Pharmaceutical Product Information
Statement for Actemra Supply Constraints
The global demand for ACTEMRA® (tocilizumab) continues to be unprecedented despite the availability of vaccines and new treatment options for COVID-19. In response, Roche has been working urgently to ramp up manufacturing to increase supply globally, however, given the recent surge of infections, the uncertain impact of the new omicron variant, and expected approvals of ACTEMRA for COVID-19 treatment in additional countries, the supply of some ACTEMRA presentations in Australia will continue to be limited beyond January 2022.
Roche would like to provide the following update on the availability of ACTEMRA in Australia and its impact on patients:
ACTEMRA® Intravenous (IV) formulations:
Supply of ACTEMRA IV presentations is expected to increase from January 2022 and more stock will be available to wholesalers and hospitals. Based on modelling from the TGA Medicine Availability Working Group (MAWG), the Australian Rheumatology Association (ARA) and the Therapeutic Goods Administration (TGA), clinicians are advised that the use of ACTEMRA IV in Australia can be increased in certain cohorts of patients, in anticipation of a small replenishment of ACTEMRA IV supply expected in early January 2022. As more stock arrives, access for other patients, such as patients who have failed alternative treatments, will improve.
Please refer to the ARA clinical guidance web statement for more information about changes to patient access of ACTEMRA IV supply. We are committed to providing updates on this evolving situation as we receive them.
ACTEMRA® Subcutaneous (SC) formulations:
More stock of ACTEMRA pre-filled syringes (PFS) and ACTEMRA pre-filled pens (ACTPen) will be coming to Australia from January 2022. Supply will gradually build up to normal levels starting from this shipment. Please note that the actual supply levels of each ACTEMRA SC formulation (PFS and ACTPen) may vary over time depending on demand and arrival of supply into the country.
While the supply of ACTEMRA SC formulations is returning to normal, we remain in a very dynamic situation as the pandemic evolves in different parts of the world and we build back supply levels in Australia. Until we have confidence in continued supply for Australian patients, Roche does not recommend switching patients from ACTEMRA IV to ACTEMRA SC or initiating new rheumatoid arthritis patients on ACTEMRA SC. We are committed to providing updates on this evolving situation as we receive them.
To support patients on ACTEMRA SC formulations while supply returns to normal, the TGA has extended the Serious Scarcity Substitution Instrument (SSSI) to 30 April 2022. This SSSI declares ACTEMRA PFS and ACTPen as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level. Extension of the SSSI also enables wholesalers and pharmacies sufficient time to build levels of back up stock. Please refer to the TGA website or Federal Register of Legislation for details.
Further information:
Roche recognises the concern that the ACTEMRA shortage has caused to many patients and we are continuing to work closely with the TGA, the ARA and Arthritis Australia with the goal of minimising the impact on patients in Australia. For the most up-to-date information on shortage end dates, please refer to the TGA website.
More information is available on the TGA website.
More information for rheumatologists and prescribers is available on the Australian Rheumatology Association website.
More information for patients and consumers is available on the Arthritis Australia website.
Actemra® (tocilizumab)
Availability of Actemra® (tocilizumab):
- Pre-filled syringe for subcutaneous (SC) injection
- Pre-filled pen for subcutaneous (SC) injection
- Intravenous (IV) solution for infusion
Actemra® (tocilizumab) pre-filled syringe for subcutaneous (SC) injection
Patients
Consumer Medicine Information (CMI)
Healthcare Professionals
Product Information (PI)
Actemra® (tocilizumab) pre-filled pen for subcutaneous (SC) injection
Patients
Consumer Medicine Information (CMI)
Healthcare Professionals
Product Information (PI)
Actemra® (tocilizumab) intravenous (IV) solution for infusion
Patients
Consumer Medicine Information (CMI)
Healthcare Professionals
Product Information (PI)