Extending the date


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TGA issues guidance on post-expiry date usage of shortage-impacted treatment  

The Therapeutic Goods Administration says tocilizumab vials continue to be stable for a further six months past their labelled expiry date.

This follows the medicine being added to the list of products interchangeable at a pharmacy level. 

Roche, the manufacturer of tocilizumab (Actemra) has confirmed that it has notified the TGA that the previously reported 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,” the TGA said in a release. 

“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”.

After assessing the additional stability data provided by Roche, the TGA said “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”, or 6 months post the expiry date of the vials.

There is no available stability data past 36 months, the release stated.

“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,” the TGA added.

“Given the additional stability information provided above, clinicians should consider the risks and benefits of treating patients when only expired tocilizumab vials are available”.

The advice only applies to tocilizumab (Actemra) intravenous vial products (400mg/20mL, 200mg/10mL and 80mg/4mL), and does not apply to tocilizumab (Actemra) subcutaneous products (pre-filled syringe and ACTPen Autoinjector).

The TGA had previously made a Serious Scarcity Substitution Instrument (SSSI) for tocilizumab, declaring it as a scarce and substitutable medicine, making it interchangeable at the pharmacy level.

The SSRI covers:

  • Actemra tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled syringe (AUST R: 234034)
  • Actemra tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, ACTPen Autoinjector (AUST R: 296808)

“Both Actemra products are in short supply. This SSSI allows a pharmacist to dispense either product to a patient when one is available without prior approval to substitute from the prescriber. The pharmacist will then notify the prescriber of the substitution soon after,” the TGA said.

The SSSI is in force from 7 August 2021 until 31 December 2021. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified. 

 

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