Pharmaceutical Product Information

Statement for Actemra Supply Constraints

Roche is currently experiencing shortages of multiple presentations of ACTEMRA® (tocilizumab) in Australia due to an increase in global and local demand in response to the COVID-19 pandemic.  Roche will not be able to resume normal levels of supply of either ACTEMRA® intravenous (IV) or subcutaneous (SC) formulations until January 2022.

Roche would like to provide the following update on the availability of ACTEMRA® in Australia and its impact on patients:

ACTEMRA® IV formulations:
Based on modelling from the Medicines Availability Working Group (MAWG), the Australian Rheumatology Association (ARA) and Therapeutic Goods Administration (TGA) have advised clinicians that the use of ACTEMRA® IV in Australia needs to be significantly reduced in order to preserve remaining stock and to ensure that patients who have no alternatives can be treated.  Please refer to the TGA website for the joint statement on patient management and supply allocations of ACTEMRA® IV, including information on priority indications as determined by the ARA and TGA.

In addition, Roche is collaborating with the TGA, MAWG, ARA, Medicines Australia and wholesalers to allocate agreed amounts of the available supply of ACTEMRA® IV to customers.  Effective immediately, all supply of ACTEMRA® will only be via wholesalers.  Roche will not supply ACTEMRA® IV directly to any hospitals or pharmacies.

ACTEMRA® Subcutaneous formulations:
There is limited stock of ACTEMRA® pre-filled syringes (PFS) and ACTEMRA® pre-filled pens (ACTPen).  Please refer to the TGA website for detailed status of each formulation.  Roche has also put its ACTEMRA® sampling program on hold.

Due to the limited availability of ACTEMRA® SC formulations, Roche does not recommend switching patients from IV to SC during this period of shortage.  A joint statement has been developed by the TGA, the ARA and Arthritis Australia, providing guidance for prescribers to manage patients on ACTEMRA® during this period of constrained supply.  Please refer to the TGA website for this information.

The TGA has issued a Serious Scarcity Substitution Instrument (SSSI) to assist with timely access to ACTEMRA® SC formulations for patients effective until 31 December 2021.  This SSSI declares ACTEMRA® PFS and ACTPen as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level.  Please refer to the TGA website for details.

Further information:
The global supply situation for ACTEMRA® is constantly evolving.  In order to address this, Roche is using its best endevours to increase manufacturing capacity and supply by leveraging its global networks and collaborating with external partners to cover the ACTEMRA® demand globally for patients currently on therapy.

Roche continues to work closely with the 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
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Actemra® (tocilizumab) pre-filled pen for subcutaneous (SC) injection

Patients
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Actemra® (tocilizumab) intravenous (IV) solution for infusion

Patients
Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)