Ofev Adverse Reactions

Summary of the safety profile: For the management of selected adverse reactions see Precautions.
Oncology: The safety data provided in the following are based on the global, double-blind randomised pivotal phase III trial 1199.13 (LUME-Lung 1) comparing treatment with Nintedanib esilate (Ofev) plus docetaxel against placebo plus docetaxel in patients with locally advanced, or metastatic, or recurrent NSCLC after first-line chemotherapy and based on data observed during the post-marketing period. The most frequently reported adverse reactions specific for Nintedanib esilate (Ofev) were diarrhoea, increased liver enzyme values (ALT and AST) and vomiting. Table 14 provides a summary of the Adverse Reactions by System Organ Class (SOC).
Clinical trials in adult patients: Idiopathic Pulmonary Fibrosis (IPF), other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD): Nintedanib esilate (Ofev) has been studied in clinical trials including 1529 patients suffering from Idiopathic Pulmonary Fibrosis (IPF), 663 patients with other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype, and 576 patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
The safety data provided in the following are based on: Two phase III, randomised, double-blind, placebo-controlled trials comparing treatment with Nintedanib esilate (Ofev) 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) in 1061 patients with IPF.
One phase III randomised, double-blind, placebo-controlled trial comparing treatment with Nintedanib esilate (Ofev) 150 mg twice daily to placebo for at least 52 weeks in 663 patients with other chronic fibrosing ILDs with a progressive phenotype (INBUILD).
One phase III randomized, double-blind, placebo-controlled trial comparing treatment with Nintedanib esilate (Ofev) 150 mg twice daily to placebo for at least 52 weeks in 576 patients with SSc-ILD (SENSCIS).
Data observed during the post-marketing experience.
In clinical trials, the most frequently reported adverse reactions associated with the use of Nintedanib esilate (Ofev) included diarrhoea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.
The safety profile of Nintedanib esilate (Ofev) in a long term extension trial in patients with IPF, treated from 1 up to more than 5 years, was consistent with that observed in the phase III trials (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Tabulated summary of adverse reactions: See Tables 14 and 15.

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