedanib may interact with other medicines that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels.
• Potent P‑glycoprotein inhibitors (e.g., itraconazole): can increase exposure.
• Anticoagulants (e.g., warfarin) at high doses: heightened bleeding risk.

Moderate Interactions (Monitor Closely):\n- Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase concentrations.

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Non‑steroidal anti‑inflammatory drugs (NSAIDs): monitor for gastrointestinal bleeding.