Veletri (epoprostenol) powder for solution for infusion: incompatibilities with some models of administration devices

Reports of reconstituted solution leaking from some models of extension sets and pumps.

Veletri is a high-pH form of epoprostenol. Epoprostenol is indicated for the treatment of pulmonary arterial hypertension. Epoprostenol is also indicated for haemodialysis in emergency situations when the use of heparin carries a high risk of causing or worsening bleeding or when heparin is otherwise contraindicated.

There have been five reports of the reconstituted solution leaking from some models of extension sets and pumps in the UK and one report from the Netherlands. All but one case concerned patients treated for pulmonary arterial hypertension. No adverse events were reported. However, leaking may increase the following risks:

  • the solution has a pH at the time of administration ranging from 11.0 to 12.0 - leaking of the solution for infusion could cause local skin irritation
  • changes to the physical integrity of the administration components could create a risk for microbial contamination
  • leaking might reduce patient compliance

Advice for healthcare professionals

The following administration accessories are known to be suitable for use with Veletri:

  • pumps (manufactured by Smiths Medical group)
    • CADD-Legacy 1
    • CADD-Legacy PLUS
  • Pump accessories (from Smiths Medical International Ltd.)
    • CADD disposable cassettes (Medication Cassette Reservoir with clamp, female luer and non-vented stopper – reference 21-7001-24 for the 50 ml; 21-7002-24 for the 100 ml)
    • CADD extension set with in-line 0.2 micron filter (CADD extension set with male luer, 0.2-micron air-eliminating filter, clamp, and integral anti-siphon valve with male luer – reference 21-7106)
  • only use extension sets with an in-line 0.22 micron filter placed between the infusion pump and the central venous catheter

  • change the extension set and the in-line filter at least every 48 hours

Further information

Summary of product characteristics and patient information leaflet

Article citation: Drug Safety Update volume 8 issue 5, December 2014: A5

Published 19 December 2014