Update
- Read the latest Tenecteplase (Metalyse) shortage update (17 August 2023).
- There is a 3 April 2023 update to this alert related to shelf-life: Tenecteplase (Metalyse) shortage shelf-life extension expanded. 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 published a statement with clinical recommendations to assist healthcare professionals during this shortage
- The Clinical Trials Project Reference Group has published supplementary advice to provide guidance for researchers
Boehringer Ingelheim (BI) has advised the Therapeutic Goods Administration (TGA) of a shortage of tenecteplase (Metalyse) injection that is predicted to extend over the next 18 months. 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.
To reduce wastage and maximise access to this essential medicine, the TGA has approved a submission from BI to extend the shelf-life of certain batches of Metalyse by 12 months, noting no change to the efficacy or safety of the therapy. These include:
| Medicine name | Batch number | Original (Printed) expiry date | Extended expiry date |
|---|---|---|---|
|
METALYSE tenecteplase (rch) 40mg powder for injection vial plus prefilled syringe (ARTG 75012) |
007057 |
31/07/2022 |
31/07/2023 |
|
101396 |
30/11/2022 |
30/11/2023 |
|
|
METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe (ARTG 75013) |
006382 |
31/07/2022 |
31/07/2023 |
|
101397 |
30/11/2022 |
30/11/2023 |
Hospital pharmacists and ambulance services are encouraged to make appropriate changes to Metalyse packaging to reflect the extended shelf-life.
The TGA continues to work closely with Boehringer Ingelheim and clinical experts to evaluate the likely impact of interruptions to Metalyse supply. 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 here.
A printable How to manage Tenecteplase (Metalyse) shortage (pdf,1MB) is also available for clinicians to print and display in relevant health settings.
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.