Nintedanib Zentiva (Nintedanib)

Nintedanib is used to target fibrotic lung disease pathways and certain oncologic indications.

• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve pulmonary capacity and delays worsening.
• Non‑small cell lung cancer (in selected patients): contributes to disease control when combined with chemotherapy.

• 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 remodeling in lung tissue and limiting tumor‑driven vascular growth. The combined inhibition curtails signaling cascades that drive pathological tissue scarring and tumor neovascularization.

Nintedanib may be associated with a range of adverse reactions, varying from mild to serious.

Common Side Effects

• Diarrhea: frequent loose stools that can be mild to moderate, occasionally severe, possibly leading to dehydration.
• Nausea: persistent feeling of sickness that may reduce appetite and affect oral intake.
• Liver enzyme elevation: mild to moderate increases in ALT/AST, usually asymptomatic but monitored regularly.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury with marked enzyme rise or jaundice, potentially requiring discontinuation.
• Cardiovascular events: serious incidents such as myocardial infarction, stroke, or unstable angina during treatment.
• Bleeding: gastrointestinal or other hemorrhagic episodes, including nosebleeds or blood in urine, needing medical review.

When prescribing Nintedanib, several precautions should be observed to ensure patient safety.

• Liver function monitoring: assess ALT, AST, and bilirubin before starting and periodically during therapy.
• Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea or vomiting.
• Cardiovascular risk assessment: evaluate history of ischemic heart disease before initiating treatment.
• Bleeding risk: avoid concomitant use of strong anticoagulants unless medically necessary.
• Pregnancy and lactation: drug is contraindicated in pregnancy; advise effective contraception and discuss risks if breastfeeding.
• Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.

Nintedanib may interact with other medicines; awareness of major and moderate interactions helps prevent adverse outcomes.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors: may increase nintedanib exposure, raising toxicity risk.
• Anticoagulants (e.g., warfarin): combined use can heighten bleeding potential.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors: may modestly raise drug levels, requiring observation.
• P-glycoprotein substrates: concurrent use can alter nintedanib absorption.
• Antifungal agents (e.g., ketoconazole): may increase plasma concentrations.
• Antihypertensives: monitor blood pressure as nintedanib can affect vascular tone.