Nintedanib Teva Uk (Nintedanib)

Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways, providing disease‑modifying benefits in several lung conditions.

• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and delays respiratory deterioration.
• Non‑small cell lung cancer (in combination therapy): enhances progression‑free survival when added to standard chemotherapy regimens.

• 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 angiogenesis, fibroblast proliferation, and extracellular matrix deposition, resulting in anti‑angiogenic and anti‑fibrotic effects that modify disease progression in fibrotic lung disorders and certain cancers.

Adverse reactions may vary in frequency and severity. Patients should be monitored regularly for any new or worsening symptoms.

Common Side Effects

• Diarrhoea: frequent loose stools, often mild to moderate.
• Nausea: sensation of unease or urge to vomit.
• Abdominal pain: discomfort in the stomach region.
• Decreased appetite: reduced desire to eat.
• Vomiting: expulsion of stomach contents.
• Elevated liver enzymes: increased ALT/AST on laboratory tests.

Serious or Rare Side Effects

• Hepatic failure: severe liver injury requiring medical attention.
• Major bleeding: gastrointestinal or intracranial hemorrhage.
• Arterial thromboembolism: clot formation in arteries.
• Gastrointestinal perforation: hole in the wall of the stomach or intestines.
• Severe hypertension: dangerously high blood pressure.
• Exacerbation of interstitial lung disease: rapid worsening of lung function.

Before initiating therapy, clinicians should assess baseline organ function and counsel patients on potential risks.

• Liver monitoring: perform baseline and periodic liver function tests.
• Bleeding risk: evaluate for anticoagulant use or active bleeding.
• Cardiovascular assessment: check blood pressure and history of thrombotic events.
• Hepatic impairment: avoid or adjust dose in severe liver disease.
• Pregnancy and lactation: safety unknown; avoid use unless benefits outweigh risks.
• Store at below 25°C: 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 risk of serious bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel): augment bleeding potential.
• P‑gp inhibitors (e.g., verapamil): elevate plasma concentrations.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Moderate CYP inhibitors (e.g., fluconazole): require observation of liver enzymes.
• Non‑steroidal anti‑inflammatory drugs (NSAIDs): add to gastrointestinal bleeding risk.
• Diuretics: monitor electrolytes and renal function.