Nintedanib (Ofev) was approved for marketing by the U.S. FDA in 2014. It is a tyrosine kinase inhibitor developed by Boehringer Ingelheim, indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Indications for Nintedanib (Ofev)
Primary Indications
Nintedanib (Ofev) is explicitly indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Idiopathic pulmonary fibrosis is a chronic, progressive, fibrotic interstitial lung disease characterized by fibrosis of the lung parenchyma and abnormal remodeling of alveolar structures, leading to progressive deterioration of lung function.
Dosage Forms, Strengths and Composition of Nintedanib (Ofev)
Strengths and Dosage Forms
Nintedanib is available as soft capsules in two strengths.
150mg capsules: Brown opaque oval soft capsules, imprinted in black with Boehringer Ingelheim's logo and the text "150".
100mg capsules: Peach opaque oval soft capsules, imprinted in black with Boehringer Ingelheim's logo and the text "100".
Composition
Active Ingredient
Each capsule contains 150mg or 100mg of nintedanib (present as the ethanesulfonate salt, corresponding to 180.60mg and 120.40mg of nintedanib ethanesulfonate, respectively).
Excipients
Filling materials: Triglycerides, stearin, lecithin.
Capsule shell: Gelatin, glycerin, titanium dioxide, iron oxide red, iron oxide yellow.
Printing ink: Shellac, iron oxide pigments.
Chemical Properties
Nintedanib ethanesulfonate is a bright yellow powder. Its chemical name is a 1H-indole-6-carboxylic acid derivative, with a molecular formula of C₃₁H₃₃N₅O₄·C₂H₆O₃S and a molecular weight of 649.76 g/mol.
The solubility of this compound increases at pH < 3; however, clinical studies have shown that proton pump inhibitors or H₂ receptor antagonists do not affect its exposure.
Dosage and Administration of Nintedanib (Ofev)
Standard Dosing Regimen
Recommended dose: 150mg twice daily (approximately 12 hours apart), taken with food.
The maximum daily dose should not exceed 300mg.
Administration Requirements
Capsules must be swallowed whole; chewing or crushing is not allowed.
If a dose is missed, do not make up for it; take the next dose at the originally scheduled time.
Liver function tests are required before initiating treatment.
