ABRAXANE® Injection 100mg/vial: Visible strands in the intravenous infusion bag

Celgene Pte Ltd would like to inform healthcare professionals that cases of of thin, translucent or white to yellow proteinaceous strands observed during visual inspection of reconstituted ABRAXANE® (paclitaxel formulated as albumin bound nanoparticles) suspension in an intravenous infusion bag were reported. The root cause for formation of these strands has been determined to be an interaction of albumin, a major component of ABRAXANE® suspension, with silicone oil lubricant within a medical device. There is no indication of an increased risk of embolic events should these strands inadvertently be administered to patients. However, as a precautionary measure, ABRAXANE® suspension should be inspected visually using standard procedure for particulate matter or discoloration in the infusion bag prior to administration and a 15 μm filter should be used if strands are present. 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.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.