Nintedanib Zentiva (Nintedanib)

Nintedanib is used to target fibrotic and oncologic pathways in several serious lung conditions.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve pulmonary capacity and delay worsening.
• Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth and angiogenesis.

• 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 fibroblast proliferation, extracellular matrix deposition, and angiogenesis, thereby limiting fibrotic tissue formation and tumor vascular supply.

Nintedanib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may accompany meals.
• Vomiting: occasional expulsion of stomach contents.
• Abdominal pain: discomfort or cramps in the stomach area.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects

• Hepatic failure: signs of severe liver injury such as jaundice.
• Severe bleeding: gastrointestinal or intracranial hemorrhage.
• Cardiovascular events: myocardial infarction or stroke.
• Serious infections: opportunistic or severe bacterial infections.
• Gastrointestinal perforation: sudden severe abdominal pain.
• Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor key parameters.

• Liver function monitoring: check ALT/AST before start and periodically during treatment.
• Cardiovascular assessment: evaluate history of ischemic heart disease or stroke.
• Avoid in severe hepatic impairment: contraindicated when liver function is markedly compromised.
• Pregnancy and lactation: use only if potential benefit outweighs unknown risks.
• Drug‑specific counseling: advise patients to report persistent diarrhea or signs of bleeding.
• Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Nintedanib can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise plasma levels.
• Antacids or proton‑pump inhibitors: could affect absorption, monitor therapeutic response.
• Diuretics: may exacerbate dehydration from diarrhea, watch electrolytes.