Product Stability

HPS Pharmacies wish to advise that the Therapeutic Goods Administration (TGA) has issued an alert for Actemra® vials as follows:

Actemra® Vials
Tocilizumab (rch) 400 mg/20 mL
ARTG 149402

Actemra® Vials
Tocilizumab (rch) 200 mg/10 mL
ARTG 149404

Actemra® Vials
Tocilizumab (rch) 80 mg/4 mL
ARTG 149403

Due to the current shortage of tocilizumab and the lifesaving potential of this medicine, the TGA has assessed additional stability data to assist clinicians in making decisions about the use of recently expired stock. Based on the data provided by Roche, the TGA considers there to be sufficient evidence to indicate that tocilizumab vials are stable for up to six months past the expiry date when stored at the recommended conditions of 2°C to 8°C.

This advice only applies to tocilizumab (Actemra®) vials for intravenous administration. In addition, this guidance is only being given due to the COVID-19 situation; there will be no change to the approved shelf-life in the product information. Clinicians are advised to consider the risks and benefits of treating patients with tocilizumab when only expired vials are available.

This advice does not apply to tocilizumab pre-filled syringes or ACTPen Autoinjectors for subcutaneous administration.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Roche on 1800 800 766 or your pharmacist at HPS Pharmacies.

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