The Therapeutic Goods Administration (TGA) has been notified of shortages of multiple presentations of abatacept (Orencia) products due to manufacturing delays.
To assist with timely access for patients using subcutaneous formulations of abatacept (Orencia) the TGA has made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2022. This SSSI declares the following as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level:
- ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection ultrasafe passive needle guard and flange extender (AUST R: 206764)
- ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector (AUST R: 236039)
Both Orencia products are in short supply and have limited availability. This SSSI allows a pharmacist to dispense either product to a patient when one is available without prior approval to substitute from the prescriber. The pharmacist will then notify the prescriber of the substitution soon after.
The SSSI is in force from 9 February 2022 until 30 April 2022. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified. This SSSI is in effect in all states and territories.
