Shortage of tenecteplase

TGA

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 nameBatch numberOriginal (Printed) expiry dateExtended 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 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.

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