Nintedanib Teva (Nintedanib)

• Nintedanib is used in fibrotic lung diseases and selected oncology indications, targeting pathways that promote fibroblast proliferation and tumor growth.
• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilizes respiratory symptoms.
• Non‑small cell lung cancer: used in combination therapy to inhibit tumor angiogenesis and 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 attenuating fibrotic processes 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 manageable with diet and antidiarrheal agents.
• Nausea: feeling of sickness, may be reduced with food intake.
• Vomiting: occasional episodes, usually mild.
• Decreased appetite: reduced desire to eat, can lead to weight loss.
• Abdominal pain: mild to moderate discomfort.
• Elevated liver enzymes: increased ALT/AST on laboratory testing.

Serious or Rare Side Effects

• Hepatic failure: severe liver injury requiring monitoring.
• Major bleeding: gastrointestinal or other hemorrhage, especially with anticoagulants.
• Cardiovascular events: myocardial infarction or stroke in at‑risk patients.
• Gastrointestinal perforation: rare but serious intestinal injury.
• Severe infections: opportunistic infections in immunocompromised individuals.

• Before initiating Nintedanib, several safety considerations should be reviewed.
• Liver function monitoring: perform baseline and periodic liver enzyme tests.
• Cardiovascular assessment: evaluate for history of ischemic heart disease before initiating.
• Bleeding risk: avoid concomitant use with strong anticoagulants unless necessary.
• Gastrointestinal tolerance: manage diarrhea with diet and antidiarrheal agents.
• Pregnancy and lactation: safety not established; avoid use in pregnant or breastfeeding women.
• Store at below 25°C: keep in the original packaging, protect from moisture and light.

Nintedanib can interact with other medicines, requiring attention to the interaction strength.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Potent P‑gp inhibitors (e.g., verapamil): can raise plasma levels.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise concentrations.
• Antacids or proton‑pump inhibitors: may affect absorption; separate dosing by at least 2 hours.
• Calcium channel blockers (e.g., amlodipine): monitor for additive vascular effects.