Nintedanib Sandoz (Nintedanib)

• Nintedanib is used in fibrotic lung disorders and selected oncology settings, targeting disease pathways that involve abnormal fibroblast activity and tumor growth.
• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve pulmonary capacity and delay worsening.
• Non‑small cell lung cancer: used in combination therapy to inhibit tumor angiogenesis and growth.

• Nintedanib blocks 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)—as well as non‑receptor kinases such as Src. By inhibiting these pathways, it reduces endothelial cell proliferation, angiogenesis, and fibroblast activation, thereby limiting fibrotic tissue formation and tumor vascularization.

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

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may accompany meals.
• Vomiting: occasional episodes.
• Decreased appetite: reduced desire to eat.

Serious or Rare Side Effects

• Liver enzyme elevation: significant increase in ALT/AST indicating potential hepatotoxicity.
• Gastrointestinal perforation: rare but severe tearing of the intestinal wall.
• Severe bleeding: hemorrhagic events, especially when combined with anticoagulants.

When prescribing Nintedanib, clinicians should observe several precautionary measures to ensure patient safety.

• Monitor liver function: check ALT/AST before starting and periodically during therapy.
• Assess bleeding risk: avoid in patients with active hemorrhage or on strong anticoagulants.
• Evaluate cardiovascular status: caution in patients with recent myocardial infarction or uncontrolled hypertension.
• Avoid use in severe hepatic impairment: contraindicated in patients with Child‑Pugh C liver disease.
• Use effective contraception: women of childbearing potential should employ reliable birth control during treatment and for at least one month after discontinuation.
• Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure and risk of toxicity.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel) in high‑dose regimens: may exacerbate hemorrhagic events.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin): may modestly raise plasma levels.
• P‑glycoprotein inhibitors (e.g., verapamil): can increase nintedanib concentrations.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce drug exposure, potentially decreasing efficacy.