Pharmaceutical Product Information
Statement for Actemra Supply Constraints
Roche is currently experiencing shortages of multiple presentations of ACTEMRA® (tocilizumab) in Australia. This is due to a global demand for Actemra that has increased significantly, in response to the COVID-19 pandemic. The supply situation has been evolving with the pandemic, resulting in the supply of different formulations of Actemra being affected.
Roche expects to be in patient level stockout for Actemra pre-filled syringes (PFS) from August 2021 and pre-filled pens (ACTPen) from September 2021. There will be a period of time when both presentations are unavailable for up to 6 weeks. The formulations of IV are in constrained supply, please refer to the TGA website for detailed status of each formulation.
Whilst Actemra IV formulations are in short supply, we are prioritising stock to manage the needs of patients currently receiving treatment. Supply constraints will be in effect to mitigate against stockpiling and to support availability of product. Roche recognises that there are patients who need Actemra and for which there is no other alternative and we are committed to prioritising supply for these patients.
During the pandemic, the demand for Actemra has been increasing at a global level for both approved indications such as rheumatoid arthritis (RA) and the investigational treatment of COVID-19 pneumonia, which is not a registered indication in Australia. Roche has been working urgently to increase manufacturing capacity and supply by ramping up our global production network and collaborating with external partners and is working with high priority and urgency to cover the Actemra demand globally for patients currently on therapy for the treatment of giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), rheumatoid arthritis (RA) and for severe or life-threatening cytokine release syndrome (CRS), and use in COVID-19.
The global supply situation for Actemra is evolving, as the pandemic continues to impact patients around the world. Roche continues to work closely with TGA and other stakeholders with the goal of minimising the impact on patients in Australia. We will provide further information as the situation evolves.
Further information can be found on the TGA 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)