Ofev (Nintedanib)

Nintedanib, the active ingredient in Ofev, is a tyrosine kinase inhibitor presented as a 150 mg capsule for oral use. It treats fibrotic lung diseases such as idiopathic pulmonary fibrosis and is indicated for use in adults.

GNH USA supplies Ofev as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

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.

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.