Metalyse (tenecteplase) shortage shelf-life extension expanded

We have approved a 12-month shelf-life extension of all Metalyse batches that have an original expiry date from January 2022 to March 2025. The extension does not apply to batches of Metalyse with an original expiry date before January 2022 or after March 2025.

This is in response to the shortage of Metalyse injection that is predicted to extend to the end of 2023. Boehringer Ingelheim (BI) have advised that the shortage is due to manufacturing capacity constraints following increases in global demand.

Metalyse injection is used to dissolve blood clots (thrombolysis) in the immediate period following a heart attack.

Hospital pharmacists and ambulance services are encouraged to make appropriate changes to Metalyse packaging to reflect the extended shelf-life of additional batches.

In collaboration with expert groups, clinical recommendations have been developed to assist healthcare professionals during this shortage. The full statement outlining the recommendations is available at Joint statement: Shortage of Metalyse.

A printable page is also available for clinicians to display in relevant health settings How to manage Metalyse shortage (pdf,1MB).

In addition, we have approved the supply of several overseas-registered equivalent products under section 19A of the Therapeutic Goods Act 1989, to minimise the public health impact of this shortage. For information on supply, contact the approval holders:

• Pro Pharmaceuticals Group Pty Ltd on 1300 077 674
• Medsurge Healthcare Pty Ltd on 1300 788 261

Information for clinical trials researchers

The Clinical Trials Project Reference Group has published supplementary advice for researchers about managing trials during the Metalyse shortage.