Nintedanib Sandoz (Nintedanib)

Nintedanib is indicated for fibrotic lung disorders and certain oncologic regimens, targeting disease processes that involve abnormal fibroblast activity and angiogenesis.

• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening.
• Non‑small cell lung cancer (in combination with docetaxel): enhances response rate and overall survival in previously treated patients.

• Nintedanib inhibits multiple receptor tyrosine kinases—including VEGFR, PDGFR and FGFR—as well as non‑receptor kinases. By blocking these pathways it reduces fibroblast proliferation, migration and transformation, and suppresses angiogenesis, thereby limiting fibrotic tissue formation and tumor vascular supply.

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 and vomiting: gastrointestinal discomfort that may affect intake.
• Decreased appetite: reduced desire to eat, potentially leading to weight loss.
• Abdominal pain: cramping or discomfort in the stomach area.
• Elevated liver enzymes: mild increases in ALT/AST observed in routine labs.

Serious or Rare Side Effects

• Severe liver injury: hepatitis or hepatic failure requiring monitoring.
• Gastrointestinal perforation: rare but potentially life‑threatening ulceration.
• Bleeding events: increased risk of hemorrhage, especially with anticoagulants.
• Arterial thromboembolism: rare clot formation in arteries.
• Severe hypersensitivity reactions: rash, angioedema or anaphylaxis.

Before initiating therapy, clinicians should assess baseline organ function and comorbidities.

• Liver monitoring: perform baseline and periodic liver function tests.
• Cardiovascular risk: evaluate for history of ischemic heart disease or uncontrolled hypertension.
• Bleeding risk: use caution in patients on anticoagulants or with bleeding disorders.
• Gastrointestinal health: avoid in patients with active ulcers or recent GI surgery.
• Store below 25°C: keep in the original pack, protect from moisture.

Nintedanib may interact with other medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampin): may decrease nintedanib levels.
• Anticoagulants (e.g., warfarin): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

• P‑gp inhibitors (e.g., verapamil): may modestly raise plasma concentrations.
• NSAIDs or antiplatelet agents: may add to bleeding risk.