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 used to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain types of non‑small cell lung cancer.

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

Manufacturer / TM Owner

Sandoz Hungária Kft

1
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Indications & Clinical Uses

Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways. It is indicated for:

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delays worsening.
  • Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth.

How It Works

  • Nintedanib inhibits the intracellular kinase activity of 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, migration and transformation, and exerts anti‑angiogenic effects that limit fibrotic tissue formation and tumor vascularisation.

Side Effects

Nintedanib may cause a range of adverse reactions. Patients should be informed of the most frequently observed events and the rarer but serious possibilities.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhoea: frequent loose stools.
  • Decreased appetite: reduced desire to eat.
  • Abdominal pain: discomfort in the stomach area.

Serious or Rare Side Effects

  • Severe liver injury: elevated liver enzymes or hepatitis.
  • Major bleeding: gastrointestinal or intracranial hemorrhage.
  • Cardiovascular events: myocardial infarction or stroke.
  • Gastrointestinal perforation: rare but life‑threatening.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Monitor liver function: obtain baseline tests and repeat periodically.
  • Assess cardiovascular risk: review history of ischemic heart disease or stroke.
  • Avoid in severe hepatic impairment: contraindicated when liver function is markedly compromised.
  • Use caution with gastrointestinal disorders: patients with ulcers or inflammatory bowel disease may experience worsening symptoms.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin): heightened risk of bleeding.
  • P‑glycoprotein inhibitors (e.g., itraconazole): raise plasma concentrations.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin): may reduce therapeutic effect.
  • Antiplatelet agents (e.g., aspirin): monitor for additive bleeding risk.
  • Diuretics: potential for dehydration and renal impairment.

Frequently Asked Questions

Nintedanib Sandoz is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer. In each case, it works by inhibiting pathways that drive fibrosis or tumor angiogenesis, helping to slow disease progression.

Nintedanib blocks the activity of several receptor tyrosine kinases, including VEGFR, PDGFR and FGFR. By preventing these signals, the drug reduces fibroblast growth and new blood‑vessel formation, which are key processes in both fibrotic lung disease and tumor development.

The exact dose and dosing schedule are determined by the prescribing clinician based on the specific indication, patient characteristics and any concomitant therapies. Patients should follow the prescriber’s instructions and not alter the regimen without medical advice.

Safety data for nintedanib in pregnancy and lactation are limited, and the product is generally not recommended for use in pregnant or nursing women unless the potential benefit justifies the risk. Women of child‑bearing potential should use effective contraception during treatment.

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 import documentation.

Nintedanib differs from other antifibrotics such as pirfenidone by targeting a broader range of tyrosine kinases, which may provide additional anti‑angiogenic activity. Clinical trials have shown comparable efficacy in slowing lung‑function decline, but the side‑effect profile and drug‑interaction potential vary, influencing choice based on patient tolerance and comorbidities.

Nintedanib Sandoz should be stored at ambient temperature below 25 °C, protected from moisture and light. Keep the product in its original packaging until use, and avoid storing it in bathrooms or other humid environments.

The medication is taken orally, usually as whole tablets swallowed with water. It is typically taken with food to reduce gastrointestinal discomfort, but patients should follow the specific instructions provided by their healthcare professional.

Serious risks include severe liver injury, major bleeding events, cardiovascular complications such as myocardial infarction, and rare gastrointestinal perforations. Patients should be monitored regularly for signs of liver dysfunction, bleeding, and cardiovascular symptoms, and any concerning signs should prompt immediate medical evaluation.

Nintedanib is contraindicated in patients with severe hepatic impairment, uncontrolled bleeding disorders, or known hypersensitivity to the drug. Caution is also advised for individuals with recent cardiovascular events, active gastrointestinal ulcers, or those taking strong CYP3A4 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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