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

Nintedanib Ratiopharm

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Ratiopharm (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Ratiopharm, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease in adult patients.

GNH India supplies Nintedanib Ratiopharm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product meets EU quality standards and is manufactured under GMP conditions.

Manufacturer / TM Owner

Ratiopharm Gmbh

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Indications & Clinical Uses

  • Nintedanib is used to treat fibrotic lung disorders by targeting pathways that drive fibroblast activity.
  • Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function.
  • Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity.
  • Progressive fibrosing interstitial lung disease: decreases rate of lung function loss in eligible patients.

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 generally classified by frequency and severity.

Common Side Effects

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

Serious or Rare Side Effects

  • Severe liver injury (hepatotoxicity)
  • Major bleeding events
  • Arterial thromboembolic events
  • Hypertension
  • Gastrointestinal perforations
  • Severe skin reactions (e.g., Stevens‑Johnson syndrome)

Precautions & Warnings

  • Before initiating therapy, clinicians should assess baseline health status and monitor for specific risks.
  • Liver function monitoring: assess baseline and periodic liver enzymes.
  • Bleeding risk: avoid concomitant anticoagulants unless necessary.
  • Cardiovascular assessment: monitor blood pressure and signs of arterial thrombosis.
  • Gastrointestinal health: watch for signs of perforation, especially in patients with diverticulitis.
  • Pregnancy and lactation: use only if potential benefit justifies risk; data are limited.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light in original container.

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, itraconazole): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
  • P‑glycoprotein inhibitors (e.g., verapamil): may raise plasma levels.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for bleeding.
  • Diuretics: may exacerbate dehydration and renal effects.

Frequently Asked Questions

Nintedanib Ratiopharm is prescribed for adult patients with idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease. It may also be used in certain cases of progressive fibrosing interstitial lung disease to slow the decline in lung function.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—thereby inhibiting fibroblast activation, angiogenesis and extracellular matrix production. This multi‑targeted inhibition reduces the fibrotic remodeling that characterises the lung diseases it treats.

The dosing regimen for Nintedanib Ratiopharm is determined by the prescribing physician based on the patient’s condition, renal and hepatic function, and tolerability. Patients should follow the specific instructions provided by their healthcare professional.

Safety data for Nintedanib in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare provider.

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.

The primary alternative for idiopathic pulmonary fibrosis is pirfenidone, another antifibrotic agent. While both aim to slow disease progression, Nintedanib targets a broader range of tyrosine kinases, whereas pirfenidone’s mechanism involves modulation of cytokine production and oxidative stress. Choice of therapy depends on individual patient factors, tolerability and physician judgment.

Nintedanib tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack to protect them from moisture and light. Keep the medication out of reach of children and do not use after the expiry date printed on the packaging.

Nintedanib is taken orally, usually with food to minimise gastrointestinal discomfort. The tablets are swallowed whole with a glass of water and should be taken at the same times each day as directed by the prescriber.

Serious risks include liver injury, severe bleeding, arterial thromboembolic events, hypertension, and gastrointestinal perforations. Patients should report any signs of jaundice, unusual bruising, severe abdominal pain, or sudden weakness to their healthcare provider promptly.

Nintedanib is contraindicated in patients with known hypersensitivity to the drug or any of its excipients, in those with active severe liver disease, and in individuals who are currently experiencing significant bleeding or have uncontrolled hypertension. Pregnant or breastfeeding women should use it only if clearly indicated by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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