Prolia® (denosumab 60 mg) – Risk of anaphylactic reaction and new contraindication in patients with clinically significant hypersensitivity to Prolia®

GlaxoSmithKline (GSK) would like to notify healthcare professionals that anaphylactic reaction is now identified as an adverse drug reaction associated with Prolia®. In addition, clinically significant hypersensitivity to Prolia® is now identified as a contraindication for use. In the postmarket setting, five spontaneously reported cases of anaphylactic reactions were identified and were considered causally related to Prolia®. No fatal outcomes were observed. To communicate this important information, the Prolia® package insert has been updated with a new contraindication in patients with clinically significant hypersensitivity to denosumab (or any components of the product) and inclusion of anaphylactic reactions as an adverse drug reaction. Please refer to the letter for more information.
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.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

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

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