Nintedanibesilat Stada D.O.O. (Nintedanib)

Nintedanib is an antifibrotic agent that targets pathways involved in lung fibrosis.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: mitigates fibrotic changes and helps preserve respiratory capacity.
• Progressive fibrosing interstitial lung disease (when approved): may delay worsening of lung function.

• 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 differentiation, thereby limiting extracellular matrix deposition and the development of fibrosis in lung tissue.

Nintedanib may cause a range of adverse reactions, most of which are manageable with monitoring and supportive care.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: sensation of unease or urge to vomit.
• Vomiting: occasional expulsion of stomach contents.
• Abdominal pain: discomfort or cramps in the stomach area.
• Decreased appetite: reduced desire to eat.
• Weight loss: unintended loss of body weight.

Serious or Rare Side Effects

• Elevated liver enzymes: may indicate hepatic injury.
• Bleeding events: increased risk of gastrointestinal or other bleeding.
• Cardiovascular events: rare cases of myocardial infarction or stroke.
• Severe infections: opportunistic infections in immunocompromised patients.
• Gastrointestinal perforation: rare but serious tearing of the GI tract.
• Severe skin reactions: such as Stevens‑Johnson syndrome.

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

• Liver monitoring: perform baseline and periodic liver function tests.
• Bleeding risk: evaluate concomitant anticoagulant or antiplatelet use.
• Cardiovascular assessment: review history of heart disease or stroke.
• Gastrointestinal management: advise patients to stay hydrated and report persistent diarrhea.
• Pregnancy and lactation: avoid use in pregnancy; safety in breastfeeding is unknown.
• Store at room temperature: keep in original container, protect from moisture and direct sunlight.

Nintedanib can interact with several drug classes; careful review of a patient’s medication list is essential.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• Antiplatelet agents (e.g., aspirin, clopidogrel): additive bleeding potential.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise drug levels.
• P‑glycoprotein inhibitors (e.g., verapamil): could affect absorption.
• Diuretics: monitor for dehydration if gastrointestinal losses occur.