Product image of Nipfilan (Nintedanib) supplied by GNH India

Nipfilan

Active Ingredient:
Nintedanib
Origin:
EU

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

Manufacturer / TM Owner

G.L. Pharma Gmbh

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Indications & Clinical Uses

  • 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.

How It Works

  • Nintedanib blocks the intracellular kinase activity of 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, angiogenesis, and extracellular matrix deposition, thereby limiting fibrotic tissue formation and tumor vascularization.

Side Effects

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.

Precautions & Warnings

  • 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.

Avoid Interactions

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.

Frequently Asked Questions

Nipfilan (nintedanib) is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer where inhibition of multiple growth factor receptors is part of the therapeutic strategy.

Nintedanib blocks the kinase activity of VEGFR, PDGFR and FGFR receptors. This inhibition reduces fibroblast proliferation, angiogenesis and extracellular matrix production, thereby limiting fibrosis and tumor‑related blood vessel formation.

The dosage of Nipfilan is individualized by the prescribing clinician based on the specific indication, patient characteristics and tolerability. Exact dosing regimens are not disclosed here and should follow the prescriber’s instructions.

Safety data for nintedanib in pregnancy and lactation are limited. It is generally advised to avoid use unless the potential benefit justifies the risk. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs) and required import documentation.

The primary alternative for idiopathic pulmonary fibrosis is pirfenidone, another antifibrotic agent. While both slow disease progression, nintedanib targets a broader range of tyrosine kinases, which may offer additional benefit in systemic sclerosis‑related lung disease and certain lung cancers. Choice depends on efficacy, tolerability, drug‑interaction profile and physician judgment.

Nipfilan should be stored at ambient temperature, below 25 °C. Keep the tablets in the original blister pack, protect them from moisture and direct sunlight, and ensure the container is tightly closed when not in use.

Nipfilan is taken orally, usually twice daily with food. Tablets should be swallowed whole with a full glass of water and not crushed, chewed, or split unless specifically instructed by a healthcare professional.

Serious adverse events include hepatic failure, severe bleeding, cardiovascular complications such as myocardial infarction or stroke, gastrointestinal perforation, serious infections, and worsening of interstitial lung disease. Patients should be monitored closely for signs of these conditions and seek immediate medical attention if they occur.

Nipfilan is contraindicated in patients with severe hepatic impairment, uncontrolled bleeding disorders, recent major cardiovascular events, and in women who are pregnant or may become pregnant without appropriate contraception. It should also be avoided in individuals with known hypersensitivity to nintedanib or any excipients in the formulation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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