Nintedanib Stada (Nintedanib)

Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncologic pathways, providing therapeutic benefit in several serious lung diseases.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary capacity and delays worsening.
• Non‑small cell lung cancer: inhibits tumor growth when used in combination with standard chemotherapy.

• Nintedanib inhibits a spectrum of 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, angiogenesis, and extracellular matrix deposition, thereby limiting fibrotic remodeling and tumor angiogenesis.

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

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: sensation of queasiness, may affect appetite.
• Abdominal pain: discomfort in the stomach area.
• Decreased appetite: reduced desire to eat.
• Vomiting: expulsion of stomach contents.
• Weight loss: unintended reduction in body weight.

Serious or Rare Side Effects

• Elevated liver enzymes: indicates potential hepatic injury.
• Bleeding events: increased risk of gastrointestinal or other bleeding.
• Cardiovascular events: such as hypertension or arterial thromboembolism.
• Severe infections: opportunistic infections in immunocompromised patients.
• Gastrointestinal perforation: rare but life‑threatening condition.
• Interstitial lung disease exacerbation: worsening of underlying lung disease.

Before initiating therapy with Nintedanib, clinicians should consider several safety measures.

• Liver function monitoring: assess baseline enzymes and repeat periodically.
• Cardiovascular assessment: evaluate blood pressure and history of thrombotic disease.
• Bleeding risk evaluation: review concomitant anticoagulant or antiplatelet use.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
• Hepatic impairment dose adjustment: consider reduced dosing in moderate liver dysfunction.
• Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Nintedanib may interact with other medicines, altering its efficacy or safety profile.

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 bleeding potential.
• P‑gp inhibitors (e.g., verapamil): can raise plasma concentrations.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce effectiveness.
• Diuretics: monitor for electrolyte disturbances.
• Antihypertensives: watch for additive blood pressure effects.
• St. John's wort: possible reduction in drug levels.
• Herbal supplements affecting liver enzymes: assess on a case‑by‑case basis.