Product image of Nintedanib Zidrium Teva (Nintedanib) supplied by GNH India

Nintedanib Zidrium Teva

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Zidrium Teva (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Zidrium Teva, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and in combination therapy for non‑small cell lung cancer.
GNH India supplies Nintedanib Zidrium Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide, ensuring consistent quality, regulatory compliance, and robust supply chain management.

Manufacturer / TM Owner

Teva Pharma – Produtos Farmacêuticos Lda

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Indications & Clinical Uses

Nintedanib targets fibrotic lung diseases and certain cancers by inhibiting key growth factor receptors.

  • 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 therapy): enhances treatment efficacy when combined with chemotherapy.

How It Works

  • Nintedanib blocks the intracellular kinase activity of multiple receptor tyrosine kinases, including VEGFR 1‑3, PDGFR‑α/β, and FGFR 1‑3. Inhibition of these pathways reduces fibroblast proliferation, migration, and angiogenesis, thereby limiting extracellular matrix deposition and tumor angiogenesis.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may be transient.
  • Vomiting: occasional episodes.
  • Abdominal pain: discomfort in the stomach area.
  • Decreased appetite: reduced desire to eat.
  • Liver enzyme elevation: mild increase in ALT/AST.

Serious or Rare Side Effects

  • Hepatotoxicity: significant liver injury requiring monitoring.
  • Bleeding events: increased risk of gastrointestinal or other bleeding.
  • Cardiovascular events: such as myocardial infarction or stroke.
  • Severe infections: opportunistic infections in immunocompromised patients.

Precautions & Warnings

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

  • Liver function monitoring: assess ALT, AST, bilirubin before and during therapy.
  • Gastrointestinal management: advise patients on hydration and antidiarrheal measures.
  • Cardiovascular assessment: evaluate history of ischemic heart disease before initiation.
  • Bleeding risk evaluation: avoid in patients with active ulcers or on anticoagulants without supervision.
  • Pregnancy and lactation: contraindicated or used only if benefits outweigh risks; discuss with obstetrician.
  • Store at ambient temperature: keep below 25°C in original packaging, protect from moisture and light.

Avoid Interactions

Nintedanib can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
  • High‑dose aspirin or NSAIDs: additive bleeding potential.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise plasma levels.
  • P-glycoprotein inhibitors (e.g., verapamil): could affect drug transport.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce effectiveness.
  • Antacids containing aluminum or magnesium: may decrease absorption if taken simultaneously.

Frequently Asked Questions

Nintedanib Zidrium Teva is an oral tyrosine kinase inhibitor approved for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer. It works by targeting pathways that drive fibrosis and abnormal cell growth.

Nintedanib inhibits multiple receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby reducing fibroblast proliferation, migration and angiogenesis. This blockade limits extracellular matrix deposition in fibrotic lung disease and can also impair tumor blood‑vessel formation in cancer therapy.

The prescribed dose of Nintedanib Zidrium Teva is determined by the treating physician based on the specific indication, patient characteristics and clinical guidelines. Patients should follow the dosing instructions provided by their healthcare professional.

The safety of Nintedanib in pregnancy and lactation has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus, and breastfeeding mothers should discuss alternatives with their obstetrician or pediatrician.

To request Nintedanib Zidrium Teva, 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.

The primary alternative antifibrotic agent is pirfenidone. Both drugs slow disease progression in idiopathic pulmonary fibrosis, but they differ in mechanisms—pirfenidone has anti‑inflammatory and antifibrotic effects, while Nintedanib targets multiple tyrosine kinases. Choice depends on patient tolerance, comorbidities and physician judgment.

Nintedanib should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original container, protect it from moisture and direct light, and ensure the packaging remains sealed until use.

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

Serious risks include liver injury (hepatotoxicity), significant bleeding events, and cardiovascular complications such as myocardial infarction or stroke. Patients should be monitored regularly for liver function abnormalities and signs of bleeding or cardiac issues.

Nintedanib is contraindicated in patients with severe hepatic impairment, active bleeding disorders, or uncontrolled cardiovascular disease. It should also be avoided in individuals who are pregnant or breastfeeding unless the benefits outweigh the risks, and in patients taking strong CYP3A4 inhibitors without medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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