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.

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

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.