Ofev (Nintedanib)

Nintedanib, the active ingredient in Ofev, is a tyrosine kinase inhibitor presented as a 100 mg or 150 mg hard gelatin capsule for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in appropriate patients.

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

Ofev (nintedanib) is used in fibrotic lung diseases and certain cancers, targeting pathways that drive fibroblast activity and tumor growth.

- Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. - Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and delays worsening of respiratory symptoms. - Non‑small cell lung cancer (in combination therapy): contributes to disease control by inhibiting tumor angiogenesis.

Nintedanib may cause a range of adverse reactions, which are generally categorized by frequency and severity.

Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be transient. - Decreased appetite: reduced desire to eat. - Liver enzyme elevation: mild increase in ALT/AST.

Serious or Rare Side Effects: - Hepatotoxicity: significant liver injury requiring monitoring. - Severe bleeding: gastrointestinal or other hemorrhage. - Cardiovascular events: myocardial infarction or stroke.

Before initiating therapy, clinicians should assess several safety parameters. - Monitor liver function: perform baseline and periodic ALT/AST tests. - Assess bleeding risk: avoid in patients with active ulcers or excessive anticoagulant use. - Evaluate cardiovascular status: caution in patients with recent myocardial infarction. - Pregnancy warning: contraindicated in pregnancy; use effective contraception. - Store below 25°C: keep in the original pack, protect from moisture.

Nintedanib interacts with several drug classes that may alter its exposure or increase adverse events.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., rifampicin): may reduce efficacy. - P‑glycoprotein inhibitors (e.g., verapamil): may modestly increase levels. - NSAIDs or antiplatelet agents: additive bleeding potential.