Interruption to supply of Clexane 40mg/0.4ml solution for injection pre-filled syringes

Interruption to supply of Clexane 40mg/0.4ml solution for injection pre-filled syringes

January 23, 2019

Sanofi have advised NHS England and Department of Health and Social Care (DHSC) that there has been a quality issue with a batch of Clexane 40mg that was due to arrive in January 2019.

It is expected that all wholesalers will currently be out of stock.

Further stocks are anticipated mid-February 2019.

To cover the anticipated shortfall in stock available, Sanofi have imported Clexane 40mg from Italy, this will be classed as licensed in the UK. Sanofi are working with Medicines and Healthcare products Regulatory Agency (MHRA) to make this available from 23rd January 2019, via usual ordering methods.

Key differences that community pharmacy teams need to be aware of are indicated in the table below:

The most important difference between the Italian and UK preparations is the difference in the needle guard device. To deploy the Preventis needle shield on the Italian syringes, users will need to firmly push the plunger after completing the injection. The user will hear an audible “click” to confirm the activation of the protective sleeve and the protective sleeve will automatically cover the needle. Patients and HCPs will need to be trained on this new device; instructions for use can also be found within the PIL. This product will NOT be over-labelled in English but an English PIL will be included in the pack.

If stock is required prior to the 23rd January, alternative Enoxaparin biosimilar agents include Inhixa (Techdow) and Arovi (Rovi Biotech)

Action for community pharmacy teams

DHSC advises community pharmacy teams to review their current Clexane 40mg injection patients and determine if they have sufficient supplies until the next Clexane 40mg stock becomes available – 23rd January for the Italian imported (UK licensed) stock and currently 18th February for further UK Clexane 40mg stock.

DHSC has also suggested GPs and pharmacies work closely to discuss local management options.

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