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 a 100 mg 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.

GNH India supplies Nintedanib Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide, with a focus on quality assurance, regulatory compliance, and reliable global logistics. The company ensures that each batch meets European Union standards for safety and efficacy.

Manufacturer / TM Owner

Sandoz A/S

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Indications & Clinical Uses

Nintedanib is indicated for fibrotic lung diseases 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: helps preserve lung capacity and delay worsening.
  • Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition when used with other agents.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases—including VEGFR, PDGFR, and FGFR—thereby blocking signaling pathways that drive fibroblast proliferation, angiogenesis, and extracellular matrix deposition. This multi‑target inhibition reduces fibrotic remodeling in the lung and, when combined with other anticancer agents, can impede tumor vascularization and growth.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhea: frequent loose stools, often manageable with diet.
  • Abdominal pain: discomfort in the stomach area.
  • Decreased appetite: reduced desire to eat.

Serious or Rare Side Effects

  • Elevated liver enzymes: indicates possible hepatic injury.
  • Bleeding events: increased risk of gastrointestinal or other bleeding.
  • Cardiovascular events: rare cases of heart failure or hypertension exacerbation.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient-specific risk factors and monitor for potential complications.

  • Monitor liver function: obtain baseline and periodic ALT/AST tests.
  • Assess bleeding risk: avoid concomitant use with strong anticoagulants unless necessary.
  • Evaluate cardiovascular status: caution in patients with pre‑existing heart disease.
  • Avoid use in severe hepatic impairment: contraindicated when liver function is markedly compromised.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Nintedanib can interact with other medicines that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib exposure.
  • Concurrent anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding potential.
  • Other antifibrotic agents: additive toxicity risk.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase levels.
  • P‑glycoprotein inhibitors (e.g., verapamil): can affect drug transport.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic effect.

Frequently Asked Questions

Nintedanib Sandoz is prescribed 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 the drug targets pathways that drive fibrosis or tumor growth, helping to slow disease progression and preserve lung function.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting the signaling that leads to fibroblast proliferation, new blood‑vessel formation and extracellular‑matrix deposition. This multi‑target inhibition reduces fibrotic tissue remodeling and can also limit tumor angiogenesis when used with other anticancer agents.

The specific dose and dosing schedule of Nintedanib Sandoz are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and other individual factors. Healthcare professionals follow the approved labeling and adjust the regimen as needed for safety and efficacy.

The safety of Nintedanib in pregnancy and lactation has not been established. It is classified as contraindicated unless the potential benefit justifies the potential risk to the fetus. Women of child‑bearing potential should use effective contraception, and breastfeeding mothers should discuss alternatives with their physician.

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.

Nintedanib differs from other antifibrotics such as pirfenidone by targeting a broader range of tyrosine‑kinase receptors, which may provide additional benefit in certain fibrotic pathways. Clinical trials have shown comparable efficacy in slowing lung‑function decline, but the side‑effect profile and drug‑interaction potential vary, requiring individualized selection by the treating physician.

Nintedanib Sandoz capsules should be stored at ambient temperature, below 25 °C, in the original blister pack or container. Protect the product from moisture and direct sunlight to maintain stability throughout its shelf life.

The medication is supplied as oral capsules and is taken by mouth, usually with food to lessen gastrointestinal discomfort. Patients should swallow the capsule whole with water and follow the dosing instructions provided by their healthcare professional.

Serious risks include significant liver enzyme elevations indicating possible hepatic injury, bleeding complications especially when combined with anticoagulants, and rare cardiovascular events such as heart failure or hypertension exacerbation. Patients should be monitored regularly for these adverse outcomes.

Nintedanib is contraindicated in patients with severe hepatic impairment, those with active bleeding disorders, and individuals taking strong CYP3A4 inhibitors that cannot be discontinued. It should also be avoided in patients who are pregnant unless the benefit outweighs the risk, and in anyone with known hypersensitivity to the drug or its excipients.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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