Nintedanib Sandoz (Nintedanib)

Nintedanib is used to treat progressive fibrotic lung conditions and a specific type of lung cancer.

• Idiopathic pulmonary fibrosis: slows the rate of decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: reduces disease progression.
• 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 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, angiogenesis, and extracellular matrix deposition, thereby limiting fibrosis and tumor vascularisation.

Nintedanib may cause a range of adverse reactions, from mild to serious.

Common Side Effects

• Diarrhea: frequent loose stools.
• Nausea: feeling of sickness.
• Vomiting: expulsion of stomach contents.
• Abdominal pain: discomfort in the stomach area.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: increased ALT/AST levels.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury.
• Hypertension: significant increase in blood pressure.
• Bleeding events: gastrointestinal or other bleeding.
• Cardiovascular events: myocardial infarction or stroke.
• Severe infections: opportunistic infections in immunocompromised patients.

Before initiating therapy, clinicians should assess baseline health and monitor for known risks.

• Liver function monitoring: check ALT/AST before and during treatment.
• Bleeding risk assessment: avoid in patients with active bleeding or uncontrolled anticoagulation.
• Cardiovascular evaluation: monitor blood pressure and cardiac status regularly.
• Pregnancy and lactation: use only if potential benefit justifies potential risk; safety data are lacking.
• Drug interaction review: assess concomitant medications that affect P‑gp or CYP3A4.
• Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and light.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Potent P‑gp inhibitors (e.g., verapamil): can raise plasma concentrations.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise levels.
• P‑gp inducers (e.g., rifampicin): may reduce efficacy.
• Antacids containing magnesium or aluminum: may affect absorption if taken simultaneously.