Nintedanib Sandoz (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 the decline in forced vital capacity and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: limits further fibrosis and preserves lung function.
• Non‑small cell lung cancer (in combination therapy): inhibits tumor angiogenesis and growth when used with standard chemotherapy.

• 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 endothelial cell proliferation, fibroblast activation, and extracellular matrix deposition, thereby attenuating angiogenesis and fibrotic remodeling in lung tissue and tumor micro‑environments.

Adverse reactions may occur with any medication. The following lists have been compiled from clinical experience and product labeling.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may be transient.
• Vomiting: occasional episodes, usually self‑limiting.
• Abdominal pain: discomfort or cramping in the stomach area.
• Decreased appetite: reduced desire to eat.
• Weight loss: unintended loss of body weight.

Serious or Rare Side Effects

• Elevated liver enzymes: indicates possible hepatic injury.
• Bleeding events: including gastrointestinal hemorrhage.
• Cardiovascular complications: such as hypertension or arterial thromboembolism.
• Severe infections: opportunistic or bacterial infections.
• Gastrointestinal perforation: rare but potentially life‑threatening.

Before initiating therapy, clinicians should assess patient‑specific risk factors and monitor relevant parameters.

• Liver function monitoring: obtain baseline and periodic liver enzyme tests.
• Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use.
• Cardiovascular evaluation: screen for hypertension or cardiac disease.
• Gastrointestinal health: caution in patients with a history of ulcers or perforation.
• Pregnancy and lactation: avoid use unless benefits clearly outweigh risks.
• Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): increase bleeding potential.
• Antiplatelet agents (e.g., clopidogrel, high‑dose aspirin): heighten risk of hemorrhage.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole, diltiazem): may modestly increase plasma levels.
• P‑gp inhibitors (e.g., verapamil): could affect drug transport.
• Certain statins (e.g., simvastatin): monitor for additive hepatic effects.