Joint statement: Shortage of tenecteplase (Metalyse)

Boehringer Ingelheim has advised the Therapeutic Goods Administration (TGA) of shortages of both strengths of their thrombolytic product tenecteplase (Metalyse) until the end of 2023. The shortage is due to manufacturing capacity constraints following increases in global demand.

Tenecteplase (Metalyse) is indicated for the thrombolytic treatment of the acute phase of myocardial infarction. The TGA is aware of off-label use, particularly in areas/settings where access or ability to use alternative treatments is limited.

To ensure supply does not run out, the TGA has worked with stakeholders to develop recommendations advising clinicians and health service staff on how they can conserve supply.

Healthcare professionals must implement conservation methods to maintain continuity of supply for patients in settings where there are no alternatives.

The TGA has modelled supply of tenecteplase and alteplase with Boehringer Ingelheim and the state and territory health department representatives in the Medicine Availability Working Group. The Working Group has agreed that usage of tenecteplase must be reduced by at least 35% nationally or tenecteplase stock will be exhausted in Australia by the end of 2022.

The TGA has worked with stakeholders to develop recommendations to achieve this level of conservation.

This statement has been co-developed by the TGA and:

• Aboriginal Community Controlled Health Services
• Aboriginal Health Council of Western Australia
• Cardiac Society of Australia and New Zealand
• Council of Ambulance Authorities
• Royal Flying Doctors Service, Western Operations
• Society of Hospital Pharmacists of Australia
• Stroke Foundation
• Stroke Society
• The Australian College of Rural and Remote Medicine
• The National Aboriginal Community Controlled Health Organisation.

The TGA is monitoring the supply situation and will work with stakeholders to update this advice if required.

Prioritisation and conservation

Tenecteplase (Metalyse) supply must be prioritised for settings where there are no alternatives.

Clinicians are asked to adopt the following recommendations from the beginning of October 2022. Prior to this, Boehringer Ingelheim will increase stock of alteplase (Actilyse) to allow for the increased use of alteplase in place of tenecteplase for some indications.

Healthcare professionals are urged to avoid stockpiling.

These recommendations will be reviewed as supply improves.

Clinical recommendations

• Tenecteplase should be prioritised for:
  • pre-hospital thrombolysis (e.g. ambulance services)
  • small rural and remote facilities/hospitals, including Aboriginal health services.
• Alteplase should be used in metropolitan and larger regional hospitals to conserve tenecteplase for the above settings
• Any out-of-date tenecteplase products should be set aside and not disposed of pending further decisions on potential expiry date extensions.

Additional information

Shelf-life extension

• The TGA has approved a submission from Boehringer Ingelheim to extend the shelf-life of certain batches of Metalyse by 12 months to maximise access to tenecteplase. Information on batch numbers with an extended shelf-life is available on the Shortage of tenecteplase (Metalyse) web statement .
• Hospital pharmacists and ambulance services are encouraged to make appropriate changes to Metalyse packaging to reflect the extended shelf-life to ensure stock is not accidently disposed of.

Additional supply

• The TGA has approved the temporary supply of overseas-registered equivalent products under section 19A of the Therapeutic Goods Act 1989, however supply during a global shortage is likely to be unstable. Contact numbers for suppliers of these products can be found on the TGA's section 19A database.

Contact details for further information

• For further information on supply and availability of Australian Metalyse and Actilyse products please call Boehringer Ingelheim on 02 8875 8800.
• If you have any questions about this statement, please call the TGA’s Medicine Shortage Section on 02 6289 4646.

Clinicians and health professionals are encouraged to print the following simplified statement to display in relevant health settings:

• How to manage Tenecteplase (Metalyse) shortage (pdf,1MB)