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

Nintedanib Sandoz

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Sandoz (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Sandoz, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease, helping to slow disease progression in adult patients.

GNH India supplies Nintedanib Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established quality‑assurance processes and regulatory compliance across multiple markets. The company ensures consistent batch release and on‑time delivery to meet clinical demand.

Manufacturer / TM Owner

Sandoz A/S

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Indications & Clinical Uses

Nintedanib is an antifibrotic agent that targets key pathways involved in lung fibrosis.

  • Idiopathic pulmonary fibrosis: slows the decline in forced vital capacity and reduces disease progression.
  • Systemic sclerosis‑associated interstitial lung disease: limits further loss of lung function and delays worsening of fibrosis.

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, and transformation, leading to anti‑fibrotic and anti‑angiogenic effects that mitigate the development of scar tissue in the lungs.

Side Effects

Nintedanib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, sometimes accompanied by vomiting.
  • Decreased appetite: reduced desire to eat, may lead to weight loss.
  • Elevated liver enzymes: mild increases in ALT/AST observed in routine labs.

Serious or Rare Side Effects

  • Hepatotoxicity: significant liver injury requiring monitoring and possible discontinuation.
  • Severe bleeding: gastrointestinal or other hemorrhage, especially with anticoagulants.
  • Cardiovascular events: myocardial infarction or stroke in susceptible patients.
  • Interstitial lung disease worsening: acute exacerbation of underlying lung condition.
  • Severe infections: opportunistic infections in immunocompromised individuals.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate several safety considerations.

  • Liver function monitoring: obtain baseline ALT/AST and repeat periodically.
  • Bleeding risk assessment: review concomitant anticoagulants or antiplatelet agents.
  • Pregnancy: avoid use because safety data are lacking; discuss contraception.
  • Drug interactions: assess for strong CYP3A4 inhibitors or inducers that may alter exposure.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Nintedanib can interact with several medication classes, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase plasma concentrations and toxicity.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of serious bleeding.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may modestly raise exposure.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce effectiveness by lowering drug levels.
  • Antacids or proton‑pump inhibitors: could affect absorption; monitor clinical response.

Frequently Asked Questions

Nintedanib Sandoz is an oral antifibrotic medication indicated for adult patients with idiopathic pulmonary fibrosis and for those with systemic sclerosis‑associated interstitial lung disease. In both conditions it is used to slow the decline in lung function and to reduce the progression of fibrotic tissue.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—thereby inhibiting signaling pathways that drive fibroblast proliferation, migration and transformation. This results in reduced formation of scar tissue in the lungs and limits angiogenesis that can contribute to disease progression.

The exact dose and dosing schedule of Nintedanib Sandoz are determined by the prescribing clinician based on the patient’s condition, renal and hepatic function, and concomitant therapies. Healthcare professionals should follow the product label and local prescribing guidelines when initiating therapy.

Safety data for Nintedanib during pregnancy and lactation are limited, and the drug is generally not recommended for use in pregnant or nursing women. Women of childbearing potential should use effective contraception throughout treatment and for a suitable period after discontinuation.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity of Nintedanib Sandoz. 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 agent is pirfenidone, which also slows lung function decline in idiopathic pulmonary fibrosis. Nintedanib targets a broader range of tyrosine kinases, while pirfenidone’s mechanism involves modulation of cytokine production and oxidative stress. Choice between them depends on efficacy, tolerability, drug‑interaction profile and individual patient factors.

Nintedanib tablets should be stored at ambient temperature, below 25 °C, in the original blister pack or container. Protect the product from moisture, excessive heat and direct sunlight. Do not store in the bathroom or near a kitchen sink where humidity is high.

Nintedanib is taken orally, usually twice daily, with food to improve tolerability. The tablets should be swallowed whole with a full glass of water. Patients should not crush, split or chew the tablets, and should follow any additional instructions provided by their healthcare professional.

Serious adverse events include hepatotoxicity (significant liver enzyme elevation or liver injury), severe bleeding (especially when combined with anticoagulants), cardiovascular events such as myocardial infarction or stroke, and acute worsening of interstitial lung disease. Patients should report any signs of liver dysfunction, unusual bleeding, chest pain or sudden respiratory decline immediately.

Nintedanib is contraindicated in patients with known hypersensitivity to the active ingredient or any excipients, in those with severe liver impairment, and in individuals who are pregnant or breastfeeding. Caution is also advised for patients with a history of significant bleeding, uncontrolled cardiovascular disease, or active infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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