Nintedanib Lotus (Nintedanib)

Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways, providing therapeutic benefit in several serious lung conditions.

• Idiopathic pulmonary fibrosis: slows disease progression and helps preserve lung function.
• Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity.
• Non‑small cell lung cancer (specific molecular subtypes): inhibits tumor growth when used as part of combination therapy.

• Nintedanib inhibits the intracellular kinase activity of vascular endothelial growth factor receptors (VEGFR‑1, 2, 3), platelet‑derived growth factor receptors (PDGFR‑α, β) and fibroblast growth factor receptors (FGFR‑1, 2, 3). By blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic remodeling and tumor‑driven vascular growth.

Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

• Diarrhoea: often mild to moderate, may require antidiarrhoeal therapy.
• Nausea: usually transient and manageable with food.
• Liver enzyme elevation: monitored through routine blood tests.
• Decreased appetite: may lead to weight loss if persistent.
• Vomiting: generally resolves with supportive care.

Serious or Rare Side Effects

• Severe hepatic injury: indicated by marked transaminase rise, requires discontinuation.
• Cardiovascular events: including myocardial infarction or stroke in high‑risk patients.
• Gastrointestinal perforation: rare but potentially life‑threatening.
• Severe bleeding: especially in patients on anticoagulants.
• Interstitial lung disease exacerbation: requires immediate medical attention.

Before initiating therapy, clinicians should assess baseline organ function and comorbidities.

• Liver function monitoring: obtain baseline tests and repeat periodically.
• Gastrointestinal health: evaluate for pre‑existing conditions that could worsen with treatment.
• Cardiovascular risk: consider patient history of ischemic disease before use.
• Drug interactions: review concomitant medications for potential CYP3A4 involvement.
• Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks.
• Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and direct sunlight.

Nintedanib may interact with drugs that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels and toxicity.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• P‑glycoprotein substrates (e.g., digoxin): potential alteration in drug exposure.
• NSAIDs and antiplatelet agents: monitor for signs of gastrointestinal bleeding.
• Herbal supplements affecting liver enzymes (e.g., St John's wort): assess for possible interaction.