THE pharmaceutical company Boehringer Ingelheim (BI) has notified the TGA that the shortage of its thrombolytic product, tenecteplase, is set to continue.
The shortage was due to manufacturing capacity constraints following increases in global demand and was expected to last until the end of 2023 (PD 25 Aug 2022).
BI has now informed the TGA that the shortage of tenecteplase will continue until 31 Dec 2024.
The TGA stated that the conservation strategies for medicines currently employed nationwide will continue to apply.
BI has said it will continue to work closely with states and territories to allocate stock of tenecteplase and facilitate equitable access to all Australians who may need it.
The company told the TGA it was confident the supply of stock throughout 2024 would meet the demand established in 2023.
BI said it is also working to expedite the approval of new manufacturing sites to increase the supply of stock, but there remains a strong global demand for these critical medicines.
The tenecteplase (Metalyse) injection is used to dissolve blood clots in the immediate period following a heart attack.
The TGA explained that given the importance of the medicine in critical care settings, it has worked with the company to facilitate ongoing access and equitable supply throughout the shortage.
This includes publishing a joint statement for clinicians, and outlining new clinical advice for the use of tenecteplase in critical care situations, the TGA stated.
In addition, the TGA has extended the shelf life of some batches of tenecteplase to reduce wastage and maximise access, and approved the supply of overseas-registered equivalent products under sect. 19A of the Therapeutic Goods Act 1989.
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