The pharmaceutical company Boehringer Ingelheim (BI) notified the Therapeutic Goods Administration (TGA) in August 2022 about a shortage of their thrombolytic product tenecteplase. The shortage was due to manufacturing capacity constraints following increases in global demand, and was expected to last until the end of 2023.
BI have informed us that the shortage of tenecteplase will continue until 31 December 2024. The conservation strategies currently employed nationwide will continue to apply.
We thank all clinicians and health services for their support in adopting the conservation strategies which played a key role in minimising the impact of the shortage in Australia.
BI will continue to work closely with states and territories to allocate stock of tenecteplase and facilitate equitable access to all Australians who may need it. BI have advised the TGA that they are confident that the supply of stock throughout 2024 will meet the demand established in 2023.
BI are working to expedite the approval of new manufacturing sites to increase the supply of stock, but there remains a strong global demand for these medicines.
About the shortage
Tenecteplase (Metalyse) injection is used to dissolve blood clots (thrombolysis) in the immediate period following a heart attack. Given the importance of the medicine in critical care settings, we have worked to facilitate ongoing access and equitable supply throughout the shortage, including:
- publishing a joint statement for clinicians, outlining new clinical advice for the use of Metalyse in critical care situations
- extending the shelf life of some batches of tenecteplase to reduce wastage and maximise access
- approving the supply of several overseas-registered equivalent products under section 19A of the Therapeutic Goods Act 1989.
Information for clinicians
Healthcare professionals are asked to continue to implement the conservation methods used throughout the shortage to date. This is to maintain continuity of supply for patients in settings where there are no alternatives.
A printable How to manage Tenecteplase (Metalyse) shortage (pdf,1MB) document is available for clinicians to print and display in relevant health care settings.
Information for clinical trials researchers
The Clinical Trials Project Reference Group has published supplementary advice for researchers about managing trials during the tenecteplase shortage.