Product image of Nintedanib supplied by GNH India

Nintedanib

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib

Nintedanib, the active ingredient in Nintedanib, is a tyrosine kinase inhibitor presented as a unknown/oral tablet for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer when used with docetaxel.
GNH India supplies Nintedanib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Sandoz Polska Sp. Z O.O.

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Indications & Clinical Uses

Nintedanib is indicated for several fibrotic and oncologic conditions where inhibition of multiple growth factor receptors is therapeutic.

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening.
  • Non‑small cell lung cancer (in combination with docetaxel): enhances overall response rate and survival in previously treated patients.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases—including 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 also exerts anti‑angiogenic effects that limit tumor vascularisation and growth.

Side Effects

Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhea: frequent, watery stools that may require supportive care.
  • Nausea and vomiting: mild to moderate gastrointestinal upset.
  • Decreased appetite: reduced food intake leading to weight loss.
  • Elevated liver enzymes: transient increases in ALT/AST.
  • Abdominal pain: discomfort in the upper abdomen.

Serious or Rare Side Effects

  • Severe liver injury: jaundice, hepatic failure requiring monitoring.
  • Bleeding events: gastrointestinal or pulmonary hemorrhage, especially with anticoagulants.
  • Arterial thromboembolism: risk of heart attack or stroke.
  • Gastrointestinal perforation: rare but potentially life‑threatening.
  • Severe infections: opportunistic infections in immunocompromised patients.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline organ function and potential risk factors.

  • Liver function monitoring: check ALT/AST before and during treatment.
  • Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use.
  • Cardiovascular evaluation: consider history of arterial thromboembolism.
  • Gastrointestinal caution: avoid in patients with active ulcers or recent perforation.
  • Pregnancy and lactation: avoid use due to unknown safety profile.
  • Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Nintedanib may 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.
  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Anticoagulants (e.g., warfarin) and antiplatelet agents: increase risk of serious bleeding.

Moderate Interactions (Monitor Closely)

  • P‑glycoprotein inhibitors (e.g., verapamil): may modestly increase plasma levels.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): add to gastrointestinal bleeding risk.
  • Other anti‑angiogenic agents: potential additive toxicity on vascular endothelium.

Frequently Asked Questions

Nintedanib is approved for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination with docetaxel in patients with non‑small cell lung cancer who have received prior chemotherapy.

The drug blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby reducing fibroblast activity, limiting scar tissue formation, and inhibiting new blood‑vessel growth that supports tumor progression.

The prescribed dose of Nintedanib is determined by the treating physician based on the specific indication, patient characteristics and any concomitant therapies. Patients should follow the exact regimen provided by their healthcare professional.

The safety of Nintedanib in pregnancy and lactation has not been established. It should be avoided in pregnant or nursing women unless the potential benefit justifies the potential risk, and a prescriber’s guidance is essential.

To request Nintedanib, 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.

Compared with alternatives such as pirfenidone, Nintedanib targets a broader range of growth‑factor receptors, offering a distinct mechanism that may be advantageous in certain patients. Choice of therapy depends on disease severity, tolerability, drug‑interaction profile and clinician judgment.

Nintedanib should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and light. Do not store in a bathroom or near heat sources.

Nintedanib is taken orally, usually as whole tablets swallowed with water. It is generally taken with food to reduce gastrointestinal upset, but patients should follow the specific instructions given by their prescriber.

Serious risks include severe liver injury, significant bleeding events, arterial thromboembolism, gastrointestinal perforation, and opportunistic infections. Patients should be monitored regularly for signs of these complications and report any concerning symptoms promptly.

Nintedanib is contraindicated in patients with severe hepatic impairment, active gastrointestinal bleeding, recent gastrointestinal perforation, or known hypersensitivity to the drug. Caution is also advised for individuals on strong CYP3A4 modulators or anticoagulant therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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