Nintedanib Stada (Nintedanib)

Nintedanib is used to target fibrotic lung disease pathways, primarily in progressive interstitial lung conditions.

• Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function.
• Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity.
• Progressive fibrosing interstitial lung disease: delays functional deterioration in patients with other fibrotic ILDs.

• 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 pathways, it reduces fibroblast proliferation, migration, and differentiation, thereby limiting extracellular matrix deposition and attenuating the fibrotic process in lung tissue.

Nintedanib may cause a range of adverse reactions, which are categorized by frequency.

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.
• Weight loss: unintended reduction in body weight.

Serious or Rare Side Effects

• Elevated liver enzymes: potential indication of hepatic injury.
• Bleeding events: increased risk of gastrointestinal or other hemorrhage.
• Cardiovascular events: includes myocardial infarction or stroke.
• Severe infections: opportunistic or serious bacterial infections.
• Gastrointestinal perforation: rare but life‑threatening condition.

When prescribing Nintedanib, clinicians should consider several safety measures.

• Renal function: assess and monitor in patients with impaired kidney function.
• Hepatic function: obtain baseline liver tests and monitor periodically.
• Bleeding risk: avoid concomitant use of strong anticoagulants unless medically necessary.
• Pregnancy: avoid use during pregnancy; limited data, potential fetal risk.
• Drug interactions: review all concomitant medications for CYP3A4 or P‑gp involvement.
• Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.

Nintedanib can interact with other medicines through metabolic pathways and hemostatic effects.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase Nintedanib exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• Antiplatelet agents (e.g., aspirin, clopidogrel): additive hemorrhagic potential.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• P‑glycoprotein inhibitors (e.g., verapamil): modest increase in plasma levels.
• NSAIDs: monitor for gastrointestinal bleeding.