Ofev® (nintedanib) - Risk of severe liver injury in patients with idiopathic pulmonary fibrosis

Boehringer Ingelheim would like to inform healthcare professionals that post-marketing cases of drug-induced liver injury (DILI) have been reported in patients with idiopathic pulmonary fibrosis (IPF) treated with Ofev®. Majority of the hepatic events occurred within the first three months of Ofev® initiation. Therefore, transaminases and bilirubin levels should be investigated upon initiation of treatment, at regular intervals during the first three months of treatment and periodically thereafter (e.g. at each patient visit) or as clinically indicated. Boehringer Ingelheim is working with HSA to update the package insert for Ofev® to reflect the new information on the cases of DILI and to provide further guidance on the monitoring schedule of the liver function. Please refer to the letter for details. 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.