Nintedanib Dr. Reddy’s (Nintedanib)

Nintedanib acts on pathways that drive fibrosis and tumor angiogenesis, making it useful in several serious lung conditions.

• Idiopathic pulmonary fibrosis (IPF): slows the rate of decline in forced vital capacity and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease (SSc‑ILD): limits further loss of lung function and delays worsening of fibrosis.
• Non‑small cell lung cancer (NSCLC) in combination therapy: enhances the efficacy of chemotherapy regimens when used together with standard agents.

• Nintedanib inhibits 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). By blocking these pathways, it reduces angiogenesis, fibroblast proliferation, and extracellular matrix deposition, thereby exerting anti‑fibrotic and anti‑angiogenic effects in target tissues.

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

Common Side Effects

• Diarrhea: frequent loose stools, often requiring supportive care.
• Nausea: feeling of sickness that may affect appetite.
• Vomiting: expulsion of stomach contents.
• Abdominal pain: discomfort or cramping in the stomach area.
• Decreased appetite: reduced desire to eat, potentially leading to weight loss.
• Fatigue: feeling unusually tired or weak.

Serious or Rare Side Effects

• Elevated liver enzymes: may indicate hepatic injury and require monitoring.
• Bleeding events: increased risk of gastrointestinal or other bleeding.
• Cardiovascular events: such as hypertension or arterial thrombotic events.
• Severe infections: opportunistic infections in immunocompromised patients.
• Gastrointestinal perforation: rare but potentially life‑threatening.
• Severe skin reactions: including Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor for adverse events.

• Liver function monitoring: check ALT, AST, and bilirubin regularly.
• Bleeding risk assessment: avoid in patients with active ulcers or uncontrolled anticoagulation.
• Cardiovascular evaluation: monitor blood pressure and cardiac status.
• Gastrointestinal caution: use with care in patients with a history of ulcer disease or perforation.
• Pregnancy and lactation: avoid use unless benefits outweigh unknown risks.
• Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Nintedanib can interact with several drug classes, altering its safety or efficacy.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce effectiveness.
• NSAIDs and antiplatelet agents: monitor for additive bleeding risk.
• Diuretics: watch for electrolyte disturbances.
• Antifungal azoles with moderate inhibition: adjust monitoring as needed.