Nintedanib Accordpharma (Nintedanib)

Nintedanib acts on multiple tyrosine‑kinase pathways that drive fibrotic and neoplastic processes.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in forced vital capacity.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve lung function and delay worsening.
• Non‑small cell lung cancer (in combination therapy): contributes to tumor control when combined with other anticancer agents.

• 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 receptors it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic remodeling and tumor‑driven vascular growth.

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: sensation of queasiness, may be transient.
• Vomiting: occasional episodes, usually self‑limited.
• Abdominal pain: cramping or discomfort in the stomach area.
• Decreased appetite: reduced desire to eat, may affect weight.
• Elevated liver enzymes: mild increases in ALT/AST observed in routine labs.

Serious or Rare Side Effects

• Hepatic failure: signs of jaundice, dark urine, or severe fatigue.
• Severe bleeding: gastrointestinal or intracranial hemorrhage, especially with anticoagulants.
• Arterial thromboembolism: sudden chest pain, limb ischemia, or stroke symptoms.
• Gastrointestinal perforation: sudden severe abdominal pain, rigidity, or fever.
• Severe hypertension: markedly elevated blood pressure requiring urgent management.
• Exacerbation of interstitial lung disease: worsening dyspnea or new infiltrates on imaging.

Before initiating therapy, clinicians should evaluate several safety parameters.

• Monitor liver function: obtain baseline ALT/AST and repeat periodically.
• Assess bleeding risk: review use of anticoagulants, antiplatelet agents, or recent surgery.
• Observe for gastrointestinal perforation: educate patients to report severe abdominal pain promptly.
• Check blood pressure regularly: manage hypertension according to guidelines.
• Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

Nintedanib can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Anticoagulants or antiplatelet agents (e.g., warfarin, clopidogrel): heightened risk of serious bleeding.
• Potent P‑gp inhibitors (e.g., verapamil): can raise plasma concentrations.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Co‑administration with other tyrosine‑kinase inhibitors: potential additive toxicity.
• Diuretics: monitor fluid and electrolyte balance, especially in patients with renal impairment.