Pharmacy Daily | Tenecteplase shortage

THE shelf-life of batches of Boehringer Ingelheim's (BI's)thrombolysis treatment, Metalyse (tenecteplase) are being extended by 12 months in response to global supply shortages of the medication.

The Therapeutic Goods Administration (TGA) announced that both strengths of Metalyse are expected to be impacted until the end of 2023.

BI has backed the TGA's new guidance designed to preserve stock and reduce use of the medication by 35% from Oct until supply levels improve.

"Tenecteplase (Metalyse) supply must be prioritised for settings where there are no alternatives," the TGA said.

"Clinicians are asked to adopt the following recommendations from the beginning of Oct 2022.

"Prior to this, BI 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."

The regulator has called for Metalyse to be prioritised for pre-thrombolyis, small rural and remote health facilities, including Aboriginal health services, with Actilyse to be used in metropolitian and large regional hospitals.

"Any out-of-date tenecteplase products should be set aside and not disposed of," the TGA added.

The regulator has approved the extensions of the shelf-life of Metalyse (rch) 40mg powder for injection vial plus prefilled syringe batch no 007057, until 31 Jul 2023, and batch no 101396 until 30 Nov 2023, while batch no 006382 and 101397 of the 50mg preparation have been extended until 31 Jul 2023 and 30 Nov 2023 respectively.

Hospital pharmacists have been advised to make appropriate changes to Metalyse packaging to reflect the extensions.

Approvals for the supply of overseas-registered equivalent products have been granted under section 19A of the Therapeutic Goods Act 1989.

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