Nintedanib Sandoz (Nintedanib)

Nintedanib is indicated for fibrotic lung disorders and as part of combination chemotherapy for certain lung cancers.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delays worsening.
• Non‑small cell lung cancer (in combination with docetaxel): enhances chemotherapy efficacy and may improve survival outcomes.

• Nintedanib inhibits multiple receptor tyrosine kinases, including 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, angiogenesis and extracellular matrix deposition, thereby attenuating fibrotic processes in the lung and limiting tumor‑related vascular growth.

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

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may be accompanied by loss of appetite.
• Vomiting: occasional episodes, usually self‑limiting.
• Decreased appetite: reduced desire to eat, can affect weight.
• Abdominal pain: discomfort or cramping in the stomach area.
• Elevated liver enzymes: mild increases in ALT/AST observed in labs.

Serious or Rare Side Effects

• Hepatic failure: severe liver injury requiring immediate medical attention.
• Severe bleeding: gastrointestinal or intracranial hemorrhage.
• Arterial thromboembolism: clot formation in arteries leading to organ ischemia.
• Gastrointestinal perforation: rare tearing of the intestinal wall.
• Serious infection: opportunistic infections in immunocompromised patients.
• Lung infection: pneumonia or other lower respiratory tract infections.

Before initiating therapy, clinicians should evaluate several safety aspects.

• Renal function: assess baseline creatinine and monitor periodically.
• Hepatic function: check liver enzymes before start and during treatment.
• Bleeding risk: review history of ulcers or anticoagulant use.
• Pregnancy: avoid use unless potential benefit justifies potential fetal risk.
• Drug interactions: review concomitant medications for CYP3A4 substrates.
• Store at ambient temperature: keep in original container, protect from moisture and direct sunlight.

Nintedanib interacts with several drug classes that may alter its safety or efficacy.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure.
• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic levels.
• Anticoagulants (e.g., warfarin): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may modestly raise concentrations.
• Antacids containing aluminum or magnesium: can affect absorption, separate dosing by at least 2 hours.
• P‑glycoprotein inhibitors (e.g., verapamil): may increase plasma levels modestly.