Ofev (Nintedanib)

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

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

Nintedanib is indicated for fibrotic lung diseases and certain oncologic regimens.

- Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening. - Non‑small cell lung cancer (in combination with docetaxel): enhances overall survival and response rates in previously treated patients.

Nintedanib may be associated with a range of adverse reactions, varying in frequency and severity.

Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may occur early in treatment. - Decreased appetite: reduced desire to eat. - Abdominal pain: mild discomfort in the stomach area.

Serious or Rare Side Effects: - Liver enzyme elevation: increased ALT/AST indicating hepatic stress. - Bleeding events: gastrointestinal or other hemorrhage. - Severe infections: opportunistic or serious bacterial infections.

Before initiating Ofev, several precautions should be considered to ensure safe use.

- Monitor liver function: perform baseline and periodic ALT/AST tests. - Assess bleeding risk: evaluate history of ulcers or anticoagulant use. - Observe gastrointestinal symptoms: manage diarrhea and nausea promptly. - Evaluate cardiovascular status: monitor blood pressure and signs of thromboembolism. - Store at ambient temperature below 25°C: keep capsules in original packaging, protect from moisture.

Nintedanib can interact with other medicines, affecting its exposure or safety profile.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nintedanib levels. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): reduce nintedanib exposure. - Anticoagulants (e.g., warfarin): heightened risk of bleeding.

Moderate Interactions (Monitor Closely): - P‑gp inhibitors (e.g., verapamil): may raise drug concentrations. - P‑gp inducers (e.g., St. John’s wort): may lower drug concentrations. - Other anti‑angiogenic agents (e.g., bevacizumab): potential additive toxicity.