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

Nintedanib Stada

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Stada (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It treats idiopathic pulmonary fibrosis and non‑small cell lung cancer in patients for whom these conditions are indicated.

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

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

  • Nintedanib is indicated for diseases driven by fibroblast proliferation and tumor angiogenesis.
  • Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function.
  • Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth and angiogenesis.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases, including VEGFR 1‑3, FGFR 1‑3, and PDGFR α/β. By blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and tumor cell growth, thereby exerting antifibrotic and antineoplastic effects.

Side Effects

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

Common Side Effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain
  • Decreased appetite
  • Elevated liver enzymes (ALT/AST)

Serious or Rare Side Effects

  • Hepatic failure
  • Severe bleeding events
  • Arterial thromboembolism
  • Gastrointestinal perforation
  • Severe hypertension
  • Interstitial lung disease

Precautions & Warnings

  • Before initiating therapy, clinicians should assess several safety aspects.
  • Monitor liver function: perform baseline and periodic hepatic enzyme tests.
  • Assess cardiovascular risk: evaluate history of thromboembolic disease.
  • Evaluate bleeding risk: caution in patients on anticoagulants.
  • Avoid in severe hepatic impairment: contraindicated when liver function is markedly compromised.
  • Pregnancy and lactation: safety unknown; avoid use unless benefit outweighs risk.
  • Store at below 25°C: keep in the original packaging, protect from moisture and light.

Avoid Interactions

Nintedanib interacts with several drug classes that may alter its exposure or increase toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase nintedanib plasma levels.
  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): markedly reduce nintedanib exposure.
  • Anticoagulants (e.g., warfarin): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise exposure.
  • Moderate CYP3A4 inducers (e.g., phenobarbital): may modestly lower exposure.

Frequently Asked Questions

Nintedanib Stada is prescribed for idiopathic pulmonary fibrosis, a progressive lung scarring disease, and for non‑small cell lung cancer, where it is used as part of combination therapy to inhibit tumor growth and angiogenesis.

Nintedanib blocks several receptor tyrosine kinases—VEGFR 1‑3, FGFR 1‑3, and PDGFR α/β—thereby reducing fibroblast activity, new blood‑vessel formation, and tumor cell proliferation, which helps slow fibrosis and tumor progression.

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 exactly.

Safety data for nintedanib in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should be avoided unless the potential benefit justifies the potential risk to the fetus or infant.

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 required import documentation.

Nintedanib is a multi‑kinase inhibitor targeting VEGFR, FGFR, and PDGFR pathways, offering a broader spectrum of activity than agents that inhibit a single receptor. Compared with pirfenidone, another antifibrotic, nintedanib has a distinct side‑effect profile and is often chosen based on patient tolerance and comorbidities.

Nintedanib Stada should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct sunlight. Do not store in a bathroom or near heat sources to maintain product stability.

The medication is taken orally, usually with food to reduce gastrointestinal discomfort. Tablets should be swallowed whole with a full glass of water and not crushed or chewed unless otherwise directed by a healthcare professional.

Serious risks include liver injury, severe bleeding, arterial thromboembolic events, gastrointestinal perforations, and hypertension. Patients should be monitored regularly for signs of these events, and therapy should be discontinued if severe adverse reactions occur.

Nintedanib is contraindicated in patients with severe hepatic impairment, uncontrolled cardiovascular disease, active bleeding disorders, or known hypersensitivity to nintedanib or any of its excipients. It should also be avoided in pregnant women unless the potential benefit outweighs the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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