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Shortages of tocilizumab (Actemra) medicines
Roche Products Pty Limited (Roche), the sponsor of tocilizumab (Actemra), has notified the Therapeutic Goods Administration (TGA) of shortages of multiple presentations of tocilizumab (Actemra) products due to global demand in response to the COVID-19 pandemic.
Actemra 200mg intravenous (IV) injection is currently in shortage until the end of August 2021.
Shortages of Actemra products are anticipated for the following estimated periods:
- Actemra 400mg IV - from August 2021 to January 2022
- Actemra 162mg/0.9mL pre-filled syringe - from mid-August 2021 to mid-October 2021
- Actemra 162mg/0.9mL pre-filled pen, ACTPen autoinjector - from September 2021 to mid-October 2021
Roche are regularly reviewing shortage dates. Any updates will be published on the Medicine Shortage Reports Database.
Actemra availability for registered use in certain types of arthritis, giant cell arteritis and cytokine release syndrome
Tocilizumab (Actemra) is used to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and cytokine release syndrome (CRS).
Whilst there are shortages of various Actemra intravenous (IV) strengths, Roche have advised there will be overall sufficient supply of other Actemra IV strengths for hospitals for the normal usage for the above indications. Roche does not expect there to be a patient level shortage of Actemra IV.
There will be a period of up to 6 weeks where both the Actemra pre-filled syringe and ACTPen autoinjector will be in shortage at patient level.
The TGA has met with Roche, the Australian Rheumatology Association and Arthritis Australia to discuss potential clinical management options during the shortage of Actemra pre-filled syringe and ACTPen autoinjector. Further information will be provided soon.
We are working closely with Roche to manage the shortages and minimise the impact on patients in Australia. Wholesalers are constraining stock to facilitate equitable supply of these medicines. Roche have advised they are prioritising stock to manage the needs of patients currently receiving treatment.
Actemra availability for off-label use in COVID-19 treatment
We are aware that tocilizumab has been recommended for treatment of certain critically ill COVID-19 patients by the World Health Organisation. Treatment of COVID-19 is not a registered indication in Australia.
The Medicine Availability Working Group, consisting of the TGA and state and territory representatives, is working with Roche to assess stock levels and model availability and distribution of tocilizumab for use in the treatment of hospitalised COVID-19 patients. The Medicine Availability Working Group is continuing to assess and monitor availability to ensure distribution is prioritised to those hospitals with COVID-19 patients.
Information for consumers
Patients should contact their prescriber for further guidance on managing treatment during the shortage.
Information for prescribers
Consider the current shortage of tocilizumab when prescribing, particularly when initiating new patients on treatment for the registered (tocilizumab) Actemra indications.
The TGA has met with Roche, the Australian Rheumatology Association and Arthritis Australia to discuss potential clinical management options during the shortage. Further information will be provided soon.
Information for pharmacists
Pharmacists should refer patients to their prescriber for further guidance on managing treatment during the shortage.