The Therapeutic Goods Administration (TGA) has been notified of shortages of multiple presentations of tocilizumab (Actemra) products due to global demand in response to the COVID-19 pandemic.
To assist with timely access to patient of subcutaneous formulations of tocilizumab (Actemra) the TGA has made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Tocilizumab) Instrument 2021. This SSSI declares the following as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level:
- ACTEMRA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled syringe (AUST R: 234034)
- ACTEMRA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, ACTPen Autoinjector (AUST R: 296808)
Both Actemra products are in short supply. 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 7 August 2021 until 31 December 2021. 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.
