Sanofi is facing increasing global demand for Clexane (enoxaparin) solution for injection. In the UK, there has also been an increased use of Clexane due to recent shortages of some of the other low molecular weight heparins in the marketplace. This has put pressure on Sanofi's usual supply of Clexane to the UK.
From early March Sanofi will be introducing new compact packaging for the following Clexane presentations:
The 12,000 IU (120mg) / 0.8ml Clexane Syringe and 15,000 IU (150mg) / 1.0ml Clexane Syringe will continue in the existing packaging.
The new Clexane compact packs are significantly smaller than the current packaging, providing a reduction in occupied space on the shelves (see table in the Q&A below). The transition to the new packaging is in response to feedback from Healthcare professionals and will improve the continuity of supply to the UK.
On the 7th January 2019, Sanofi UK were informed that a batch of Clexane 4,000 IU (40mg)/0.4ml Pre-Filled Syringes planned to be delivered on 8th January 2019 had failed a quality release test. Delivery has now been placed on hold pending further investigation and re-testing. The anticipated delivery date of the failed batch is now early February, and the next scheduled delivery after that is the 18th February 2019.
In order to minimise the impact of the shortage of Clexane 4,000 IU (40mg)/0.4ml syringes Sanofi UK will be introducing, on a temporary basis, the Italian pack with the PREVENTIS (user activation) safety system.
For a short period of time, we will be supplying imported LICENSED Italian Clexane 4,000 IU (40mg)/0.4ml syringes with the PREVENTIS safety system in the UK. It is still the same Clexane from Sanofi but it comes and with a different safety system. Although in the original Italian packaging, the box will contain an English (rather than Italian) patient information leaflet.
In order to help you understand and manage this situation, please find below some useful documentation