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 unknown/unknown 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 Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide.

Manufacturer / TM Owner

Sandoz Farmacéutica, S.A.

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Indications & Clinical Uses

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

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

How It Works

  • Nintedanib blocks multiple receptor tyrosine kinases, notably VEGFR 1‑3, PDGFR‑α/β and FGFR 1‑3. Inhibition of these pathways reduces endothelial cell proliferation, fibroblast activation and angiogenesis, thereby limiting fibrotic tissue formation and tumor vascular support.

Side Effects

Nintedanib may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may be transient.
  • Elevated liver enzymes: mild increases in ALT/AST.
  • Decreased appetite: reduced desire to eat.

Serious or Rare Side Effects

  • Hepatotoxicity: significant liver injury indicated by marked enzyme rise.
  • Bleeding events: gastrointestinal or other hemorrhage.
  • Severe infections: opportunistic infections that may require medical attention.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor relevant parameters.

  • Renal function: assess baseline and monitor during therapy.
  • Hepatic function: avoid in patients with severe liver impairment; monitor enzymes regularly.
  • Bleeding risk: use caution in patients receiving anticoagulants or antiplatelet agents.
  • Pregnancy and lactation: safety not established; avoid unless benefits outweigh risks.
  • Drug interactions: review concomitant medications for CYP3A4 substrates and P‑gp inhibitors.
  • Store at ambient temperature: keep below 25 °C, retain original packaging, protect from moisture.

Avoid Interactions

Nintedanib can interact with several drug classes; careful review is required.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may markedly reduce nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): increase risk of bleeding.
  • Potent P‑glycoprotein inhibitors (e.g., itraconazole): may raise plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly increase exposure.
  • Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for bleeding tendencies.
  • Diuretics: watch for dehydration that could affect drug absorption.

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 aims to slow disease progression by targeting pathways involved in fibrosis and tumor angiogenesis.

Nintedanib inhibits several receptor tyrosine kinases, including VEGFR, PDGFR and FGFR. By blocking these signals it reduces fibroblast proliferation, angiogenesis and the formation of fibrotic tissue, which helps preserve lung function and can limit tumor blood supply when used with chemotherapy.

The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and other individual factors. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for nintedanib in pregnancy and lactation are limited. It is generally advised to avoid use unless the potential benefit to the mother clearly outweighs any possible risk to the fetus or infant. 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 and any necessary import documentation.

Nintedanib differs from other antifibrotics such as pirfenidone by targeting a broader range of tyrosine kinases (VEGFR, PDGFR, FGFR). This multi‑target approach may offer benefits in certain fibrotic lung diseases and in combination cancer regimens, though individual response and tolerability vary.

Nintedanib Sandoz should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed when not in use.

The medication is taken orally, usually as a tablet or capsule, with water. It is commonly taken twice daily with food to reduce gastrointestinal discomfort, but patients should follow the exact instructions provided by their healthcare professional.

Serious adverse events include hepatotoxicity (significant liver injury), severe bleeding, and opportunistic infections. Patients should be monitored regularly for liver enzyme elevations, signs of bleeding, and any unusual infections, and they should report these promptly to their physician.

Nintedanib is contraindicated in patients with severe hepatic impairment, active bleeding disorders, or those receiving strong CYP3A4 inducers that would markedly reduce drug exposure. Caution is also advised for individuals with moderate renal impairment or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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