Nintedanib Stada (Nintedanib)

Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncologic pathways.

• Idiopathic pulmonary fibrosis: slows the decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and delays worsening of respiratory symptoms.
• Non‑small cell lung cancer (with docetaxel): enhances overall response rates and prolongs progression‑free survival when added to 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 fibroblast proliferation, migration, and transformation, and exerts anti‑angiogenic effects that limit fibrotic tissue formation and tumor vascularisation.

Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

• Diarrhea: frequent, often mild to moderate in intensity.
• Nausea and vomiting: may occur early in treatment.
• Decreased appetite: can contribute to weight loss.

Serious or Rare Side Effects

• Elevated liver enzymes or hepatitis: monitor hepatic function regularly.
• Bleeding events: increased risk of gastrointestinal or other hemorrhage.
• Cardiovascular events: includes hypertension and rare myocardial infarction.

Before initiating therapy, clinicians should assess individual risk factors and monitor key parameters.

• Pregnancy: contraindicated; avoid use during pregnancy and advise effective contraception.
• Liver function: obtain baseline tests and repeat periodically; adjust if significant elevation occurs.
• Bleeding risk: evaluate concomitant anticoagulant or antiplatelet therapy.
• Cardiovascular health: monitor blood pressure and cardiac status, especially in patients with pre‑existing disease.
• Drug interactions: review concomitant medications that affect CYP3A4 or P‑glycoprotein.
• Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and light.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effect.
• P‑glycoprotein inhibitors (e.g., verapamil): can raise plasma concentrations.

Moderate Interactions (Monitor Closely)

• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• Antiplatelet agents (e.g., aspirin, clopidogrel): may augment hemorrhagic events.
• Diuretics: monitor electrolytes and renal function due to potential additive effects on fluid balance.