Nintedanib Teva (Nintedanib)

• Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways, providing therapeutic benefit in several lung‑related 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 (in combination with chemotherapy): contributes to tumor growth inhibition and improves progression‑free survival.

• Nintedanib inhibits the intracellular kinase activity of 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 attenuating fibrotic remodeling and tumor‑driven vascular growth.

Nintedanib may cause a range of adverse reactions, from mild to severe. Monitoring and early recognition are important for patient safety.

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Diarrhea: frequent loose stools, often manageable with diet.
• Vomiting: occasional episodes, especially after dose initiation.
• Decreased appetite: reduced food intake leading to weight loss.
• Abdominal pain: discomfort in the upper abdomen.
• Elevated liver enzymes: transient increases in ALT/AST.

Serious or Rare Side Effects

• Hepatic failure: severe liver injury requiring discontinuation.
• Major bleeding: gastrointestinal or intracranial hemorrhage.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.
• Gastrointestinal perforation: rare but potentially life‑threatening.
• Severe infections: opportunistic infections in immunocompromised patients.

Before initiating Nintedanib, clinicians should evaluate patient‑specific factors and monitor for potential complications.

• Renal function: assess baseline and monitor during therapy.
• Hepatic function: avoid in patients with severe liver impairment; monitor enzymes regularly.
• Bleeding risk: use caution with anticoagulants or antiplatelet agents.
• Pregnancy and lactation: contraindicated unless benefit outweighs risk; discuss with obstetric specialist.
• Drug interactions: review concomitant medications for CYP3A4 substrates and P‑gp inhibitors.
• Store at ambient temperature: keep below 25 °C, protect from moisture and light in original packaging.

Nintedanib can interact with several drug classes, influencing its exposure and safety profile.

Major Interactions (Avoid)

• Strong CYP3A4 inducers (e.g., rifampicin): may markedly reduce nintedanib exposure.
• Anticoagulants (e.g., warfarin): increased risk of serious bleeding.
• Potent P‑gp inhibitors combined with strong CYP3A4 inhibitors: may lead to toxic plasma levels.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., ketoconazole): may increase plasma concentrations; dose adjustment may be needed.
• Antifungal azoles: require careful monitoring of liver function and possible dose modification.
• Diuretics: monitor electrolytes and renal function due to potential additive effects on fluid balance.