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

Nintedanib Adalvo

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Adalvo (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Adalvo, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis in adult patients, helping to slow disease progression.

GNH India supplies Nintedanib Adalvo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company follows strict quality standards and provides regulatory support for global distribution.

Manufacturer / TM Owner

Adalvo Limited

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Indications & Clinical Uses

Nintedanib is used in the management of fibrotic lung diseases, primarily targeting progressive interstitial lung conditions.

  • Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
  • Systemic sclerosis‑associated interstitial lung disease: decreases rate of forced vital capacity loss.

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 attenuating the fibrotic remodeling process in the lung.

Side Effects

Nintedanib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: frequent loose stools, often manageable with diet.
  • Vomiting: occasional episodes, usually early in therapy.
  • Abdominal pain: cramping or discomfort in the stomach area.
  • Decreased appetite: reduced desire to eat, may affect weight.
  • Weight loss: modest loss observed in some patients.

Serious or Rare Side Effects

  • Liver enzyme elevation: significant increase in ALT/AST requiring monitoring.
  • Bleeding events: heightened risk of gastrointestinal or other bleeding.
  • Cardiovascular complications: including myocardial infarction or stroke.
  • Severe infections: opportunistic infections in immunocompromised individuals.
  • Gastrointestinal perforation: rare but potentially life‑threatening.

Precautions & Warnings

When prescribing Nintedanib, clinicians should observe several precautionary measures to ensure patient safety.

  • Liver function monitoring: assess ALT/AST before and during treatment.
  • Bleeding risk assessment: evaluate concomitant anticoagulant use and history of ulcers.
  • Cardiovascular evaluation: review history of ischemic heart disease or stroke.
  • Pregnancy avoidance: drug is not recommended for pregnant or nursing women.
  • Hepatic impairment dose adjustment: consider reduced exposure in moderate liver dysfunction.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Nintedanib can interact with other medicines, influencing its plasma levels or increasing the risk of adverse events.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure.
  • Potent P‑gp inhibitors (e.g., verapamil): can raise systemic concentrations.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise levels.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Antacids or proton‑pump inhibitors: may affect absorption if taken simultaneously.

Frequently Asked Questions

Nintedanib Adalvo is prescribed to treat idiopathic pulmonary fibrosis, a chronic, progressive lung disease. It helps slow the decline in lung function and may also be used for systemic sclerosis‑associated interstitial lung disease, reducing fibrosis progression in adult patients.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—thereby inhibiting fibroblast activation, angiogenesis and extracellular matrix formation. This multi‑target inhibition curtails the pathological scarring process that characterises fibrotic lung disorders.

The dosing regimen for Nintedanib Adalvo is determined by the prescribing physician based on the patient’s clinical condition, renal and hepatic function, and concomitant therapies. Patients should follow the exact instructions provided by their healthcare professional.

Safety data for Nintedanib in pregnancy and lactation are limited. The drug is classified as contraindicated or not recommended for use in pregnant or nursing women because potential risks to the fetus or infant cannot be excluded. Effective contraception is advised during treatment.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

The primary alternative for idiopathic pulmonary fibrosis is pirfenidone, an oral antifibrotic with a different safety profile. Nintedanib targets multiple tyrosine kinases, while pirfenidone’s mechanism involves inhibition of TGF‑β signaling. Both slow disease progression, but Nintedanib is associated with higher rates of gastrointestinal side effects, whereas pirfenidone may cause photosensitivity and rash.

Store Nintedanib Adalvo at room temperature, below 25 °C, in the original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing it in humid environments such as bathrooms.

Nintedanib Adalvo is taken orally, usually with food to lessen gastrointestinal discomfort. The tablets should be swallowed whole with a full glass of water and not crushed, chewed, or split unless specifically instructed by a healthcare professional.

The most serious adverse events include significant liver enzyme elevations, which may indicate hepatic injury, and bleeding complications, especially in patients on anticoagulants. Cardiovascular events such as myocardial infarction or stroke have also been reported, requiring prompt medical evaluation if symptoms arise.

Patients with severe hepatic impairment, active bleeding disorders, uncontrolled cardiovascular disease, or who are pregnant or breastfeeding should avoid Nintedanib. Additionally, individuals taking strong CYP3A4 or P‑gp inhibitors should not use the drug without medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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