Product image of Nintedanib Eurogenerics (Nintedanib) supplied by GNH India

Nintedanib Eurogenerics

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Eurogenerics (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Eurogenerics, is a tyrosine kinase inhibitor presented as a 100 mg capsule for oral use. It is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer in appropriate patients.\n\nGNH India supplies Nintedanib Eurogenerics as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, providing consistent quality and regulatory compliance.

Manufacturer / TM Owner

Eurogenerics N.V./S.A.

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Indications & Clinical Uses

  • Nintedanib is approved for fibrotic lung diseases and as an adjunct in certain lung cancer treatment regimens.\n\n- Idiopathic pulmonary fibrosis: slows disease progression and reduces the rate of decline in forced vital capacity, helping preserve lung function.\n- Systemic sclerosis‑associated interstitial lung disease: improves pulmonary outcomes by limiting fibrosis and maintaining respiratory capacity in affected patients.\n- Non‑small cell lung cancer (in combination therapy): contributes to tumor control when combined with chemotherapy agents, extending progression‑free survival in eligible patients.

How It Works

  • Nintedanib blocks the intracellular kinase activity of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), platelet‑derived growth factor receptors (PDGFR‑α/β) and fibroblast growth factor receptors (FGFR 1‑3). By inhibiting these pathways, it reduces fibroblast proliferation, extracellular matrix deposition and pathological angiogenesis that drive pulmonary fibrosis and tumor growth. It also modulates downstream signaling cascades that contribute to inflammatory responses.

Side Effects

  • Nintedanib may cause a range of adverse reactions, which are categorized by frequency and severity.\n\nCommon Side Effects:\n- Nausea: frequent gastrointestinal upset.\n- Diarrhea: often watery and may lead to dehydration.\n- Vomiting: occasional episodes of stomach emptying.\n- Decreased appetite: reduced desire to eat.\n- Abdominal pain: mild to moderate discomfort.\n- Weight loss: unintended loss of body weight.\n\nSerious or Rare Side Effects:\n- Elevated liver enzymes (ALT/AST): indicates potential liver injury.\n- Hepatitis or liver failure: rare but severe hepatic toxicity.\n- Severe bleeding events: increased risk of hemorrhage.\n- Cardiovascular complications (e.g., myocardial infarction): rare heart events.\n- Gastrointestinal perforation: rare but serious intestinal injury.\n- Severe skin reactions (e.g., Stevens‑Johnson syndrome): life‑threatening dermatologic response.

Precautions & Warnings

  • When prescribing Nintedanib, clinicians should observe several precautionary measures to minimize risks and ensure safe use.\n- Monitor liver function: perform baseline and periodic ALT/AST testing.\n- Assess bleeding risk: evaluate concomitant anticoagulant or antiplatelet therapy.\n- Evaluate cardiovascular status: consider history of ischemic heart disease.\n- Review concomitant medications: avoid strong CYP3A4 inhibitors and adjust doses as needed.\n- Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

  • Nintedanib can interact with other medicines, affecting its efficacy or safety profile.\n\nMajor Interactions (Avoid):\n- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase Nintedanib exposure.\n- Anticoagulants (e.g., warfarin): heightened risk of bleeding.\n- P‑gp inhibitors (e.g., verapamil): can raise plasma concentrations.\n\nModerate Interactions (Monitor Closely):\n- CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce drug levels.\n- Antiplatelet agents (e.g.,

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GNH India Pharmaceuticals Limited

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