Availability of Metalyse®

HPS Pharmacies wish to advise that Boehringer Ingelheim is experiencing a long-term supply interruption for Metalyse^® as follows:

Metalyse^® Injection
Tenecteplase (rch) 40mg
ARTG 75012 

Metalyse^® Injection
Tenecteplase (rch) 50mg
ARTG 75013

This supply interruption is predicted to extend over the next 18 months, until the end of 2023. The shortage is due to increased global demand and limited production capacity.

To maximise access to this essential medicine, the Therapeutic Goods Administration (TGA) has approved a shelf-life extension for certain batches of Metalyse^®. Batches shown in the below table may be used up to 12 months after the original expiry date printed on the packaging. The TGA advises that extending the shelf-life of these batches is not associated with any change in the safety or efficacy of treatment.

Clinical recommendations have also been developed by the TGA, in collaboration with expert groups, to assist healthcare professionals during this shortage. Recommendations include:

• Prioritise tenecteplase for pre-hospital thrombolysis;
• Prioritise tenecteplase for small rural and remote facilities;
• Use alteplase in metropolitan and larger regional hospitals; and
• Identify Metalyse^® from the above batches and update the packaging with the extended shelf-life to ensure stock is not accidentally discarded.

The full statement regarding these recommendations can be found here; a printable summary can be found here.

In addition, an internationally-registered brand of tenecteplase 50mg has been approved for supply in Australia under section 19A of the Therapeutic Goods Act 1989. This product is now subsidised under the existing PBS listing for tenecteplase.

Please note that alteplase is currently experiencing a significant increase in demand. To ensure the limited stock is distributed equitably, suppliers have restricted the supply of both alteplase and tenecteplase based on historical usage.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Boehringer Ingelheim on 1800 226 315 or your pharmacist at HPS Pharmacies.