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Shortage of tenecteplase (Metalyse)

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).

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

The TGA encourages hospital pharmacists and ambulance services to make appropriate changes to Metalyse packaging to reflect the extended shelf-life.

The TGA is working closely with BI and clinical experts to evaluate the likely impact of interruptions to Metalyse supply. In collaboration with expert groups, clinical guidelines will be developed to assist healthcare professionals during this shortage.

In addition, the TGA has approved the supply of two 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 holder, Pro Pharmaceuticals Group Pty Ltd on 1300 077 674.

(Originally published 13/07/2022 by the Therapeutic Goods Administration)