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Nintedanib

Generic Name
Nintedanib
Brand Names
Ofev, Vargatef, Nintedanib Accord
Drug Type
Small Molecule
Chemical Formula
C31H33N5O4
CAS Number
656247-17-5
Unique Ingredient Identifier
G6HRD2P839

Overview

Nintedanib is a small molecule kinase inhibitor used in the treatment of pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and non-small cell lung cancer (NSCLC). It was first approved for use in the United States in 2014. Within the spectrum of idiopathic pulmonary fibrosis treatment options, nintedanib is currently one of only two disease-modifying therapies available and indicated for the condition (the other being Pirfenidone) and as such is used as a first-line treatment following diagnosis to slow down the progressive loss of lung function. As a chemotherapeutic agent for NSCLC, nintedanib, in combination with Docetaxel, is reserved for patients who have tried and failed first-line chemotherapeutic options.

Background

Nintedanib is a small molecule kinase inhibitor used in the treatment of pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and non-small cell lung cancer (NSCLC). It was first approved for use in the United States in 2014. Within the spectrum of idiopathic pulmonary fibrosis treatment options, nintedanib is currently one of only two disease-modifying therapies available and indicated for the condition (the other being Pirfenidone) and as such is used as a first-line treatment following diagnosis to slow down the progressive loss of lung function. As a chemotherapeutic agent for NSCLC, nintedanib, in combination with Docetaxel, is reserved for patients who have tried and failed first-line chemotherapeutic options.

Indication

Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease. It is also indicated for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype. In the EU, under the brand name Vargatef, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy.

Associated Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)
  • Respiratory Function Impaired
  • Chronic Progressive Fibrosing Interstitial Lung Disease
  • Locally advanced Non-Small Cell Lung Carcinoma (NSCLC)
  • Locally recurrent Non-Small Cell Lung Carcinoma (NSCLC)
  • Metastatic Non-Small Cell Lung Carcinoma (NSCLC)

FDA Approved Products

Ofev
Manufacturer:Boehringer Ingelheim Pharmaceuticals, Inc.
Route:ORAL
Strength:100 mg in 1 1
Approved: 2022/10/31
NDC:0597-0143
Ofev
Manufacturer:Boehringer Ingelheim Pharmaceuticals, Inc.
Route:ORAL
Strength:150 mg in 1 1
Approved: 2022/10/31
NDC:0597-0145

Singapore Approved Products

OFEV SOFT CAPSULES 100MG
Manufacturer:Catalent Germany Eberbach GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG (Primary and Secondary Packager)
Form:CAPSULE, LIQUID FILLED
Strength:100mg
Online:Yes
Approved: 2016/01/14
Approval:SIN14921P
OFEV SOFT CAPSULES 150MG
Manufacturer:Catalent Germany Eberbach GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG (Primary and Secondary Packager)
Form:CAPSULE, LIQUID FILLED
Strength:150mg
Online:Yes
Approved: 2016/01/14
Approval:SIN14922P

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