Product image of Nintedanib Teva B.V. (Nintedanib) supplied by GNH India

Nintedanib Teva B.V.

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Teva B.V. (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Teva B.V., is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used in combination therapy for non‑small cell lung cancer.

GNH India supplies Nintedanib Teva B.V. as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Teva B.V

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Indications & Clinical Uses

  • Nintedanib acts on multiple fibrotic and oncogenic pathways, providing therapeutic benefit in several lung‑related conditions.
  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delay worsening.
  • Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition when used with other anticancer agents.

How It Works

  • Nintedanib inhibits a spectrum of 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 blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic remodeling and tumor‑driven vascular growth.

Side Effects

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

Common Side Effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain
  • Decreased appetite
  • Elevated liver enzymes (ALT/AST)

Serious or Rare Side Effects

  • Hepatic failure or severe liver injury
  • Arterial thromboembolic events (e.g., myocardial infarction, stroke)
  • Severe bleeding or hemorrhage
  • Gastrointestinal perforation
  • Severe hypertension
  • Exacerbation of interstitial lung disease

Precautions & Warnings

  • Before initiating therapy, clinicians should evaluate several safety parameters.
  • Monitor liver function: perform baseline and periodic hepatic enzyme tests.
  • Assess cardiovascular risk: review history of thromboembolic disease.
  • Evaluate bleeding risk: avoid concurrent use with strong anticoagulants unless necessary.
  • Use caution in renal impairment: adjust monitoring for patients with reduced kidney function.
  • Pregnancy and lactation: avoid use as safety data are lacking.
  • Store at below 25°C: keep in the original packaging, protect from moisture and light.

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)
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants)
  • Antiplatelet agents (e.g., clopidogrel, high‑dose aspirin)
  • Concurrent use with other tyrosine‑kinase inhibitors
  • High‑dose aspirin (>100 mg daily)

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole)
  • P‑gp inhibitors (e.g., verapamil)
  • Diuretics (may increase risk of dehydration)
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs)
  • CYP3A4 inducers (e.g., rifampicin) which may reduce exposure

Frequently Asked Questions

Nintedanib Teva B.V. 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 each case, it works to slow disease progression by targeting pathways involved in fibrosis and tumor growth.

The drug blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby reducing fibroblast activation, angiogenesis and extracellular matrix formation. This inhibition curtails the fibrotic process in the lungs and can also limit tumor‑driven vascular development when used with other anticancer agents.

The prescribed dose of Nintedanib is determined by the treating physician based on the specific indication, patient characteristics and tolerability. Dosage regimens are not standardized in public literature and should always follow the prescriber’s instructions.

Safety data for Nintedanib in pregnancy and lactation are insufficient, and the product is classified as having an unknown pregnancy category. It is generally avoided in pregnant or nursing women unless the potential benefit outweighs the potential risk, as decided by a qualified healthcare professional.

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 requirements) and the necessary 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‑kinase receptors, which may provide additional benefit in systemic sclerosis‑associated lung disease and certain cancer regimens. Safety profiles differ, with Nintedanib more frequently causing gastrointestinal side effects and pirfenidone associated with photosensitivity.

Nintedanib should be stored at temperatures below 25 °C, in its original packaging to protect it from moisture and light. Keep the product in a dry place and avoid exposure to excessive heat or humidity to maintain its stability throughout its shelf life.

The medication is taken orally, usually as a tablet, with food or a light meal to reduce gastrointestinal irritation. Patients should swallow the tablet whole with water and follow the dosing schedule prescribed by their healthcare provider.

Serious adverse events include severe liver injury, arterial thromboembolic events such as heart attack or stroke, major bleeding, gastrointestinal perforation, and significant hypertension. Patients should be monitored regularly for signs of these conditions, and therapy should be discontinued if any serious reaction occurs.

Nintedanib is contraindicated in patients with severe hepatic impairment, active bleeding disorders, recent major cardiovascular events, and in women who are pregnant or may become pregnant without effective contraception. It should also be used with caution in individuals with moderate renal impairment or a history of gastrointestinal ulcers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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