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

Nintedanib Pliva

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Pliva (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Pliva, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and for use in combination therapy for non‑small cell lung cancer in adult patients.

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

Manufacturer / TM Owner

Pliva Hrvatska D.O.O.

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Indications & Clinical Uses

Nintedanib targets fibrotic and oncologic pathways in specific respiratory and cancer conditions.

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition when combined with standard chemotherapy.
  • Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity in adult patients.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR) and platelet‑derived growth factor receptors (PDGFR). By blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and the fibrotic remodeling that underlies progressive lung disease and tumor growth.

Side Effects

Nintedanib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

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

Serious or Rare Side Effects

  • Hepatic failure or severe liver injury
  • Arterial thromboembolic events (e.g., myocardial infarction, stroke)
  • Major bleeding episodes
  • Gastrointestinal perforation
  • Severe hypertension

Precautions & Warnings

Before initiating therapy, clinicians should evaluate several safety considerations.

  • Liver function monitoring: assess baseline enzymes and repeat regularly.
  • Cardiovascular assessment: screen for history of arterial thromboembolism.
  • Bleeding risk: avoid in patients with active bleeding or uncontrolled anticoagulation.
  • Gastrointestinal health: use caution in patients with ulcer disease or recent surgery.
  • Severe hepatic impairment: contraindicated.
  • Store at ambient temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Nintedanib can interact with other medicines through metabolic pathways and additive pharmacodynamic effects.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole).
  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine).
  • Anticoagulants (e.g., warfarin) that may increase bleeding risk.
  • Antiplatelet agents (e.g., aspirin, clopidogrel) that may exacerbate hemorrhage.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin).
  • Moderate CYP3A4 inducers (e.g., phenytoin, phenobarbital).
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) that add gastrointestinal bleeding risk.
  • Diuretics that may affect blood pressure control.

Frequently Asked Questions

Nintedanib Pliva is prescribed for adult patients with idiopathic pulmonary fibrosis to slow disease progression, and as part of combination chemotherapy regimens for non‑small cell lung cancer. It may also be used in systemic sclerosis‑associated interstitial lung disease where approved.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—thereby inhibiting pathways that drive fibroblast proliferation, new blood‑vessel formation and fibrotic tissue remodeling. This dual antifibrotic and anti‑angiogenic activity underlies its therapeutic effect in lung fibrosis and certain cancers.

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

Safety data for Nintedanib in pregnancy and lactation are limited. It is generally advised to avoid use during pregnancy unless the potential benefit justifies the risk, and breastfeeding should be discontinued while on therapy because drug excretion in milk cannot be excluded.

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 necessary import documentation.

For idiopathic pulmonary fibrosis, the primary alternative is pirfenidone, another antifibrotic agent with a different safety profile. Nintedanib’s multitarget kinase inhibition offers broader anti‑angiogenic activity, which can be advantageous in certain cancer regimens, whereas pirfenidone works mainly through anti‑inflammatory mechanisms.

Store Nintedanib Pliva at ambient temperature, preferably below 25 °C. Keep the product in its original packaging to protect it from moisture and light. Do not refrigerate or freeze the tablets, and retain them out of reach of children.

Nintedanib Pliva 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.

Clinicians and patients should be vigilant for signs of severe liver injury (jaundice, dark urine), major bleeding events (hematuria, gastrointestinal hemorrhage), arterial thromboembolic episodes (chest pain, sudden weakness), and gastrointestinal perforation. Prompt medical evaluation is required if any of these occur.

Nintedanib is contraindicated in patients with severe hepatic impairment, active uncontrolled bleeding, recent major cardiovascular events, or known hypersensitivity to the drug. Caution is also advised for individuals with moderate liver disease, uncontrolled hypertension, or a history of gastrointestinal ulcers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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