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

Nintedanib Eg

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Eg (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Eg, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in appropriate patients.

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

Manufacturer / TM Owner

Eurogenerics N.V./S.A.

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Indications & Clinical Uses

Nintedanib is used in fibrotic lung diseases and certain cancers, targeting pathways that drive fibroblast proliferation and tumor growth.

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

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), fibroblast growth factor receptors (FGFR 1‑3) and platelet‑derived growth factor receptors (PDGFR‑α/β). By blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby limiting fibrotic remodeling and tumor vascularization.

Side Effects

Nintedanib may cause a range of adverse reactions, from mild to serious. Patients should be monitored regularly for any new symptoms.

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may affect appetite.
  • Vomiting: occasional episodes, usually self‑limiting.
  • Abdominal pain: discomfort in the stomach area.
  • Decreased appetite: reduced desire to eat, can lead to weight loss.
  • Weight loss: unintended loss of body weight.

Serious or Rare Side Effects

  • Elevated liver enzymes: may indicate hepatic injury.
  • Bleeding events: increased risk of gastrointestinal or other bleeding.
  • Cardiovascular events: such as hypertension or arterial thromboembolism.
  • Severe infections: opportunistic infections in immunocompromised patients.
  • Gastrointestinal perforation: rare but potentially life‑threatening.
  • Allergic reactions: rash, pruritus, or anaphylaxis in extreme cases.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline organ function and consider potential risks.

  • Liver function monitoring: check ALT, AST, and bilirubin before and during treatment.
  • Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use.
  • Cardiovascular evaluation: review history of hypertension, ischemic disease, or thromboembolism.
  • Pregnancy and lactation: avoid use unless benefits outweigh unknown risks.
  • Drug interaction review: assess all concomitant medicines for CYP3A4 or P‑gp relevance.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Nintedanib can interact with several drug classes; some combinations should be avoided while others require close monitoring.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
  • Antiplatelet agents (e.g., aspirin, clopidogrel): additive hemorrhagic potential.
  • P‑glycoprotein inhibitors (e.g., verapamil): may raise plasma levels.
  • High‑dose aspirin (>325 mg): increased gastrointestinal toxicity.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Diuretics: monitor electrolytes and renal function.
  • NSAIDs: watch for additive GI irritation.
  • Statins metabolized by CYP3A4: consider dose adjustment.
  • Herbal supplements (e.g., St John’s wort): potential induction of metabolism.

Frequently Asked Questions

Nintedanib Eg is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination therapy for non‑small cell lung cancer. In each case the drug targets pathways that contribute to fibrosis or tumor angiogenesis, helping to slow disease progression.

Nintedanib blocks several receptor tyrosine kinases, notably VEGFR, FGFR and PDGFR. By inhibiting these receptors it reduces fibroblast activation, new blood‑vessel formation, and the deposition of extracellular matrix, which together limit fibrotic tissue development and tumor vascular support.

The specific dose and dosing schedule of Nintedanib Eg are determined by the prescribing clinician based on the patient’s condition, renal and hepatic function, and concomitant therapies. Healthcare professionals should follow the latest prescribing information and adjust as needed.

Safety data for Nintedanib in pregnancy and lactation are limited. The drug should be used only if the potential benefit justifies any potential risk to the fetus or infant. Women of childbearing potential should use effective contraception during treatment and for a suitable period after discontinuation.

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 the necessary import documentation.

Nintedanib differs from other antifibrotics such as pirfenidone by targeting a broader range of tyrosine kinases, which may provide additional benefit in certain interstitial lung diseases and in combination cancer regimens. Choice of therapy depends on disease severity, patient tolerance, drug‑drug interaction profile, and clinician judgment.

Nintedanib Eg should be stored at room temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight, and excessive heat to maintain stability and potency throughout its shelf life.

Nintedanib Eg is taken orally, usually with food to reduce gastrointestinal discomfort. The tablets or capsules are swallowed whole with a glass of water. Patients should follow the dosing instructions provided by their healthcare professional and not alter the regimen without medical advice.

Serious risks include liver enzyme elevations that may signal hepatic injury, significant bleeding events especially when combined with anticoagulants, cardiovascular complications such as hypertension or arterial thromboembolism, and rare but severe gastrointestinal perforations. Prompt medical evaluation is required if any of these occur.

Nintedanib is contraindicated in patients with known hypersensitivity to the active substance or any excipients, in those with severe hepatic impairment, and in individuals receiving strong CYP3A4 inhibitors where the risk of toxicity outweighs benefit. Clinicians should also exercise caution in patients with active bleeding disorders or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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