Product image of Ofev (Nintedanib) supplied by GNH India

Ofev

Active Ingredient:
Nintedanib
Origin:
EU

Ofev (Nintedanib)

Nintedanib, the active ingredient in Ofev, is a tyrosine kinase inhibitor presented as a 100 mg/150 mg hard gelatin capsule for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used with docetaxel for non‑small cell lung cancer in eligible patients.

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

Manufacturer / TM Owner

Boehringer Ingelheim International Gmbh

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Indications & Clinical Uses

Nintedanib is indicated for fibrotic lung diseases and certain oncologic regimens.

  • Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
  • Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening.
  • Non‑small cell lung cancer (in combination with docetaxel): enhances overall survival and response rates in previously treated patients.

How It Works

  • Nintedanib blocks multiple receptor tyrosine kinases—including VEGFR 1‑3, PDGFR α/β, and FGFR 1‑3—thereby interrupting signaling pathways that drive fibroblast proliferation, migration, and transformation, as well as angiogenesis. This multi‑target inhibition reduces extracellular matrix deposition and tumor vascularization, underpinning its antifibrotic and anti‑cancer actions.

Side Effects

Nintedanib may be associated with a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may occur early in treatment.
  • Decreased appetite: reduced desire to eat.
  • Abdominal pain: mild discomfort in the stomach area.

Serious or Rare Side Effects

  • Liver enzyme elevation: increased ALT/AST indicating hepatic stress.
  • Bleeding events: gastrointestinal or other hemorrhage.
  • Severe infections: opportunistic or serious bacterial infections.

Precautions & Warnings

Before initiating Ofev, several precautions should be considered to ensure safe use.

  • Monitor liver function: perform baseline and periodic ALT/AST tests.
  • Assess bleeding risk: evaluate history of ulcers or anticoagulant use.
  • Observe gastrointestinal symptoms: manage diarrhea and nausea promptly.
  • Evaluate cardiovascular status: monitor blood pressure and signs of thromboembolism.
  • Store at ambient temperature below 25°C: keep capsules in original packaging, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nintedanib levels.
  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): reduce nintedanib exposure.
  • Anticoagulants (e.g., warfarin): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

  • P‑gp inhibitors (e.g., verapamil): may raise drug concentrations.
  • P‑gp inducers (e.g., St. John’s wort): may lower drug concentrations.
  • Other anti‑angiogenic agents (e.g., bevacizumab): potential additive toxicity.

Frequently Asked Questions

Ofev is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for patients with non‑small cell lung cancer when used together with docetaxel after prior therapy. These indications reflect its antifibrotic and anti‑angiogenic properties.

Nintedanib inhibits several receptor tyrosine kinases such as VEGFR, PDGFR and FGFR. By blocking these pathways it reduces fibroblast activity, extracellular matrix formation, and abnormal blood vessel growth, which together help slow fibrosis and limit tumor vascularisation.

The exact dose of Ofev is determined by the prescribing clinician based on the approved indication, patient weight, renal function and tolerability. Available strengths are 100 mg and 150 mg hard gelatin capsules, and the prescriber selects the appropriate regimen for each individual.

Ofev is classified as pregnancy category D, indicating evidence of risk to the fetus. It is not recommended for use during pregnancy unless the potential benefit justifies the risk. Breastfeeding is also discouraged because the drug may pass into milk; patients should discuss alternatives with their healthcare provider.

To order Ofev, 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.

Both Ofev (nintedanib) and pirfenidone are approved for idiopathic pulmonary fibrosis, but they have different mechanisms; Ofev targets multiple tyrosine kinases, while pirfenidone has anti‑inflammatory and antifibrotic actions. Clinical choice often depends on patient tolerance, drug‑drug interaction profile, and physician experience.

Ofev capsules should be stored at ambient temperature below 25 °C, in their original blister pack, protected from moisture and direct sunlight. Do not refrigerate or freeze the product, and keep it out of reach of children.

Ofev is taken orally as a hard gelatin capsule, usually with food to lessen gastrointestinal upset. The capsule should be swallowed whole with water and not crushed, chewed, or opened. Dosing timing and frequency are set by the prescribing clinician.

Serious risks include elevated liver enzymes indicating hepatic injury, bleeding complications such as gastrointestinal hemorrhage, and severe infections. Patients should report any signs of jaundice, unusual bruising, blood in stool or vomit, and persistent fever to their healthcare professional promptly.

Ofev should be avoided in patients with severe hepatic impairment, active bleeding disorders, uncontrolled hypertension, or those receiving strong CYP3A4 inducers that markedly reduce drug exposure. Contra‑indications also include known hypersensitivity to nintedanib or any capsule excipients.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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