Abraxane (paclitaxel, formulated as albumin-bound nanoparticles): potential presence of strands in intravenous infusion bag
- Medicines and Healthcare products Regulatory Agency
- 12 February 2014
- Therapeutic area:
If thin, translucent or white-to-yellow proteinaceous strands (1–2 mm in length) are visible, filtration is advised.
Article date: February 2014
Abraxane (paclitaxel, formulated as albumin-bound nanoparticles) is a treatment for metastatic breast cancer in patients who have not responded to first-line treatment, or for whom standard anthracycline-containing therapy is not indicated.
There have been reports from Europe of thin, translucent or white-to-yellow proteinaceous strands (1–2 mm in length) being observed during visual inspection of bags of reconstituted paclitaxel suspension for intravenous infusion. The cause of these strands is thought to be an interaction between albumin and silicone oil lubricant within medical devices such as syringes and locks of intravenous bags. There is no evidence of an increased risk of any adverse effect in patients treated with Abraxane containing strands. However, as a precaution we are advising that Abraxane with visible strands should be filtered as outlined below.
Advice for healthcare professionals:
- As a precaution, Abraxane suspension should be inspected visually using standard procedure for presence of particulate matter or discolouration in the infusion bag before administration. The suspension should appear milky and homogenous without visible precipitates
- If strands are visible in the bag, administer Abraxane through an infusion set incorporating a 15 micrometre filter. This filter removes strands and does not change the physical or chemical properties of the reconstituted product. If strands are present and a filter is not available, discard the product
- Suspected adverse reactions or the presence of visible strands in Abraxane can be reported to us on a Yellow Card (www.mhra.gov.uk/yellowcard)
Seeletter sent to healthcare professionals, January 2014
Article citation: Drug Safety Update volume 7 issue 7, February 2014: S1.
Published: 12 February 2014
Therapeutic area: Cancer