Gavreto® (pralsetinib) - new warning and precaution of severe and fatal infections

A Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals that severe and fatal infections, including opportunistic infections, have been reported in patients treated with Gavreto®. An ad hoc analysis of results from the ongoing phase III trial AcceleRET-Lung demonstrated an imbalance regarding the risk of severe and fatal infection, including severe opportunistic infections, between the pralsetinib and standard of care arms. Healthcare professionals are advised to monitor patients closely for signs and symptoms of infection and treat appropriately. They are also advised to withhold Gavreto® in the presence of active infection and discontinue Gavreto® permanently if infections are life-threatening. Please refer to the letter for details.

Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

29 Oct 2024

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.