Shortage notice issued for multiple presentations of arthritis treatment
The Therapeutic Goods Administration (TGA) has issued a warning regarding shortages of multiple presentations of tocilizumab (Actemra).
Roche, the sponsor of tocilizumab (Actemra), notified the TGA on 21 July, saying the shortage was due to global demand in response to the COVID-19 pandemic.
In its notice, issued on 4 August, the TGA said “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
Pharmacists are being advised to “refer patients to their prescriber for further guidance on managing treatment during the shortage,” the TGA said.
“Pharmacists who are having difficulty ordering (tocilizumab) Actemra products from their regular wholesalers are advised to check other wholesalers for stock availability”.
The TGA said it has met with Roche, the Australian Rheumatology Association and Arthritis Australia to discuss potential clinical management options during the shortage.
“On 4 August 2021, we published a joint statement providing clinical guidelines to help health professionals manage this shortage”.
It added that was regularly reviewing shortage dates, and any updates will be published on the Medicine Shortage Reports Database.
In addition the TGA advised on the off-label use of tocilizumab 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”.