Due to the current shortages of tocilizumab (Actemra) and the current COVID-19 pandemic, the Therapeutic Goods Administration (TGA) is advising that we have assessed that tocilizumab vials continue to be stable for a further six months past their labelled expiry date.
Roche Products Pty Limited (Roche), the sponsor of tocilizumab (Actemra), has notified the TGA that the shortage of tocilizumab intravenous vials will continue until January 2022.
Some states and territories have advised us that they have tocilizumab vials which will soon expire. The approved shelf-life for tocilizumab vials is 30 months with storage conditions at 2°C to 8°C.
Due to the shortage, and considering tocilizumab is a lifesaving medicine in the treatment of conditions such as cytokine release syndrome (CRS) and the off-label treatment of hospitalised COVID-19 patients, we requested stability data from Roche to assist clinicians in making decisions about use of recently expired stock.
We have assessed the additional stability data provided by Roche and based on this information, we consider there is sufficient evidence to indicate tocilizumab intravenous vials are stable for up to a total of 36 months with storage conditions at 2°C to 8°C (i.e. 6 months post the expiry date of tocilizumab vials). There is no available stability data past 36 months. This advice is being given due to the COVID-19 situation and there will be no changes to the approved shelf-life of tocilizumab products included in the product information.
Given the additional stability information provided above, clinicians should consider the risks and benefits of treating patients when only expired tocilizumab vials are available.
This advice only applies to tocilizumab (Actemra) intravenous vial products (400mg/20mL, 200mg/10mL and 80mg/4mL).
This advice does not apply to tocilizumab (Actemra) subcutaneous products (pre-filled syringe and ACTPen Autoinjector).
