This alert is an update to Shortage of tenecteplase (Metalyse). The 12-month shelf-life extension now applies to all Metalyse batches with an original expiry date between January 2022 to March 2025.
We have approved a 12-month shelf-life extension of all Metalyse tenecteplase 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 tenecteplase (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.
Tenecteplase (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 tenecteplase (Metalyse).
A printable page is also available for clinicians to display in relevant health settings How to manage Tenecteplase (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 tenecteplase shortage.