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 to increase supply globally, however uncertainty remains around the impact of emerging variants, and expected approvals of ACTEMRA for COVID-19 treatment in many countries.
Supply of ACTEMRA intravenous (IV) and ACTEMRA subcutaneous (SC) has begun to improve, although levels are yet to return to normal pre-pandemic levels. Patients who wish to resume or switch back to ACTEMRA are advised to speak to their healthcare professional.
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 beginning to improve, although availability of the different IV strengths continues to be variable due to the unprecedented global demand. Based on modelling undertaken by the Therapeutic Goods Administration (TGA) and the Australian Rheumatology Association (ARA), clinicians are advised that ACTEMRA IV formulations can now be accessed by a broader cohort of patients.
For the latest guidance on priority conditions please refer to the ARA website for the updated joint statement on patient management prepared by the TGA, the ARA and Arthritis Australia.
ACTEMRA® Subcutaneous (SC) formulations:
The supply of ACTEMRA pre-filled syringes (PFS) and ACTEMRA pre-filled pens (ACTPen) is transitioning to normal pre-pandemic levels, and constraints have been lifted.
The Serious Scarcity Substitution Instrument (SSSI) for Actemra SC formulations expired on 30 April 2022. 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.
For further enquiries about ACTEMRA® (tocilizumab) please contact Roche Medical Information on 1800 233 950 or www.medinfo.roche.com/australia.
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)