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 or 150 mg hard gelatin capsule for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in appropriate patients.

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

Manufacturer / TM Owner

Boehringer Ingelheim International Gmbh

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Indications & Clinical Uses

Ofev (nintedanib) is used in fibrotic lung diseases and certain cancers, targeting pathways that drive fibroblast activity and tumor growth.

  • Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
  • Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and delays worsening of respiratory symptoms.
  • Non‑small cell lung cancer (in combination therapy): contributes to disease control by inhibiting tumor angiogenesis.

How It Works

  • Nintedanib blocks multiple receptor tyrosine kinases, notably VEGFR 1‑3, PDGFR‑α/β and FGFR 1‑3. Inhibition of these receptors reduces fibroblast proliferation, migration and transformation, while also exerting anti‑angiogenic effects that limit tumor vascularisation, thereby curbing fibrotic tissue formation and tumor growth.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may be transient.
  • 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.
  • Severe bleeding: gastrointestinal or other hemorrhage.
  • Cardiovascular events: myocardial infarction or stroke.

Precautions & Warnings

Before initiating therapy, clinicians should assess several safety parameters.

  • Monitor liver function: perform baseline and periodic ALT/AST tests.
  • Assess bleeding risk: avoid in patients with active ulcers or excessive anticoagulant use.
  • Evaluate cardiovascular status: caution in patients with recent myocardial infarction.
  • Pregnancy warning: contraindicated in pregnancy; use effective contraception.
  • Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Nintedanib interacts with several drug classes that may alter its exposure or increase adverse events.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampicin): may reduce efficacy.
  • P‑glycoprotein inhibitors (e.g., verapamil): may modestly increase levels.
  • NSAIDs or antiplatelet agents: additive bleeding potential.

Frequently Asked Questions

Ofev is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination therapy for non‑small cell lung cancer. In each case the drug aims to slow disease progression by targeting pathways that drive fibrosis or tumor angiogenesis.

Nintedanib inhibits several receptor tyrosine kinases, including VEGFR, PDGFR and FGFR. By blocking these signals it reduces fibroblast proliferation, migration and transformation, and also limits new blood‑vessel formation, which together help control fibrotic tissue and tumor growth.

The exact dose of Ofev is set by the prescribing clinician based on the approved indication, patient weight, renal and hepatic function, and any concomitant medications. No fixed regimen is provided here; dosing decisions are individualized by the treating physician.

Nintedanib is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should not be used during pregnancy, and women of child‑bearing potential must use effective contraception. Safety during breastfeeding has not been established, so avoidance is recommended.

To place an order, submit an enquiry on the Ofev 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 required import documentation.

The primary alternative for fibrotic lung disease is pirfenidone, another antifibrotic agent. While both slow disease progression, nintedanib targets multiple tyrosine kinases, offering broader anti‑angiogenic activity, whereas pirfenidone’s mechanism centers on reducing fibroblast activation. Choice depends on patient tolerance, comorbidities and physician judgment.

Ofev capsules should be stored below 25 °C in their original packaging, protected from moisture and direct sunlight. Do not store in a bathroom or other humid environment, and keep the container tightly closed when not in use.

Ofev is taken orally as a hard gelatin capsule. It should be swallowed whole with a glass of water, preferably with food to lessen gastrointestinal discomfort. The capsule should not be opened, chewed, or crushed.

The most serious adverse events include hepatotoxicity (significant liver enzyme elevations or liver injury), severe bleeding (including gastrointestinal hemorrhage), and cardiovascular events such as myocardial infarction or stroke. Patients should be monitored regularly for signs of these conditions.

Ofev is contraindicated in pregnant women, patients with severe hepatic impairment, and those with active, uncontrolled bleeding. Caution is also advised for individuals with recent major cardiovascular events or uncontrolled hypertension. Clinicians must evaluate each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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