Nintedanib Teva (Nintedanib)

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

• Idiopathic pulmonary fibrosis: slows disease progression and reduces the rate of forced vital capacity decline.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and stabilises fibrotic changes.
• Non‑small cell lung cancer: used in combination regimens to inhibit tumour growth and angiogenesis, contributing to disease control.

• 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, migration, and transformation, thereby limiting extracellular matrix deposition and angiogenesis that drive fibrosis and tumor growth. The inhibition is dose‑dependent and results in decreased signaling that underlies pathological tissue remodeling.

Nintedanib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness that may reduce appetite.
• Vomiting: occasional episodes, usually self‑limiting.
• Abdominal pain: discomfort in the stomach area.
• Decreased appetite: reduced desire to eat, potentially leading to weight loss.

Serious or Rare Side Effects

• Elevated liver enzymes: indicates potential hepatic injury and requires monitoring.
• Bleeding events: increased risk of gastrointestinal or other hemorrhage.
• Cardiovascular events: such as myocardial infarction or stroke.
• Gastrointestinal perforation: rare but serious intestinal injury.

When prescribing Nintedanib, clinicians should observe several safety considerations to minimise risk.

• Liver function monitoring: assess baseline enzymes and repeat regularly during therapy.
• Bleeding risk assessment: evaluate concomitant anticoagulant use and history of haemorrhage.
• Cardiovascular evaluation: screen for recent myocardial infarction or uncontrolled hypertension.
• Pregnancy and lactation: avoid use as safety data are insufficient; discontinue if pregnancy occurs.
• Drug interactions: review concomitant medicines that affect CYP3A4 or P‑gp pathways.
• Renal function: monitor in patients with severe impairment.
• Store at below 25°C: keep in the original packaging, protect from moisture and light.

Nintedanib can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase exposure and toxicity.
• Potent P‑glycoprotein inhibitors (e.g., verapamil): can raise plasma concentrations.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• Antiplatelet agents (e.g., aspirin, clopidogrel): may exacerbate haemorrhagic events.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly increase levels.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Antacids or proton‑pump inhibitors: could affect absorption, monitor therapeutic response.
• Diuretics: may increase risk of dehydration, monitor electrolytes.