Nipfilan (Nintedanib)

Nintedanib, the active ingredient in Nipfilan, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease and certain non‑small cell lung cancers.

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

Nipfilan is indicated for fibrotic lung diseases and selected lung cancer where inhibition of multiple growth factor receptors is required.

Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in forced vital capacity. Systemic sclerosis‑associated interstitial lung disease: improves lung function and delays worsening. Non‑small cell lung cancer (with specific molecular profiles): contributes to tumor growth inhibition as part of combination therapy.

Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects: - Diarrhoea: frequent, often mild to moderate. - Nausea and vomiting: may occur early in treatment. - Decreased appetite: can lead to weight loss. - Abdominal pain: intermittent discomfort. - Elevated liver enzymes (ALT/AST): usually reversible. - Fatigue: generalized tiredness.

Serious or Rare Side Effects: - Hepatic failure: rare but may be life‑threatening. - Severe bleeding: especially when combined with anticoagulants. - Cardiovascular events: myocardial infarction or stroke. - Gastrointestinal perforation: rare but serious. - Severe infections: opportunistic pathogens. - Exacerbation of interstitial lung disease: may worsen respiratory status.

Before initiating therapy, clinicians should assess baseline organ function and consider potential risks.

Liver function monitoring: obtain baseline ALT/AST and repeat periodically. Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use. Cardiovascular evaluation: screen for history of ischemic heart disease. Pregnancy and lactation: avoid use unless benefits outweigh risks. Drug interaction review: check for CYP3A4 inhibitors or inducers. Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture and light.

Nintedanib may interact with several drug classes, requiring careful management.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nintedanib exposure. - Potent P‑glycoprotein inhibitors (e.g., verapamil): raise plasma concentrations. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): elevate bleeding risk.

Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): reduce therapeutic levels. - Antacids containing aluminium or magnesium: may affect absorption; separate dosing by at least 2 hours. - Diuretics: monitor fluid and electrolyte balance due to potential additive gastrointestinal effects.