Ofev (Nintedanib)

Ofev is approved for conditions that involve progressive lung fibrosis and related pathways.

• Idiopathic Pulmonary Fibrosis (IPF): slows the decline of lung function and reduces disease progression.
• Systemic Sclerosis‑Associated Interstitial Lung Disease (SSc‑ILD): helps to preserve respiratory capacity in affected patients.
• Progressive Fibrosing Interstitial Lung Disease (PF‑ILD): aims to deceler the rate of functional decline in a broader fibrotic lung disease population.

• Nintedanib blocks multiple receptor tyrosine kinases—including vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet‑derived growth factor (PDGF) receptors—thereby inhibiting fibroblast proliferation, migration and extracellular matrix deposition that drive pulmonary fibrosis.

Adverse reactions to Ofev vary in frequency and severity.

Common Side Effects

• Diarrhea: frequent, watery stools often occurring early in therapy.
• Nausea: mild to moderate stomach upset.
• Vomiting: occasional episodes.
• Abdominal pain: cramping or discomfort.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury requiring monitoring.
• Severe gastrointestinal bleeding: uncommon but potentially life‑threatening.
• Cardiovascular events: rare cases of myocardial infarction or stroke.
• Severe infections: opportunistic infections in immunocompromised patients.
• Allergic reactions: rash, pruritus, or anaphylaxis.
• Pulmonary arterial hypertension worsening: rare exacerbation.

When prescribing Ofev, clinicians should consider several safety measures.

• Liver function monitoring: baseline and periodic tests are recommended.
• Gastrointestinal management: advise patients on hydration and antidiarrheal use.
• Bleeding risk assessment: evaluate concomitant anticoagulants or antiplatelet agents.
• Cardiovascular evaluation: screen for history of ischemic heart disease.
• Pregnancy and lactation: avoid use unless benefits outweigh risks.
• Store at below 25°C: keep in the original container, protect from moisture and light.

Ofev may interact with several medicines that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) – may raise nintedanib exposure.
• Anticoagulants (warfarin, direct oral anticoagulants) – heightened bleeding potential.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole) – may modestly increase levels.
• P-glycoprotein substrates (e.g., digoxin) – potential for altered absorption.
• NSAIDs or antiplatelet drugs – may add to gastrointestinal bleeding risk.
• Diuretics – can affect fluid balance and renal function.