Nintedanib Wockhardt Uk (Nintedanib)

Nintedanib is an antifibrotic agent used in progressive fibrosing lung disorders.

• Idiopathic pulmonary fibrosis: slows decline in forced vital capacity and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves lung function decline and stabilises disease activity.
• Other progressive fibrosing interstitial lung diseases: may reduce rate of lung function loss in eligible patients.

• 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 the progression of pulmonary fibrosis.

Nintedanib may cause a range of adverse reactions, from mild to serious.

Common Side Effects

• Diarrhoea: frequent loose stools, often mild to moderate.
• Nausea: feeling of stomach upset, may occur early in therapy.
• Vomiting: occasional episodes, usually self‑limiting.
• Abdominal pain: cramping or discomfort in the stomach area.
• Decreased appetite: reduced desire to eat, can affect nutritional intake.
• Weight loss: unintended loss of body weight over time.

Serious or Rare Side Effects

• Elevated liver enzymes: significant increase in ALT/AST indicating hepatic stress.
• Bleeding events: gastrointestinal or other bleeding, especially when combined with anticoagulants.
• Cardiovascular events: hypertension or arterial thrombotic events.
• Severe infections: opportunistic infections in immunocompromised patients.
• Gastrointestinal perforation: rare but potentially life‑threatening ulceration.

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

• Liver monitoring: check ALT/AST before start and periodically during treatment.
• Bleeding risk: evaluate concomitant anticoagulant or antiplatelet use and monitor for signs of hemorrhage.
• Cardiovascular assessment: review history of hypertension, ischemic heart disease, and manage accordingly.
• Gastrointestinal symptoms: advise patients to report persistent diarrhoea or abdominal pain promptly.
• Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks.
• Store at room temperature: keep in 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.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• P‑gp inhibitors (e.g., verapamil, amiodarone): can raise plasma concentrations.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• NSAIDs and aspirin: additive risk of gastrointestinal bleeding.
• Diuretics: monitor for dehydration that could exacerbate renal side effects.