Nintedanib Stada Arzneimittel (Nintedanib)

Nintedanib acts on pathways that drive fibrosis and tumor growth, providing therapeutic benefit in several serious lung conditions.

• 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: used in combination therapy to inhibit tumor growth.

• Nintedanib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR) and platelet‑derived growth factor receptors (PDGFR), as well as non‑receptor kinases. By blocking these pathways it reduces fibroblast proliferation, angiogenesis, and the fibrotic remodeling that underlies pulmonary fibrosis and certain cancers.

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

Common Side Effects

• Diarrhea: frequent, watery stools often occurring early in therapy.
• Nausea and vomiting: mild to moderate gastrointestinal discomfort.
• Abdominal pain: cramping or discomfort in the stomach area.
• Decreased appetite: reduced desire to eat, sometimes leading to weight loss.
• Elevated liver enzymes: mild increases in ALT/AST observed in routine labs.

Serious or Rare Side Effects

• Severe liver injury: rare cases of hepatitis or hepatic failure.
• Major bleeding events: gastrointestinal or intracranial hemorrhage, especially with anticoagulants.
• Cardiovascular complications: hypertension, arterial thromboembolism.
• Gastrointestinal perforation: rare but potentially life‑threatening ulceration.

Before initiating Nintedanib, clinicians should assess patient risk factors and monitor key parameters throughout treatment.

• Liver function monitoring: assess ALT/AST before start and regularly during therapy.
• Bleeding risk: evaluate concomitant anticoagulant or antiplatelet use and adjust as needed.
• Cardiovascular assessment: monitor blood pressure and cardiac status, especially in patients with pre‑existing disease.
• Pregnancy and lactation: safety not established; avoid use in pregnant or nursing women.
• Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original packaging.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampicin): may reduce nintedanib exposure.
• Anticoagulants (e.g., warfarin): heightened risk of serious bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel): increased hemorrhage potential.

Moderate Interactions (Monitor Closely)

• P‑gp inhibitors (e.g., verapamil): may moderately raise plasma levels.
• BCRP inhibitors (e.g., elacridar): may modestly increase exposure.
• Diuretics: monitor electrolytes and renal function when combined.