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 formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and certain forms of lung cancer, acting to slow disease progression and inhibit tumor‑related pathways.

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

  • Nintedanib is employed in fibrotic lung disease and oncologic indications where inhibition of multiple growth factor receptors is required.
  • Idiopathic pulmonary fibrosis: reduces the rate of decline in lung function and delays disease progression.
  • Non‑small cell lung cancer: used in combination regimens to impede tumor growth and angiogenesis.
  • Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and slows fibrotic change.

How It Works

  • Nintedanib blocks the intracellular kinase activity of several 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 angiogenesis, fibroblast proliferation, and extracellular matrix deposition that drive fibrosis and tumor vascularization.

Side Effects

Adverse reactions vary in frequency and severity.

Common Side Effects

  • Diarrhea: frequent, watery stools.
  • Nausea: mild to moderate upset stomach.
  • Vomiting: occasional episodes.
  • Abdominal pain: cramping or discomfort.
  • Decreased appetite: reduced food intake.
  • Elevated liver enzymes: increased ALT/AST.

Serious or Rare Side Effects

  • Severe liver injury: jaundice, hepatitis.
  • Major bleeding: gastrointestinal or intracranial hemorrhage.
  • Cardiovascular events: myocardial infarction, stroke.
  • Gastrointestinal perforation: severe abdominal pain.
  • Severe infections: opportunistic bacterial or fungal infections.
  • Skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline organ function and risk factors.

  • Liver monitoring: perform baseline and periodic liver function tests.
  • Cardiovascular assessment: evaluate history of ischemic heart disease.
  • Bleeding risk: review concomitant anticoagulant or antiplatelet use.
  • Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
  • Hepatic impairment: consider dose adjustment or heightened monitoring.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Nintedanib may interact with drugs that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels.
  • Potent P‑glycoprotein inhibitors (e.g., verapamil): increase exposure.
  • Anticoagulants (warfarin, direct oral anticoagulants): heightened bleeding tendency.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Antacids containing aluminum or magnesium: could affect absorption.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): monitor for additive bleeding risk.
  • Herbal supplements (St. John’s wort): may lower drug concentrations.

Frequently Asked Questions

Nipfilan, whose active ingredient is nintedanib, is prescribed for idiopathic pulmonary fibrosis, non‑small cell lung cancer, and systemic sclerosis‑associated interstitial lung disease. In each case the drug works by inhibiting pathways that drive fibrosis or tumor growth, helping to slow disease progression.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby reducing angiogenesis, fibroblast activation, and extracellular matrix formation. This multi‑target inhibition curtails the processes that lead to lung scarring and supports anti‑tumor activity in certain cancers.

The specific dose and dosing schedule for Nipfilan are determined by the prescribing physician based on the patient’s condition, weight, organ function and concomitant therapies. Healthcare providers tailor the regimen to achieve optimal therapeutic benefit while minimizing risk.

Safety data for nintedanib in pregnancy and lactation are limited. It is generally advised to avoid use unless the potential benefit to the mother clearly outweighs any possible risk to the fetus or infant. Women of child‑bearing potential should discuss contraception with their doctor.

To request Nipfilan, 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 and any necessary import documentation.

Compared with pirfenidone, another antifibrotic approved for idiopathic pulmonary fibrosis, nintedanib targets a broader range of tyrosine kinases, which may offer additional benefit in certain patients but also carries a distinct safety profile, including a higher incidence of gastrointestinal side effects.

Nipfilan should be stored at temperatures below 25 °C, in its original container, protected from moisture and direct sunlight. Maintaining these conditions helps preserve the tablet’s stability and potency throughout its shelf life.

Nipfilan is taken orally, usually with food to lessen gastrointestinal discomfort. The tablets are swallowed whole with a full glass of water and should be taken at the same time each day as directed by the prescriber.

The most serious adverse events linked to nintedanib include severe liver injury, major bleeding, cardiovascular events such as myocardial infarction or stroke, and rare but life‑threatening skin reactions. Patients should be monitored regularly for signs of these conditions.

Nipfilan is contraindicated in patients with known hypersensitivity to nintedanib or any excipients, those with severe hepatic impairment, and individuals with active bleeding disorders. Caution is also advised for patients with uncontrolled cardiovascular disease or pregnant women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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