Product image of Nintedanib 1a Pharma (Nintedanib Esylate) supplied by GNH India

Nintedanib 1a Pharma

Active Ingredient:
Nintedanib Esylate
Origin:
EU

Nintedanib 1a Pharma (Nintedanib Esylate)

Nintedanib, the active ingredient in Nintedanib 1a Pharma, is a tyrosine kinase inhibitor presented as a oral capsule 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 in appropriate patients.

GNH India supplies Nintedanib 1a Pharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide.

Manufacturer / TM Owner

1 A Pharma Gmbh

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Indications & Clinical Uses

Nintedanib is indicated for fibrotic lung conditions and as part of combination therapy for certain lung cancers.

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilizes lung involvement.
  • Non‑small cell lung cancer (in combination therapy): enhances treatment efficacy when used with chemotherapy agents.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), fibroblast growth factor receptors (FGFR 1‑3), and platelet‑derived growth factor receptors (PDGFR‑α/β). By blocking these pathways, it reduces fibroblast proliferation, migration, transformation and angiogenesis, thereby limiting fibrotic tissue formation and tumor‑associated vascular growth.

Side Effects

Nintedanib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may be transient.
  • Vomiting: occasional episodes, usually self‑limiting.
  • Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, requires monitoring.
  • Cardiovascular events: arterial thromboembolism or myocardial infarction.
  • Severe bleeding: gastrointestinal or other major hemorrhage.

Precautions & Warnings

When prescribing Nintedanib, clinicians should consider several safety and handling precautions.

  • Liver function monitoring: assess ALT, AST, bilirubin before and during therapy.
  • Gastrointestinal assessment: monitor for persistent diarrhea or vomiting.
  • Cardiovascular risk: evaluate history of arterial thromboembolism.
  • Pregnancy and lactation: avoid use due to unknown safety; contraindicated in pregnancy.
  • Drug interactions: review concomitant medications that affect CYP3A4.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.

Avoid Interactions

Nintedanib can interact with other medicines, influencing its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may markedly reduce plasma levels.
  • Anticoagulants (warfarin, direct oral anticoagulants): increased bleeding risk.
  • Antiplatelet agents (aspirin, clopidogrel): heightened hemorrhage potential.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may raise exposure.
  • P-glycoprotein inhibitors (e.g., verapamil): possible increase in concentration.
  • Diuretics: monitor for dehydration if severe diarrhea occurs.

Frequently Asked Questions

Nintedanib 1a Pharma is approved for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer. In each indication it aims to slow disease progression, preserve lung function, or improve the effectiveness of chemotherapy.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—preventing downstream signaling that drives fibroblast activation, angiogenesis and tissue remodeling. By inhibiting these pathways, it reduces the formation of fibrotic tissue and can limit tumor‑related vascular growth.

The exact dose of Nintedanib is set by the prescribing clinician based on the approved indication, patient weight, renal and hepatic function, and any concomitant medications. Dosing recommendations are provided in the product labeling, but the final regimen is individualized by the treating physician.

Safety of Nintedanib in pregnancy and lactation has not been established. The product is classified as contraindicated in pregnancy because potential fetal harm cannot be ruled out, and breastfeeding is not recommended while receiving therapy.

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 and any necessary import documentation.

The primary alternative antifibrotic is pirfenidone. Both agents slow disease progression in idiopathic pulmonary fibrosis, but they differ in target pathways—pirfenidone modulates cytokine production while Nintedanib blocks multiple tyrosine kinases. Their safety profiles also vary; for example, Nintedanib is more frequently associated with diarrhea, whereas pirfenidone often causes photosensitivity.

Nintedanib oral capsules should be stored at ambient temperature, preferably below 25 °C (77 °F). Keep them in the original blister pack, protect from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability.

Nintedanib is taken orally as a capsule, usually with food to reduce gastrointestinal discomfort. The capsule is swallowed whole with a glass of water and should not be crushed, chewed, or opened. Administration timing follows the dosing schedule prescribed by the treating physician.

Serious risks include liver injury (hepatotoxicity), cardiovascular events such as arterial thromboembolism or myocardial infarction, and severe bleeding. Patients should be monitored regularly for liver enzyme elevations, signs of cardiovascular compromise, and any unexpected hemorrhagic symptoms.

Nintedanib is contraindicated in patients with known hypersensitivity to the drug or its excipients, in pregnant women, and in individuals with severe hepatic impairment. Caution is also advised for patients with a history of significant cardiovascular disease, active bleeding, or uncontrolled gastrointestinal disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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